Effectiveness of an internet-based self-guided program to treat depression in a sample of Brazilian users: a study protocol

Rodrigo T. Lopes Björn Meyer Thomas Berger Maria A. Svacina About the authors

Abstract

Although psychological treatments for depressive disorders are available, they are often expensive or inaccessible for many. Web-based interventions that require minimal or no contact with therapists have been shown effective. To the best of our knowledge, no study using this treatment format has been conducted in Brazil. The Deprexis program was designed using empirically established principles of cognitive-behavioral therapy to reduce depressive symptoms. The objective of this study was to evaluate the effectiveness of Deprexis in Brazil. This randomized controlled trial will include 128 Brazilians with clinically significant depression symptoms or who have been diagnosed with depressive disorder (major depressive disorder or dysthymia), recruited over the internet (Brazilian forums, social networks, or e-mail lists). Individuals with other psychiatric diagnoses that require significant attention (e.g., bipolar disorder, psychosis) will not be included in the trial. Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks). Participants will be able to obtain other treatment types in addition to the online intervention. If found effective, this web-based intervention would increase the evidence-based care options for depression treatment in Brazil.

Clinical trial registration:

RBR-6kk3bx, UTN U1111-1212-8998

Depression; online interventions; self-guided interventions; cognitive-behavioral psychotherapy


Introduction

Major depressive disorder (MDD) and dysthymia are characterized by symptoms such as a sad, empty or irritable mood, anhedonia and specific somatic and cognitive changes that reduce quality of life and affect an individual’s social and occupational functioning.11. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Arlington: American Psychiatric Publishing; 2013. Depression is one of the leading causes of functional impairment.22. Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, et al. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013;10:e1001547.

3. Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997;349:1436-42.
-44. Üstün TB, Ayuso-Mateos JL, Chatterji S, Mathers C, Murray CJL. Global burden of depressive disorders in the year 2000. Br J Psychiatry. 2004;184:386-92. Suicide is strongly related to depression; in fact, about half of those who attempt suicide are depressed, and as many as 15% of people suffering from depression will commit suicide.55. Hollon SD, Thase ME, Markowitz JC. Treatment and prevention of depression. Psychol Sci Public Interest. 2002;3:39-77. The estimated economic burden of depression includes direct medical costs (31%), costs related to mortality from suicide (7%), and costs associated with occupational impairment (62%).66. Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, et al. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003;64:1465-75. Still, depressive disorders are among the most common mental health problems for which help is sought.77. Andrews PW, Thomson JA Jr. The bright side of being blue: depression as an adaptation for analyzing complex problems. Psychol Rev. 2009;116:620-54.,88. Roness A, Mykletun A, Dahl AA. Help-seeking behaviour in patients with anxiety disorder and depression. Acta Psychiatr Scand. 2005;111:51-8. Evidence suggests that those who most need help (i.e., the people with more severe depressive symptoms) seek treatment the least.99. Moritz S, Schröder J, Meyer B, Hauschildt M. The more it is needed, the less it is wanted: attitudes toward face-to-face intervention among depressed patients undergoing online treatment. Depress Anxiety. 2013;30:157-67.

Although some psychological treatments for unipolar depression have been supported by evidence,1010. Hayes A, Strunk D. Research-supported psychological treatments for depression [Internet]. [cited 2020 Jan 17]. https://www.div12.org/diagnosis/depression/
https://www.div12.org/diagnosis/depressi...
this evidence is debatable, in part due to potential publication bias.1111. Driessen E, Hollon SD, Bockting CL, Cuijpers P, Turner EH. Does publication bias inflate the apparent efficacy of psychological treatment for major depressive disorder? A systematic review and meta-analysis of US national institutes of health-funded trials. PloS One. 2015;10:e0137864. Furthermore, a considerable number of patients abandon treatment without substantial improvement or relapse after treatment.1212. Cuijpers P, Andersson G, Donker T, van Straten A. Psychological treatment of depression: results of a series of meta-analyses. Nord J Psychiatry. 2011;65:354-64.,1313. Lopes RT, Gonçalves MM, Fassnacht DB, Machado PP, Sousa I. Long-term effects of psychotherapy on moderate depression: a comparative study of narrative therapy and cognitive-behavioral therapy. J Affect Disord. 2014;167:64-73. A large proportion of depressed people receive no treatment at all.1414. Kazdin AE. Addressing the treatment gap: a key challenge for extending evidence-based psychosocial interventions. Behav Res Ther. 2017;88:7-18. General barriers to psychotherapy include its high costs, extensive commutes, time constraints, negative evaluations of psychotherapy, and availability of services.1515. Mohr DC, Ho J, Duffecy J, Baron KG, Lehman KA, Jin L, et al. Perceived barriers to psychological treatments and their relationship to depression. J Clin Psychol. 2010;66:394-409.,1616. Möller-Leimkühler AM. Barriers to help-seeking by men: a review of sociocultural and clinical literature with particular reference to depression. J Affect Disord. 2002;71:1-9. Moreover, in many parts of the world, there is a shortage of qualified professionals, especially in areas far from urban centers,1717. Wang PS, Berglund P, Olfson M, Pincus HA, Wells KB, Kessler RC. Failure and delay in initial treatment contact after first onset of mental disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:603-13. while in large centers the most affordable services have long waiting lists. It is also known that many clients do not seek help due to the stigma associated with psychological and psychopharmacological treatment.1818. Schnyder N, Panczak R, Groth N, Schultze-Lutter F. Association between mental health-related stigma and active help-seeking: systematic review and meta-analysis. Br J Psychiatry. 2017;210:261-8. Specific barriers to treatment have been found among depressed people, such as lack of motivation, emotional concerns,1515. Mohr DC, Ho J, Duffecy J, Baron KG, Lehman KA, Jin L, et al. Perceived barriers to psychological treatments and their relationship to depression. J Clin Psychol. 2010;66:394-409. and negative perception of the effectiveness of psychotherapy.99. Moritz S, Schröder J, Meyer B, Hauschildt M. The more it is needed, the less it is wanted: attitudes toward face-to-face intervention among depressed patients undergoing online treatment. Depress Anxiety. 2013;30:157-67. Thus, research on different treatment formats has been recommended,1919. Chambless DL, Baker-Ericzen, Baucom DH, Beutler LE, Calhoun KS, Crits-Christoph P, et al. Update on empirically validated therapies II. Clin Psychol. 1998;51:3-16.

20. Chambless DL, Hollon SD. Defining empirically supported therapies. J Consult Clin Psychol. 1998;66:7-18.

21. Kendall PC. Empirically supported psychological therapies. J Consult Clin Psychol. 1998;66:3-6.
-2222. Kendall PC, Holmbeck G, Verduin T. Methodology, design, and evaluation in psychotherapy research. In: Lambert MJ, editor. Bergin and Garfield’s handbook of psychotherapy and behavior change. 5th ed. New York: Wiley; 2004. p. 16-43. and Internet treatments have gained popularity in recent years.2323. Apolinário-Hagen J, Kemper J, Stürmer C. Public acceptability of e-mental health treatment services for psychological problems: a scoping review. JMIR Ment Health. 2017;4:e10.,2424. Barak A, Grohol JM. Current and future trends in internet-supported mental health interventions. J Technol Hum Serv. 2011;29:155-96.

There is a clear distinction between online psychotherapy and Internet-based self-administered interventions. Online psychotherapy is usually synchronous, performed by professionals via virtual interaction platforms (e.g., Skype®), and does not exclude the possibility of face-to-face interaction. Internet-based psychological interventions are usually asynchronous, conducted through self-administered programs that target psychoeducation and involve therapeutic tasks that are structured and systematic. Little contact with a therapist is presumed, since their perspective is support and problem solving. The advantages of online, self-guided interventions include potentially lower costs, greater geographic reach, privacy, flexibility (treatment is available anytime and anywhere Internet access is available), the ability to repeat exercises, and adaptation to the client’s everyday context rather than the therapist’s office. Research outside Brazil, mainly in Switzerland, Sweden, the Netherlands, Germany, Australia, and the United Kingdom, suggests that some (but not all) internet-based self-guided psychological interventions are effective.2525. Andersson G, Carlbring P, Berger T, Almlöv J, Cuijpers P. What makes internet therapy work? Cogn Behav Ther. 2009;38 Supll 1:55-60.

26. Andersson G, Hesser H, Hummerdal D, Bergman-Nordgren L, Carlbring P. A 3.5-year follow-up of Internet-delivered cognitive behavior therapy for major depression. J Ment Health. 2013;22:155-64.

27. Berger T, Caspar F, Richardson R, Kneubühler B, Sutter D, Andersson G. Internet-based treatment of social phobia: a randomized controlled trial comparing unguided with two types of guided self-help. Behav Res Ther. 2011;49:158-69.

28. Berger T, Andersson G. Internet-based treatments – experiences from Sweden: an interview with Gerhard Andersson. Verhaltenstherapie. 2013;23:211-4.

29. Berger T, Hämmerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40:251-66.
-3030. Messerli-Bürgy N, Barth J, Berger T. The InterHerz project – a web-based psychological treatment for cardiac patients with depression: study protocol of a randomized controlled trial. Trials. 2012;13:245. Evidence from direct comparisons suggests that Internet-based interventions with some therapist support are as effective as face-to-face interventions.3131. Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010;40:1943-57.,3232. Hedman E, Andersson G, Ljótsson B, Andersson E, Rück C, Mörtberg E, et al. Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: a randomized controlled non-inferiority trial. PLoS One. 2011;6:e18001. In an individual patient-level meta-analysis reviewing the efficacy of self-guided internet-based interventions (without assistance from therapists) for depression, an average effect size of d = 0.27 was reported,3333. Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, et al. Efficacy of self-guided internet-based cognitive behavioral therapy in the treatment of depressive symptoms: a meta-analysis of individual participant data. JAMA Psychiatry. 2017;74:351-9. which is considered a small effect.3434. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale: Erlbaum; 1988. However, programs may differ in efficacy. For example, a meta-analysis of a specific Internet intervention for depression (Deprexis) reported large effect sizes averaging d = 0.54, based on eight randomized controlled trials conducted in German-speaking countries and the United States.3535. Twomey C, O’Reilly G, Bültmann O, Meyer B. Effectiveness of an individually-tailored computerised CBT programme (deprexis) for depression: a meta-analysis. PLoS One. 2020;256:371-7.

In Brazil, the Federal Council of Psychology regulates the Internet-mediated psychological practice with Resolution 011/2018.3636. Conselho Federal de Psicologia. Resolução CFP n° 011/2018: Regulamenta a prestação de serviços psicológicos realizados por meios de tecnologias da informação e da comunicação e revoga a Resolução CFP n° 11/2012. http://site.cfp.org.br/wp-content/uploads/2018/05/RESOLU%C3%87%C3%83O-N%C2%BA-11-DE-11-DE-MAIO-DE-2018.pdf
http://site.cfp.org.br/wp-content/upload...
In this document, Brazilian psychologists are authorized to provide treatment through online services such as Skype®, FaceTime®, and text services (e-mail, chat applications, messaging, etc.). However, research on such interventions is at an early stage3737. Pieta MAM, Gomes WB. Psicoterapia pela internet: viável ou inviável? Psicol Cienc Prof. 2014;34:18-31. and, to date, very few empirical studies assessing online treatment effectiveness have been conducted. We know of no studies in Brazil that have evaluated the effectiveness of an Internet-based intervention for a psychological problem in a controlled manner. Thus, more studies on the results and processes of Internet-based psychotherapy are necessary to better evaluate the impact of this type of treatment with potential users in Brazilian.3737. Pieta MAM, Gomes WB. Psicoterapia pela internet: viável ou inviável? Psicol Cienc Prof. 2014;34:18-31.

Deprexis (https://deprexis.broca.io/en/) is an established online intervention for depression that has already been tested in 12 randomized controlled trials.3535. Twomey C, O’Reilly G, Bültmann O, Meyer B. Effectiveness of an individually-tailored computerised CBT programme (deprexis) for depression: a meta-analysis. PLoS One. 2020;256:371-7.,3838. Berger T, Krieger T, Sude K, Meyer B, Maercker A. Evaluating an e-mental health program (“deprexis”) as adjunctive treatment tool in psychotherapy for depression: results of a pragmatic randomized controlled trial. J Affect Disord. 2018;227:455-62.

39. Bücker L, Bierbrodt J, Hand I, Wittekind C, Moritz S. Effects of a depression-focused internet intervention in slot machine gamblers: a randomized controlled trial. PloS One. 2018;13:e0198859.

40. Fuhr K, Fahse B, Hautzinger M, Gulewitsch MD. Erste Erfahrungen zur Implementierbarkeit einer internet-basierten Selbsthilfe zur Überbrückung der Wartezeit auf eine ambulante Psychotherapie. Psychother Psych Med. 2018;68:234-41.
-4141. Zwerenz R, Becker J, Knickenberg RJ, Siepmann M, Hagen K, Beutel ME. Online self-help as an add-on to inpatient psychotherapy: efficacy of a new blended treatment approach. Psychother Psychosom. 2017;86:341-50.. Deprexis uses an integrative approach, based primarily on cognitive behavioral therapy.4242. Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (deprexis): randomized controlled trial. J Med Internet Res. 2009;11:e15. Evidence for the effectiveness of this program has been reported in Europe, especially German-speaking countries2929. Berger T, Hämmerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40:251-66.,4242. Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (deprexis): randomized controlled trial. J Med Internet Res. 2009;11:e15.

43. Fischer A, Schröder J, Vettorazzi E, Wolf OT, Pöttgen J, Lau S, et al. An online programme to reduce depression in patients with multiple sclerosis: a randomised controlled trial. Lancet Psychiatry. 2015;2:217-23.

44. Klein JP, Berger T, Schröder J, Späth C, Meyer B, Caspar F, et al. Effects of a psychological internet intervention in the treatment of mild to moderate depressive symptoms: results of the EVIDENT study, a randomized controlled trial. Psychother Psychosom. 2016;85:218-28.

45. Meyer B, Bierbrodt J, Schröder J, Berger T, Beevers CG, Weiss M, et al. Effects of an Internet intervention (deprexis) on severe depression symptoms: randomized controlled trial. Internet Interv. 2015;2:48-59.

46. Moritz S, Schilling L, Hauschildt M, Schröder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012;50:513-21.
-4747. Schröder J, Brückner K, Fischer A, Lindenau M, Köther U, Vettorazzi E, et al. Efficacy of a psychological online intervention for depression in people with epilepsy: a randomized controlled trial. Epilepsia. 2014;55:2069-76., as well as in the United States.4848. Beevers CG, Pearson R, Hoffman JS, Foulser AA, Shumake J, Meyer B. Effectiveness of an internet intervention (deprexis) for depression in a united states adult sample: a parallel-group pragmatic randomized controlled trial. J Consult Clin Psychol. 2017;85:367-80. However, these results were obtained in high-income countries. This program has been translated into eight languages, including Brazilian Portuguese, and some efforts have already been made for cultural adaptation to Brazil, although no study has been conducted with groups of Brazilians suffering from depression.

The main objective of this study is to replicate empirical effectiveness studies conducted in other countries, using Deprexis in the Brazilian cultural context. Therefore, the main research question is: will the therapeutic results (i.e., reduction of depressive symptoms) in Brazil be similar those obtained in other countries (i.e., medium to large effect sizes, compared to treatment as usual [TAU])?

Methods

This study will be a randomized controlled trial with a parallel-group design. The selected participants will be allocated randomly into two groups: 1) immediate access to Deprexis; and 2) a wait-list control group that receives delayed access to Deprexis. Both groups will be allowed access to any other treatments that they or their care providers deem necessary, i.e., TAU (psychotherapy, psychopharmacology, or both). Deprexis will be used alone or together with TAU.

Participants

Participants must have the following characteristics for inclusion in the study: 1) be at least 18 years of age; 2) have regular Internet access; 3) be diagnosed with a depressive disorder (MDD or dysthymia) according to DSM-5 definitions1; or 4) present clinically relevant depressive symptoms, i.e. a score of at least 10 on the Patient Health Questionnaire-9 (PHQ-9).4949. Santos IS, Tavares BF, Munhoz TN, de Almeida LSP, da Silva NTB, Tams BD, et al. Sensibilidade e especificidade do Patient Health Questionnaire-9 (PHQ-9) entre adultos da população geral. Cad Saude Publica. 2013;29:1533-43.,5050. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999;282:1737-44. Participants may be undergoing any other psychopharmacological or psychotherapeutic treatment (TAU) to manage their depressive symptoms. Participants will be excluded from the study if they: 1) present other severe psychiatric symptoms that are the primary focus of specific clinical attention (e.g., severe psychotic symptoms, manic episodes); 2) show the potential to injure themselves or others; 3) present severe suicidal ideation; 4) are psychiatric patients adapting to medication (having been on medication for less than a month, or having changed their dosage in the past month, or intending to switch medications within 3 months after the trial starts); 5) do not have regular Internet access; or 6) are using illegal drugs or have high alcohol intake (more than three drinks per day). Candidates ineligible for the study will be contacted (by telephone, e-mail, or during the interview) for feedback on the initial evaluation and will be referred to face-to-face public mental health services in their area. Using simple randomization procedures (computerized random numbers), the selected participants will be randomly assigned to either TAU plus immediate access to Deprexis, or TAU plus delayed access to Deprexis (after 8 weeks). The randomization scheme will be generated with a random algorithm developed at http://www.randomization.com. To ensure allocation concealment, the research team members performing the randomization will not be aware of any participant characteristics. The research team member who randomly allocates participants in both groups will be different from the one who applies inclusion/exclusion criteria, and these research team members will not have contact with each other.

Recruitment

A website (https://sites.google.com/view/ficabem/), a Facebook page (@p.ficabem) and an Instagram profile (@p.ficabem) have been set up to provide necessary information about the research procedures and online intervention, as well as to recruit participants. The link will be advertised on the main social networks and e-mail lists of associations of mental health professionals in Brazil. We also intend to announce the research opportunity in traditional media and mental health services.

Eligibility assessment

Potential participants will be asked to complete a consent form, the sociodemographic questionnaire, the PHQ-9, and the Clinical Outcome in Routine Evaluation – Outcome Measurement (CORE-OM) when logging on to the study platform for the first time. In order to assess the exclusion and inclusion criteria and confirm the severity of depressive symptoms, an interview based on the Adult DSM-5 Cross-Cutting Symptom Measure11. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Arlington: American Psychiatric Publishing; 2013. will be held by phone or on online platforms such as Skype® or WhatsApp®.

Instruments

Sociodemographic questionnaire

The assessed demographic variables will be age, gender, location in Brazil, and Internet access.

Adult DSM-5 Cross-Cutting Symptom Measure

For the initial screening, a semi-structured diagnostic interview based on DSM-5 diagnostic criteria will be applied. The interview assesses mental health domains that are important across psychiatric diagnoses. The adult version of the measure consists of 23 questions that evaluate 13 psychiatric domains, including depression, suicidal ideation, mania, anxiety, anger, somatic symptoms, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. The original English version of the measure had good to excellent test-retest reliability in DSM-5 field trials conducted in adult clinical samples across the United States and Canada.5151. Mościcki EK, Clarke DE, Kuramoto SJ, Kraemer HC, Narrow WE, Kupfer DJ, et al. Testing DSM-5 in routine clinical practice settings: feasibility and clinical utility. Psychiatr Serv. 2013;64:952-60.,5252. Narrow WE, Clarke DE, Kuramoto SJ, Kraemer HC, Kupfer DJ, Greiner L, et al. DSM-5 field trials in the United States and Canada, Part III: development and reliability testing of a cross-cutting symptom assessment for DSM-5. Am J Psychiatry. 2013;170:71-82. We included questions about any previous diagnosis and former and current treatments.

Patient Health Questionnaire4949. Santos IS, Tavares BF, Munhoz TN, de Almeida LSP, da Silva NTB, Tams BD, et al. Sensibilidade e especificidade do Patient Health Questionnaire-9 (PHQ-9) entre adultos da população geral. Cad Saude Publica. 2013;29:1533-43.,5050. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999;282:1737-44.

Consisting of nine questions, the PHQ-9 assesses the presence of each of the symptoms for a major depressive episode described in the DSM-5.11. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Arlington: American Psychiatric Publishing; 2013. The nine symptoms include depressed mood, anhedonia (loss of interest in or inability to experience pleasure from normally pleasant stimuli), sleeping problems, tiredness or lack of energy, change in appetite or weight, feelings of guilt or uselessness, concentration problems, feelings of lethargy or restlessness, and suicidal thoughts. Brazilian psychiatrists translated the PHQ-9 into Portuguese and a back translation was performed by one of the authors of the original instrument.5353. Fraguas R Jr, Henriques SG Jr, De Lucia MS, Iosifescu DV, Schwartz FH, Menezes PR, et al. The detection of depression in medical setting: a study with PRIME-MD. J Affect Disord. 2006;91:11-7. The frequency of each symptom in the previous 2 weeks is assessed on a Likert scale from 0 to 3 corresponding to “never,” “several days,” “more than half of the days,” and “almost every day,” respectively. The questionnaire also includes a 10th question to assess the interference of these symptoms in daily activities, such as work and study. The cutoff score will be 10 points, as is widely used among Brazilian researchers.4949. Santos IS, Tavares BF, Munhoz TN, de Almeida LSP, da Silva NTB, Tams BD, et al. Sensibilidade e especificidade do Patient Health Questionnaire-9 (PHQ-9) entre adultos da população geral. Cad Saude Publica. 2013;29:1533-43.,5454. Morilha A, Karagulian S, Lotufo PA, Santos IS, Benseñor IM, Goulart AC. Abuso de álcool após síndrome coronariana aguda: avaliação prospectiva no estudo ERICO. Arq Bras Cardiol. 2015;104:457-67.

55. Silva M de M e, Mercer PBS, Witt MCZ, Pessoa RGR, Viveiros CP, Gazola BB, et al. Testes de rastreio para alterações psiquiátricas em esclerose múltipla – revisão sistemática com metanálise. J Bras Psiquiatr. 2018;67:255-63.
-5656. de Lima Osório F, Vilela Mendes A, Crippa JA, Loureiro SR. Study of the discriminative validity of the PHQ-9 and PHQ-2 in a sample of Brazilian women in the context of primary health care. Perspect Psychiatr Care. 2009;45:216-27.

Clinical Outcome in Routine Evaluation – Outcome Measurement5757. Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, et al. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002;180:51-60.,5858. Santana MRM, da Silva MM, de Moraes DS, Fukuda CC, Freitas LH, Ramos ME, et al. Brazilian Portuguese version of the CORE-OM: cross-cultural adaptation of an instrument to assess the efficacy and effectiveness of psychotherapy. Trends Psychiatry Psychother. 2015;37:227-31.

The CORE-OM is a widely used self-report scale for evaluating the effectiveness of mental health treatments. It includes 34 items assessing the following four domains: subjective well-being (four items), problems and symptoms (12 items), life functioning (12 items), and risk to self and others (six items). These items are answered on a five-point scale, ranging from “never” to “always.” A UK study with a clinical (n=890) and a non-clinical sample (n=1,106) found an overall internal consistency index (Cronbach’s alpha) of 0.94 for both samples. Test-retest correlations with part of the sample (n=55) ranged from 0.87 to 0.91 for well-being, problems and symptoms, and life functioning domains, although the risk to self and others domain scored 0.64, showing low temporal stability. Convergent validity was verified by correlating total scores and domain scores with overall scores from other psychological symptom scales, resulting in correlations ranging from 0.55 to 0.88.7.5757. Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, et al. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002;180:51-60.

Client Satisfaction Questionnaire (CSQ-8)5959. Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5:233-7.

The CSQ-8 is a self-report questionnaire designed to assess the general level of satisfaction with provided services. Its eight items are scored on a scale from 1 to 4. Total scores vary from 8 to 32 points, with higher scores indicating greater satisfaction with the service. The internal consistency of the original English version scale ranges from 0.83 to 0.93.6060. Attkisson CC, Greenfield TK. The UCSF client satisfaction scales: I. The client satisfaction questionnaire-8. In: Maruish ME, editor. The use of psychological testing for treatment planning and outcomes assessment: instruments for adults. Vol. 3. 3th ed. Mahwah: Lawrence Erlbaum Associates Publishers; 2004. p. 799-811.

Usage duration

We will measure the number of sessions lasting at least 10 minutes spent in the program, as well as the number of days with such usage. The system generates these indicators based on each client’s use as an objective measure of treatment adherence.

Procedures

The informed consent and self-report measures will be obtained online by participants at the initial screening questionnaire, prior to inclusion and randomization. Participants will confirm that they read and consented to the terms of the study. They may also discontinue participation, as well as contact the staff for further information. After completing the baseline assessment and being included in the study, participants randomized to the intervention group will promptly receive a voucher to access the program for 90 days. The time point of primary interest will be 8 weeks after the baseline assessment. Participants randomized to the delayed access group will receive a voucher 8 weeks after randomization and will be asked to fill out the primary (PHQ-9) and secondary (CORE-OM) outcome measures once more. After completing the program, all participants will be invited to fill out the outcome measures and answer a final questionnaire that includes items on whether the program was used alone or together with psychotherapy or psychopharmacology. The participants will also be asked about significant life events that occurred during the course of the intervention.

The research team includes senior undergraduate psychology students, who will be in charge of the screening interviews. These students will be trained and supervised by three clinical psychologists on the research team. The interviews will be assigned by convenience and according to availability. The research team will also be responsible for: 1) recruitment advertising; 2) analyzing the screening questionnaires and excluding participants who do not follow the criteria; 3) randomizing participants and following up questionnaire responses; 4) e-mail communication with participants throughout the study; 5) checking and providing feedback about program usage; and 6) sending out post-treatment assessment forms; 7) in accordance with procedures used in a previous study on Deprexis (Beevers et al.4848. Beevers CG, Pearson R, Hoffman JS, Foulser AA, Shumake J, Meyer B. Effectiveness of an internet intervention (deprexis) for depression in a united states adult sample: a parallel-group pragmatic randomized controlled trial. J Consult Clin Psychol. 2017;85:367-80.), the research team will send messages to participants every 2 weeks to encourage them to use Deprexis, to assess potential problems or difficulties, and to monitor potentially adverse events they might experience during the intervention.

Treatment

Deprexis is an internet-based intervention program to help people learn about and cope with depressive symptoms.4242. Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (deprexis): randomized controlled trial. J Med Internet Res. 2009;11:e15. It is based on the principles of cognitive-behavioral therapy and consists of 10 original content modules plus one short review module, including psychoeducation, behavioral activation, cognitive restructuring, mindfulness and acceptance, social and communication skills, relaxation exercises, suggestions for physical activity and healthy dieting, problem solving methods, expressive writing, and forgiveness, as well as working with dreams from a cognitive-behavioral perspective.4242. Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (deprexis): randomized controlled trial. J Med Internet Res. 2009;11:e15.,6161. Krieger T, Meyer B, Sude K, Urech A, Maercker A, Berger T. Evaluating an e-mental health program (“deprexis”) as adjunctive treatment tool in psychotherapy for depression: design of a pragmatic randomized controlled trial. BMC Psychiatry. 2014;14:285. Content is presented in simulated dialogue format, in which users continuously choose one of several predetermined response options, and subsequent content is automatically adapted to user needs and characteristics.

Deprexis sends daily messages with therapeutic content to help in everyday life (e.g., becoming aware of unhelpful automatic thoughts, organizing the day, breaking down significant problems into small steps, and interacting with people). Deprexis is designed for both mobile and desktop devices. The program can be used without any therapist contact, although in our clinical trial trained clinical psychologists and psychology students will keep minimal regular contact with users by e-mail (i.e., minimally supported or guided use). Deprexis has been carefully translated and adapted to Brazilian Portuguese and culture by expert Portuguese language professionals. In addition, Brazilian psychology students and psychologists used the program and suggested language and cultural adjustments

Sample size and statistical analyses

The sample size of this study is based on the expected difference in the primary outcome variable (PHQ-9 score, which measures the severity of depressive symptoms) between the group receiving the intervention and the control group after 3 months. Based on a statistical strength estimate of at least 0.80 in a two-tailed test and an alpha of 0.05, a sample of 128 participants (64 per group) will be sufficient to demonstrate a likely effect size of d = 0.50 (moderate effect). Following the intention-to-treat principle, data from all 128 randomized participants will be analyzed. We anticipate a treatment withdrawal rate of around 20% at the first measurement point (after 3 months). This rate has been achieved in several prior clinical trials with Deprexis.4848. Beevers CG, Pearson R, Hoffman JS, Foulser AA, Shumake J, Meyer B. Effectiveness of an internet intervention (deprexis) for depression in a united states adult sample: a parallel-group pragmatic randomized controlled trial. J Consult Clin Psychol. 2017;85:367-80. Based on previous research,2929. Berger T, Hämmerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011;40:251-66.,3535. Twomey C, O’Reilly G, Bültmann O, Meyer B. Effectiveness of an individually-tailored computerised CBT programme (deprexis) for depression: a meta-analysis. PLoS One. 2020;256:371-7.,4242. Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (deprexis): randomized controlled trial. J Med Internet Res. 2009;11:e15.,4747. Schröder J, Brückner K, Fischer A, Lindenau M, Köther U, Vettorazzi E, et al. Efficacy of a psychological online intervention for depression in people with epilepsy: a randomized controlled trial. Epilepsia. 2014;55:2069-76.,4848. Beevers CG, Pearson R, Hoffman JS, Foulser AA, Shumake J, Meyer B. Effectiveness of an internet intervention (deprexis) for depression in a united states adult sample: a parallel-group pragmatic randomized controlled trial. J Consult Clin Psychol. 2017;85:367-80. predicting a moderate effect size seems realistic. This calculation is based on the assumption that a 50:50 randomization procedure will be used.

Both the intention-to-treat and the per protocol analyses will be conducted using appropriate statistical methods, such as linear mixed models, which are widely used in this field of research and have been recommended due to their ability to properly treat lost data. Additional analyses will be performed to examine the potential influence of intervening variables on the primary outcome measure (e.g., initial differences in symptom severity or intensity of Deprexis use). The PHQ-9 will be the primary clinical outcome measure, and the CORE-OM will be the secondary outcome measure. The results will be reported according to CONSORT guidelines.6262. Eysenbach G, Consort-Ehealth Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13:e126.,6363. Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:1987-91.

The clinical significance of the changes observed at the end of the intervention in both experimental conditions will be evaluated using the Jacobson & Truax6464. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12-9. method. This analysis method takes into account the scores of the general and clinical populations to obtain a clinical threshold for a given psychological measure. Chi-square tests will be used to compare the rates of clinical improvement and recovery, as well as any clinically significant deterioration ratios between groups.

Ethics statement

This research protocol has been approved by the research ethics committee of the Universidade Católica de Petrópolis (CAAE # 68709517.1.0000.5281) and has been registered in the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos [ReBEC]; RBR-6kk3bx, UTN U1111-1212-8998; http://www.ensaiosclinicos.gov.br/rg/RBR-6kk3bx/). Similar experimental protocols using Deprexis have already been approved by the research ethics committees of several European and U.S. universities, as well as the Data Security Department of Hamburg, Germany. The ethics code for practicing psychology in Brazil6565. Conselho Federal de Psicologia. Código de Ética Profissional do Psicólogo [Internet]. 2005 [cited 2014 Sep 30]. http://site.cfp.org.br/wp-content/uploads/2012/07/codigo_etica1.pdf
http://site.cfp.org.br/wp-content/upload...
and previously mentioned Federal Council of Psychology guidelines for internet interventions (Resolution 011/2018)3636. Conselho Federal de Psicologia. Resolução CFP n° 011/2018: Regulamenta a prestação de serviços psicológicos realizados por meios de tecnologias da informação e da comunicação e revoga a Resolução CFP n° 11/2012. http://site.cfp.org.br/wp-content/uploads/2018/05/RESOLU%C3%87%C3%83O-N%C2%BA-11-DE-11-DE-MAIO-DE-2018.pdf
http://site.cfp.org.br/wp-content/upload...
are also being taken into account.

All selected clients who decide to participate in the study will be required to complete an informed consent form approved by the local research ethics committee. The participants’ e-mail addresses will be collected for logging in to Deprexis, retrieving lost passwords, and receiving daily messages. No participant names, addresses, or internet protocol addresses will be stored after the trial is completed. Stored data security will be ensured through the secure sockets layer protocol, which provides internet communication security for services such as e-mail, page navigation, and other types of data transfer. The intervention data will be stored on a secure server in Germany and will be protected by a modern, reliable firewall, and a current transport layer security configuration to encrypt all data in transit. Users will provide their e-mail addresses and a personal password, which is encrypted by the system. Thus, passwords, even if stolen, cannot be used. All employees of GAIA Group’s information technology department are trained in data privacy and are governed by German law.

Discussion

This study was designed in an effort to meet a perceived need for research on different depression intervention formats, especially in low- to middle-income countries, such as Brazil. The effectiveness of internet-based interventions suggests that this could be a viable alternative in depression treatment due to its flexibility, lower costs, and adaptability to the patient’s daily routine and location. As far as we know, no web-based interventions for depression have been developed in Brazil. We are aware of the considerable amount of human resources necessary to develop such an intervention. Deprexis has been developed for many years now and has undergone numerous improvements. It has been carefully translated and adapted to the Brazilian Portuguese language and culture. It is expected that this study will replicate and extend the evidence found in previous studies on Deprexis.

We are currently recruiting the first participants. We have chosen to recruit participants over the Internet, assuming that this is the primary medium through which they would hear about the program under similar conditions. Although online recruitment introduces a selection bias toward individuals suffering from depressive symptoms who actively seek help online, such individuals can also be considered the intended target group for Deprexis. Deprexis can also be recommended to patients by their psychiatrists or psychologists, but they will not be the main focus of our recruitment strategy, which could be regarded as a possible study limitation.

Another possible study limitation concerns the exclusion of candidates with severe comorbidities. Although we will accept candidates with comorbid anxiety and other mild problems, for safety reasons, we will not include patients with severe symptoms that may require special attention, such as panic disorder, schizophrenia, alcohol abuse, etc. Excluding this population could result in a relatively heterogeneous group of patients, which is probably not representative of the population of Deprexis users.

Another conceivable limitation is participants who undergo psychotherapy or psychopharmacology during the online intervention process. In a group of 128 participants, it is expected that some will voluntarily seek different sources of treatment during the intervention, which can be considered a study limitation. On the other hand, setbacks such as significant losses and illness can happen randomly to all participants, both those who seek external help and those who do not, which can thus be considered a strength of the study design. Allowing participants access to TAU (psychiatry and clinical psychology services) could improve the external validity of our results. We can assume that an individual who is suffering from depression will seek help from different sources, either professional treatment or online information. Both scenarios will be considered and assessed in the final questionnaire.

Having a randomized control group with delayed access to Deprexis is among the study’s strengths. We are aware that the depressive symptoms of participants randomized to delayed intervention may decrease naturally with the passage of time, other professional or lay intervention, or significant life changes. Nevertheless, we assume that the potential symptom reduction in this group will make a reliable comparison to the group that gains immediate access to Deprexis.

In Brazil, research on easily accessible Internet-based intervention programs is at an early stage. Rigorous clinical trials on the effectiveness of such programs in Brazil are needed. To the best of our knowledge, this will be the first controlled trial to evaluate the effectiveness of an Internet-based program for depression in Brazil.

Acknowledgements

The authors would like to thank Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ), and Fundação Cultural Dom Manoel Pedro da Cunha Cintra (FDC) for supporting the students who assisted the research, as well as GAIA Group for letting us use Deprexis, and the Swiss National Science Foundation for supporting RTL and TB with a Scientific Exchange Grant (IZSEZ0_189796).

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Publication Dates

  • Publication in this collection
    09 Mar 2020
  • Date of issue
    2020

History

  • Received
    22 June 2019
  • Accepted
    22 Oct 2019
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