Do baseline participant characteristics impact the effectiveness of a mobile health intervention for depressive symptoms? A post-hoc subgroup analysis of the CONEMO trials

Claro, Heloísa Garcia; Menezes, Paulo Rossi; Fernandes, Ivan Filipe; Seward, Nadine; Miranda, Juan Jaime; Saidel, Maria Giovana Borges; Baquete, Aline Geovanna de Lima; Daley, Kate L.; Aschar, Suzana; Cruz, Daniela Vera; Castro, Hellen Carolina Martins; Rocha, Thais; Quayle, Julieta; Peters, Tim J.; Araya, Ricardo

doi:10.47626/1516-4446-2023-3172

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Brazilian Journal of Psychiatry

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ORIGINAL ARTICLE • Braz J Psychiatry 46 • 2024 • https://doi.org/10.47626/1516-4446-2023-3172 copy

Do baseline participant characteristics impact the effectiveness of a mobile health intervention for depressive symptoms? A post-hoc subgroup analysis of the CONEMO trials

Authorship SCIMAGO INSTITUTIONS RANKINGS

Objective:

To ascertain whether sociodemographic and health-related characteristics known from previous research to have a substantive impact on recovery from depression modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO).

Methods:

The CONEMO study consisted of two randomized controlled trials, one conducted in Lima, Peru, and one in São Paulo, Brazil. As a secondary trial plan analysis, mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest defined by characteristics measured before randomization – suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension – in both trials. We estimated interaction effects between the treatment group and these subgroup factors for the secondary outcomes using linear mixed regression models.

Results:

Increased effects of the CONEMO intervention on the primary outcome (reduction of at least 50% in depressive symptom scores at 3-month follow-up) were observed among older and wealthier participants in the Lima trial (p = 0.030 and p = 0.001, respectively).

Conclusion:

There was no evidence of such differential effects in São Paulo, and no evidence of impact of any other secondary outcomes in either trial.

Clinical trial registration:

NCT02846662 (São Paulo, Brazil – SP), NCT03026426 (Lima, Peru – LI). Funded by the U.S. National Institute of Mental Health (grant U19MH098780).

Digital technology; behavioral research; depression; randomized controlled trial; mobile applications

	São Paulo				Lima
	Digital intervention^† † Descriptive statistics for each subgroup by trial intervention (digital intervention and EUC).	EUC^† † Descriptive statistics for each subgroup by trial intervention (digital intervention and EUC).	Subgroup OR (95%CI)^‡ ‡ Estimated OR of the primary outcome for each subgroup with respective 95%CI from the relevant random-effects logistic regression model adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.	Digital intervention^† † Descriptive statistics for each subgroup by trial intervention (digital intervention and EUC).	EUC^† † Descriptive statistics for each subgroup by trial intervention (digital intervention and EUC).	OR (95%CI)^‡ ‡ Estimated OR of the primary outcome for each subgroup with respective 95%CI from the relevant random-effects logistic regression model adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.
Suicidal ideation
Never	300 (68)	300 (68)	1.54 (1.09 to 2.20)		120 (55)	124 (58)	2.64 (1.53 to 4.57)
More than 2 weeks ago	85 (19)	80 (18)	2.18 (1.05 to 4.54)		79 (36)	61 (28)	1.89 (0.93 to 3.87)
In the past 2 weeks	55 (13)	60 (14)	2.52 (1.03 to 6.15)	0.482	18 (8)	30 (14)	1.85 (0.51 to 6.69)	0.728
Ethnicity
Non-white	305 (69)	308 (70)	1.79 (1.26 to 2.56)
White	135 (31)	130 (30)	1.57 (0.91 to 2.72)	0.693
Age (years)
Younger than 60	264 (60)	269 (61)	1.62 (1.11 to 2.37)		104 (48)	100 (47)	1.39 (0.77 to 2.49)
60 or older	176 (40)	171 (39)	1.87 (1.16 to 3.00)	0.545	113 (52)	115 (53)	3.44 (1.93 to 6.11)	0.030
Gender
Female	378 (86)	383 (87)	1.56 (1.14 to 2.15)		186 (86)	166 (77)	2.07 (1.32 to 3.24)
Male	62 (14)	57 (13)	2.98 (1.32 to 6.70)	0.144	31 (14)	49 (23)	3.05 (1.15 to 8.07)	0.475
Technology
No mobile phone	82 (19)	83 (19)	3.38 (1.64 to 6.97)		29 (13)	29 (13)	2.47 (0.79 to 7.74)
No smartphone	111 (25)	103 (23)	1.09 (0.59 to 2.01)		81 (37)	76 (35)	2.02 (1.02 to 3.97)
Smartphone	247 (56)	254 (58)	1.67 (1.13 to 2.46)	0.060	107 (49)	110 (51)	2.36 (1.33 to 4.19)	0.926
Tobacco use
Nonsmoker	376 (85)	361 (82)	1.81 (1.31 to 2.50)		208 (96)	208 (97)	2.26 (1.49 to 3.42)
Smoker	64 (15)	79 (18)	1.30 (0.62 to 2.72)	0.424	9 (4)	7 (3)	2.16 (0.15 to 31.73)	0.975
Alcohol misuse
No risk	373 (85)	380 (86)	1.80 (1.30 to 2.48)		197 (91)	188 (87)	2.10 (1.36 to 3.22)
Risk	66 (15)	60 (14)	1.33 (0.61 to 2.88)	0.483	20 (9)	27 (13)	3.66 (1.01 to 13.29)	0.417
Missing	1 (1)	-	-		-	-	-
Chronic conditions
Hypertension	240 (55)	231 (53)	1.68 (1.13 to 2.51)		57 (26)	64 (30)	3.62 (1.64 to 8.01)
Diabetes	46 (10)	44 (10)	2.71 (1.03 to 7.11)		87 (40)	98 (46)	1.53 (0.82 to 2.86)
Both	154 (35)	165 (38)	1.54 (0.93 to 2.55)	0.588	73 (34)	53 (25)	2.53 (1.17 to 5.46)	0.231
Income
Less than two MW	304 (69)	293 (67)	1.83 (1.27 to 2.62)		152 (70)	148 (69)	1.44 (0.89 to 2.31)
Two or more MW	132 (30)	141 (32)	1.53 (0.90 to 2.58)	0.582	64 (29)	64 (30)	8.07 (3.38 to 19.26)	0.001
Missing	4 (1)	6 (1)	-		1 (1)	-	-

	São Paulo		Lima
BADS-SF^† † BADS-SF scores range from 0 to 54; higher scores represent a higher level of activation.	Difference in means (95%CI)^‡ ‡ Estimated difference in means for intervention for each subgroup with respective 95%CI, from the relevant random-effects logistic regression model adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.	Difference in means (95%CI)^‡ ‡ Estimated difference in means for intervention for each subgroup with respective 95%CI, from the relevant random-effects logistic regression model adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.
Suicidal ideation
Never	1.15 (-0.15 to 2.44)		2.41 (0.27 to 4.55)	0.371
More than 2 weeks ago	0.32 (-2.20 to 2.84)		4.89 (2.07 to 7.72)
In the past 2 weeks	1.47 (-1.48 to 4.41)	0.811	4.27 (-0.84 to 9.39)
Ethnicity
Non-white	0.94 (-0.36 to 2.23)		-
White	0.96 (-1.03 to 2.95)	0.985	-	-
Age (years)
Younger than 60	1.09 (-0.27 to 2.45)		4.45 (2.08 to 6.83)
60 or older	0.73 (-1.06 to 2.52)	0.755	2.99 (0.76 to 5.22)	0.380
Gender
Female	1.18 (0.01 to 2.35)		3.50 (1.70 to 5.29)
Male	-0.46 (-3.43 to 2.51)	0.313	4.28 (0.40 to 8.16)	0.719
Technology
No mobile phone	-0.12 (-2.69 to 2.44)		-0.55 (-5.08 to 3.98)
No smartphone	2.12 (-0.14 to 4.38)		4.21 (1.55 to 6.87)
Smartphone	0.86 (-0.55 to 2.28)	0.424	4.35 (2.07 to 6.64)	0.149
Tobacco use
Nonsmoker	1.15 (-0.04 to 2.33)		3.72 (2.07 to 5.38)
Smoker	-0.29 (-2.97 to 2.39)	0.336	2.12 (-6.45 to 10.69)	0.719
Alcohol misuse
No risk	0.79 (-0.39 to 1.96)		3.74 (2.02 to 5.45)
Risk	1.94 (-0.93 to 4.80)	0.466	2.70 (-2.38 to 7.78)	0.705
Chronic conditions
Hypertension	1.68 (0.20 to 3.17)		4.77 (1.71 to 7.83)
Diabetes	1.43 (-1.89 to 4.69)		2.64 (0.12 to 5.17)
Both	-0.10 (-1.90 to 1.70)	0.311	3.66 (0.66 to 6.67)	0.578
Income
Less than two MW	1.28 (-0.03 to 2.60)		3.38 (1.44 to 5.32)
Two or more MW	0.45 (-1.50 to 2.40)	0.489	4.39 (1.33 to 7.46)	0.584

	São Paulo		Lima
WHODAS-I^† † WHODAS-II scores range from 0 to 100; higher scores represent more severe disability.	Difference in means (95%CI)^‡ ‡ Estimated difference in means for intervention for each subgroup with respective 95%CI from the relevant random-effects logistic regression model, adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.	Difference in means (95%CI)^‡ ‡ Estimated difference in means for intervention for each subgroup with respective 95%CI from the relevant random-effects logistic regression model, adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.
Suicidal ideation
Never	-2.14 (-4.60 to 0.31)		-6.46 (-10.40 to -2.53)
More than 2 weeks ago	-2.00 (-6.83 to 2.82)		-5.04 (-10.29 to 0.21)
In the past 2 weeks	-8.66 (-14.38 to -2.92)	0.112	-12.37 (-21.80 to -2.94)	0.411
Ethnicity
Non-white	-1.58 (-4.07 to 0.90)
White	-5.89 (-9.70 to -2.08)	0.063
Age (years)
Younger than 60	-2.90 (-5.57 to -0.23)		-8.02 (-12.34 to -3.70)
60 or older	-2.75 (-6.13 to 0.63)	0.946	-5.70 (-9.81 to -1.59)	0.447
Gender
Female	-2.45 (-4.69 to -0.21)		-6.34 (-9.64 to -3.04)
Male	-5.39 (-11.05 to 0.27)	0.341^\|\| \|\| Estimated by a fixed-effects linear model.	-8.86 (-15.90 to -1.83)	0.525
Technology
No mobile phone	-3.28 (-8.15 to 1.60)		-1.31 (-9.56 to 6.95)
No smartphone	-2.98 (-7.29 to 1.33)		-10.55 (-15.42 to -5.67)
Smartphone	-2.61 (-5.31 to 0.08)	0.970	-5.60 (-9.78 to -1.42)	0.119
Tobacco use
Nonsmoker	-3.22 (-5.47 to -0.97)		-6.68 (-9.70 to -3.66)
Smoker	-0.85 (-6.13 to 4.42)	0.419	-10.85 (-26.98 to 5.29)	0.619
Alcohol misuse
No risk	-2.67 (-4.97 to -0.37)		-6.69 (-9.85 to -3.54)
Risk	-2.87 (-8.37 to 2.64)	0.948	-7.77 (-16.96 to 1.42)	0.829
Chronic conditions
Hypertension	-3.81 (-6.60 to -1.01)		-8.19 (-13.84 to -2.54)
Diabetes	-4.15 (-10.81 to 2.52)		-4.18 (-8.79 to 0.44)
Both	-1.08 (-4.55 to 2.39)	0.450	-9.22 (-14.75 to -3.70)	0.332
Income
Less than two MW	-2.87 (-5.39 to -0.34)		-6.70 (-10.27 to -3.12)
Two or more MW	-3.09 (-6.82 to 0.63)	0.922	-7.08 (-12.72 to -1.44)	0.911

	São Paulo		Lima
EQ-5D-3L^† † EQ-5D-3L scores range from 0 to 1; higher scores represent better quality of life.	Difference in means (95%CI)^‡ ‡ Estimated difference in means for intervention for each subgroup with respective 95%CIs from the relevant random-effects logistic regression model, adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.	Difference in means (95%CI)^‡ ‡ Estimated difference in means for intervention for each subgroup with respective 95%CIs from the relevant random-effects logistic regression model, adjusting for stratification and (for São Paulo) clustering by primary care unit as the unit of randomization.	Interaction p-value^§ § p-values derived for the interaction terms (intervention effect by baseline characteristic) by the likelihood ratio F-test in the random-effects regression model.
Suicidal ideation
Never	0.03 (0.01 to 0.06)		0.03 (-0.02 to 0.08)
More than 2 weeks ago	0.06 (0.01 to 0.10)		0.06 (-0.01 to 0.12)
In the past 2 weeks	0.02 (-0.03 to 0.08)	0.641	0.11 (-0.01 to 0.24)	0.465
Ethnicity
Non-white	0.03 (0.00 to 0.05)
White	0.04 (0.00 to 0.08)	0.620
Age (years)
Younger than 60	0.04 (0.01 to 0.07)		0.06 (0.01 to 0.12)
60 or older	0.02 (-0.02 to 0.05)	0.348	0.05 (-0.01 to 0.10)	0.685
Gender
Female	0.03 (0.01 to 0.05)		0.04 (-0.01 to 0.08)
Male	0.03 (-0.03 to 0.09)	0.983	0.13 (0.04 to 0.22)	0.064
Technology
No mobile phone	0.08 (0.03 to 0.13)		-0.08 (-0.19 to 0.02)
No smartphone	0.02 (-0.03 to 0.06)		0.10 (0.04 to 0.16)
Smartphone	0.02 (-0.00 to 0.05)	0.138	0.05 (-0.00 to 0.11)	0.015
Tobacco use
Nonsmoker	0.03 (0.01 to 0.05)		0.05 (0.02 to 0.09)
Smoker	0.04 (-0.02 to 0.09)	0.787	0.00 (-0.20 to 0.20)	0.604
Alcohol misuse
No risk	0.03 (0.01 to 0.06)		0.05 (0.01 to 0.09)
Risk	0.01 (-0.05 to 0.07)	0.430	0.06 (-0.06 to 0.18)	0.901
Chronic conditions
Hypertension	0.04 (0.02 to 0.07)		0.05 (-0.02 to 0.13)
Diabetes	0.05 (-0.02 to 0.12)		0.04 (-0.02 to 0.09)
Both	0.02 (-0.02 to 0.05)	0.498	0.07 (0.00 to 0.14)	0.773
Income
Less than 2 MW	0.04 (0.01 to 0.07)		0.05 (0.00 to 0.09)
Two or more MW	0.02 (-0.02 to 0.06)	0.322	0.06 (-0.01 to 0.13)	0.772

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[1] Correspondence: Heloísa Garcia Claro, Universidade Estadual de Campinas, Rua Tessália Vieira de Camargo, 126, sala 35, Cidade Universitária, CEP 13083-887, Campinas, SP, Brazil. E-mail: clarohg@unicamp.br