Edited by: Terence Dovey, Brunel University London, United Kingdom
Reviewed by: Milton L. Wainberg, Columbia University, United States; Christian Kieling, Federal University of Rio Grande do Sul, Brazil
*Correspondence: Graciela Rojas,
This article was submitted to Psychological Therapies, a section of the journal Frontiers in Psychiatry
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The pooled prevalence of major depressive disorders (MDD) among adolescents is estimated at 4% to 5% (
Studies have demonstrated that several effective interventions for addressing adolescent depression exist. Interpersonal and cognitive-behavioral psychotherapies (CBT) have shown to be efficacious and acceptable (
In addition to its effectiveness, patient preference may be an argument for the selection of psychotherapies as a promising treatment alternative for adolescent MDD (
The use of digital technologies as an alternative or complement to conventional mental health services has the potential to increase treatment access for underserved populations (
Computer-assisted CBT (cCBT) has been one of the most studied technology-assisted interventions for youth mental health (
Worldwide, evidence has highlighted the advantages of integrating child and adolescent mental health services into PHC (
During the past decades, important public mental health policies led to the integration of mental health into Chilean PHC (
In 2006, and after a major health care reform implemented within a social guarantee framework, depression was recognized as a national priority, ensuring financial protection and opportunity of access to the set of services included in the PTD-PHC for all people aged 15 and over (
Though promising, program evaluations have revealed that the effectiveness of the PTD-PHC is hindered by difficulties in making an accurate diagnosis of depression, and by low rates of treatment adherence (
This paper presents the results of a randomized controlled trial (RCT) of a brief therapist-guided cCBT intervention for adolescent depression in resource-constrained PHC settings in Santiago, the capital city of Chile. Further details about the intervention and the study design have been published elsewhere (
This was a multicenter, two-arm parallel-group, individually RCT with a 1:1 allocation ratio to either a nonpharmacological treatment intervention (therapist-guided cCBT) for adolescent depression in PHC or an enhanced usual care (EUC) intervention.
Puente Alto is a low-income municipality of Santiago, Chile, with a large adolescent population. Adolescents aged 15–19 years detected as suspected of having depression by professionals from four PHC centers in Puente Alto or nearby schools were invited to participate in the study. The adolescents who consented were asked to answer the Beck Depression Inventory (BDI) (
Before the start of recruitment, physicians in the four participating PHC centers received a special training session of 2 h from VM, aimed at assisting with the correct identification, diagnosis, and treatment of adolescent patients with depression, according to the Chilean Ministry of Health Clinical Guidelines for the Management of Depression (
Adolescents allocated to the experimental treatment received a therapist-guided cCBT intervention called YPSA-M (for “Yo pienso, siento y actúo—mejor”; in English: “I think, feel, and behave—better”) plus EUC—as described in the Chilean Ministry of Health Clinical Guidelines for the Management of Depression (
This experimental treatment was delivered through weekly 40-min-long face-to-face individual sessions for a period of 8 weeks by study therapists at the PHC centers. A freely available version of the YPSA-M software was installed in the consulting room computers, with access restricted to study therapists (materials available upon request from the corresponding author). During sessions, therapists used the YPSA-M to deliver the intervention, which guided depressed adolescents on the use of the software and encouraged them to complete exercises and review personal cards with key learning points handed out after each session.
Study therapists were psychologists experienced in the treatment of depressed adolescents and with a basic understanding of CBT concepts. They received 12 h of training on the use of the intervention and were supervised by VM once a month and upon request (1 h). There was provided guidance to therapists on a wide range of clinical scenarios (e.g., how to proceed if the adolescent came to the session in a crisis situation, how to incorporate parents/guardians in the sessions).
Sessions were audio-recorded, and fidelity assessments were conducted to evaluate how closely the study therapists adhered to the cCBT intervention. The compliance was assessed using a verification checklist in a random sample of 10%.
Between sessions, the study coordinator contacted the participants to remind them of their appointments.
Adolescents allocated to the comparator treatment received an EUC intervention provided by trained PHC psychologists in the four participating PHC centers. Psychologists received a special training session (2 h) from VM, aimed at assisting with the correct identification, diagnosis, and treatment of adolescent patients with depression, according to the Chilean Ministry of Health Clinical Guidelines for the Management of Depression (
The primary outcome was the BDI score at 4 months post-randomization. The BDI is a well-established, psychometrically sound, 21-item self-report questionnaire used to assess key symptoms of depression (
The secondary outcomes were defined as follows: a) the 10-item “personal failure” subscale (score range 0–40) of the Children’s Automatic Thoughts Scale (CATS) (
It was anticipated that the therapist-guided cCBT intervention would produce a clinically meaningful improvement (remission, BDI score <10) in 60% of adolescents, and that only 40% of those in the comparator would reach this level of improvement in 4 months post-randomization. A difference of 20% would be regarded as clinically meaningful. To achieve a two-sided alpha coefficient of 5% and a statistical power of 80%, at least 97 adolescents were needed in each group to detect this difference, or 108 subjects per group, allowing for 10% attrition (
Randomization was balanced using a block size of four and stratified by sex and severity of depression symptoms (mild, moderate, and severe), according to BDI score. Randomization was generated using web-based random allocation algorithms. Sequentially numbered, opaque, sealed envelopes were sent to each PHC center. VM, MH, and FB enrolled participants and opened sealed envelopes to determine treatment assignments. The outcomes assessors were not part of the baseline assessment and were blinded to treatment assignments.
The Consolidated Standards of Reporting Trials (CONSORT) statement was followed for reporting the results of this study (
This study was registered as a clinical trial at clinicaltrials.gov, using the clinical trial unique identifier: NCT01862913; and URL:
A total of 311 adolescents were assessed for eligibility at the four PHC centers, but 90 did not meet eligibility criteria, and 5 did not consent to participate. Therefore, 216 adolescents were randomly allocated to either the therapist-guided cCBT intervention (experimental treatment group) or the EUC intervention (comparator treatment group). There were 202 (94%) participants who provided data for the primary outcome (4-month post-randomization BDI score), 93% in the experimental treatment
CONSORT flow diagram. Flow of participants.
Characteristics of participants at baseline by trial arm.
Characteristics | Therapist-guided cCBT intervention |
Enhanced usual care intervention |
---|---|---|
Female sex, no. (%) | 82 (75.9) | 83 (76.9) |
Age, mean (SD), y | 16.2 (1.1) | 16.3 (1.1) |
Years of schooling, mean (SD), y | 9.0 (1.3) | 9.4 (1.4) |
Living with, no. (%) | ||
Both parents | 53 (49.07) | 53 (49.07) |
One of the parents | 49 (45.37) | 47 (43.52) |
None of the parents | 6 (5.56) | 8 (7.41) |
Socioeconomic level, no. (%) | ||
Low | 47 (43.52) | 47 (43.52) |
Medium | 60 (55.56) | 59 (54.63) |
High | 1 (0.92) | 2 (1.85) |
Depressive symptom score, mean (SD) | 25.7 (8.5) | 25.5 (7.9) |
Depressive symptoms severity, no. (%) | ||
Mild | 28 (25.93) | 25 (23.15) |
Moderate | 44 (40.74) | 43 (39.81) |
Severe | 36 (33.33) | 40 (37.04) |
Personal history of mental health assistance, no. (%) | 53 (49.07) | 57 (52.78) |
Parental history of depression, no. (%) | 43 (39.82) | 43 (39.82) |
Depressive symptom score and severity according to Beck Depression Inventory.
Statistically significant (adjusted) differences were found in the mean BDI scores between the two groups at 4 months post-randomization (-3.75, 95% CI -6.23 to -1.28, P = 0.003), with a small-to-medium effect size (
BDI scores at 4 and 6 months post-randomization.
Analysis | Mean BDI score |
|
||
---|---|---|---|---|
Therapist-guided cCBT intervention | Enhanced usual care intervention | Adjusted difference in means (95% CI) |
||
4 months | 13.2 (9.4) | 17.1 (10.2) | –3.75 (-6.23 to -1.28) | 0.003 |
No. (primary outcome) | 100 | 102 | ||
6 months | 12.0 (9.2) | 14.7 (9.9) | –2.31 (-4.89 to 0.27) | 0.078 |
No. | 87 | 91 |
Data are mean (standard deviation), unless otherwise specified.
BDI score adjusted for sex and baseline BDI score.
Adjusted differences in the mean BDI scores between the two groups at 6 months post-randomization favored the experimental treatment group, although this marginally failed to reach statistical significance -2.31 (95% CI -4.89 to 0.27, P = 0.078), and had a small (and non-significant) effect size (
Analysis of secondary outcomes at 4 and 6 months post-randomization.
Analysis | Therapist-guided cCBT intervention | Enhanced usual care intervention | Adjusted difference in means (95% CI) |
|
||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | 4 mo | 6 mo | Baseline | 4 mo | 6 mo | 4 mo | 6 mo | 4 mo | 6 mo | |
CATS | 19.5 (8.6) | 9.8 (8.4) | 9.5 (9.0) | 20.5 (9.5) | 14.0 (9.8) | 11.9 (9.6) | –3.76 | –1.81 | 0.002 | 0.168 |
(n = 108) | (n = 94) | (n = 80) | (n = 108) | (n = 95) | (n = 82) | (–6.15 to -1.37) | (–4.40 to 0.77) | |||
SPSI-RS | 9.5 (2.6) | 11.6 (3.0) | 11.5 (3.1) | 9.2 (2.4) | 10.5 (2.7) | 10.3 (2.7) | 1.01 | 1.00 | 0.009 | 0.025 |
(n = 108) | (n = 90) | (n = 80) | (n = 107) | (n = 92) | (n = 79) | (0.26 to 1.77) | (0.13 to 1.89) | |||
Physical well-being | 30.7 (7.5) | 36.3 (9.0) | 36.2 (7.8) | 30.0 (7.1) | 33.8 (8.2) | 34.9 (9.10) | 2.67 | 1.37 | 0.024 | 0.292 |
(n = 108) | (n = 93) | (n = 78) | (n = 108) | (n = 92) | (n = 82) | (0.35 to 4.99) | –1.19 to 3.94) | |||
Psychological well-being | 30.9 (6.7) | 42.9 (12.7) | 42.2 (12.7) | 29.6 (6.7) | 38.6 (10.3) | 39.6 (10.5) | 4.02 | 2.51 | 0.018 | 0.159 |
(n = 107) | (n = 94) | (n = 78) | (108) | (n = 93) | (n = 83) | (0.70 to 7.34) | (–1.00 to 6.02) | |||
Autonomy and parent relation | 40.3 (8.9) | 43.6 (12.0) | 43.8 (12.1) | 37.8 (10.1) | 42.0 (9.6) | 41.3 (10.4) | 0.52 | –0.28 | 0.677 | 0.842 |
(n = 108) | (n = 94) | (n = 78) | (n = 108) | (n = 92) | (n = 82) | (–1.93 to 2.96) | (–3.10 to 2.53) | |||
Peers and social support | 42.2 (13.5) | 46.5 (13.3) | 46.7 (15.5) | 43.0 (13.1) | 47.1 (12.5) | 47.6 (13.5) | –0.68 | –0.04 | 0.684 | 0.983 |
(n = 108) | (n = 94) | (n = 78) | (n = 108) | (n = 94) | (n = 83) | (–3.97 to 2.61) | (–4.11 to 4.02) | |||
School environment | 36.6 (9.1) | 44.6 (10.4) | 47.0 (10.5) | 36.8 (8.9) | 43.5 (11.2) | 42.7 (11.8) | 2.13 | 4.61 | 0.164 | 0.009 |
(n = 105) | (n = 83) | (n = 66) | (n = 104) | (n = 83) | (n = 69) | (–0.88 to 5.15) | (1.20 to 8.02) | |||
General HRQoL Index | 33.8 (6.1) | 41.9 (10.1) | 41.6 (9.6) | 32.3 (6.7) | 39.3 (7.6) | 39.8 (7.9) | 2.56 | 1.43 | 0.053 | 0.309 |
(n = 104) | (n = 83) | (n = 66) | (n = 104) | (n = 83) | (n = 69) | (–0.03 to 5.15) | (–1.35 to 4.22) |
Data are mean (standard deviation), unless otherwise specified.
Outcome adjusted for sex and baseline scores.
The mean number of therapist-guided cCBT intervention sessions attended was 5.38 (SD 2.7), and treatment compliance was found in 63.9% of the patients. Adolescents in the experimental treatment group were significantly more satisfied with treatment, with the PHC centers’ facilities, with the psychological care received, and with non-professional staff than those in the comparator treatment group. There were no differences between both arms in terms of satisfaction with the medical care received (see
Assessments of the fidelity of the experimental treatment delivery revealed that sessions lasted a mean of 30.6 minutes (SD 9.7, range 16 to 59), and that the therapists delivered 94.7% of the proposed activities with good quality (SD 8.4, range 70 to 100).
Satisfaction with treatment at 6 months post-randomization.
No. (%) | |||
---|---|---|---|
Therapist-guided cCBT intervention |
Enhanced usual care intervention |
|
|
Satisfaction with treatment, [n], mean, (SD) | [n = 84] 6.1 (1.1) | [n = 86] 5.4 (1.6) | 0.002 |
Satisfaction with facilities, [n], mean, (SD) | [n = 82] 6.1 (0.1) | [n = 89] 5.6 (0.2) | 0.012 |
Satisfaction with medical care, [n], mean, (SD) | [n = 81] 6.6 (0.9) | [n = 89] 6.4 (0.1) | 0.116 |
Satisfaction with psychological care, [n], mean, (SD) | [n = 81] 6.8 (0.1) | [n = 86] 6.2 (0.2) | 0.003 |
Satisfaction with non-professional staff treatment, [n], mean, (SD) | [n = 82] 6.5 (0.1) | [n = 89] 6.0 (0.1) | 0.010 |
[n] = Number of individuals when it does not match the initial number of 108 subjects per group.
There was no evidence that the effect of the intervention on the BDI score at 4 months was modified by baseline depression severity (mild symptomatology was used as reference group). For moderate symptomatology, the interaction coefficient was -1.49 (95% CI, −7.98 to 5.00; P = .651), and for severe symptomatology, the interaction coefficient was -3.83 (95% CI, -10.47 to 2.81; P = 0.257). There was no evidence that the effect of the intervention on the BDI score at 6 months was modified by baseline depression severity (mild symptomatology was used as reference). For moderate symptomatology, the interaction coefficient was -1.24 (95% CI, −8.21 to 5.73; P = .7261), and for severe symptomatology, the interaction coefficient was -2.18 (95% CI, -9.25 to 4.90; P = 0.544). Therefore, the interactions terms were not included in the analyses of the primary outcome.
Remission rates were significantly higher in the experimental treatment group at 4 months post-randomization [40.0%
A brief therapist-guided cCBT intervention was found to be superior to the EUC for adolescent depression with respect to measures of depressive symptoms, dysfunctional thoughts, social problem-solving abilities, perception of school environment, physical and psychological well-being, general HRQoL, and remission rates of depression. Moreover, adolescents receiving this experimental treatment were more satisfied with the psychological intervention,
This study is the first to report evidence on the efficacy of a brief therapist-guided cCBT intervention for adolescent depression in Latin America. As this trial was carried out in real-life PHC settings serving an urban poor population in one of the largest cities of the Region, it valuably contributes to reducing the gap in scientific knowledge regarding the treatment of depression in vulnerable groups receiving mental health care attention in resource-constrained settings (
A recent meta-analysis on the effects of integrated medical-behavioral care (i.e., provision of mental health care in PHC) for child and adolescent mental health outcomes revealed a medium and significant effect size for improved youth outcomes (
The feasibility and acceptability of technology-assisted interventions (whether computer-based or not) for depression are well established (
For example, in the pilot RCT by Stallard et al. (
The promising results of this RCT must be considered along with its limitations. First, as the sample size was calculated to detect differences at 4 months post-randomization, it may have lacked enough statistical power to detect potentially meaningful effects at 6 months post-randomization. Second, although a RCT is often referred to as the gold standard of clinical research, the non-blinding of participants (i.e., patients and providers) along with the use of patient self-reported outcomes may have increased the risk of bias and produced an over estimation of the potential benefits of the intervention. Third, in addition to the high non-compliance rate among the patients in the experimental treatment group, weekly sessions had to be rescheduled due to barriers in PHC centers or participants (e.g., illness, holidays, study obligations), producing alterations in the periodicity of treatment. Fourth, as currently the Chilean Ministry of Health Clinical Guidelines for the Management of Depression do not specify the number of sessions for psychosocial interventions, nor its periodicity, adherence to guidelines in the comparator treatment group was not assessed. Fifth, the use of psychologists may prevent generalizability to other low-resource settings. It is worth clarifying that, in Chile, psychologists are in charge to provide psychotherapy in PHC centers. However, many of them do not have specific training or certification in psychotherapy. Sixth, data such as indicated dose or adherence to the pharmacological treatment was not collected. However, in both groups, the pharmacological treatment was in charge of the same medical doctors of the PHC centers, and there were no differences in the proportion of participants who received medication. Finally, the therapist-guided cCBT intervention relied almost exclusively on the use of patient-level (i.e., individual) strategies; this may have been one of the reasons for the lack of an apparent effect on the HRQoL subscales of peers and social support, and parent relationships. Thus, a future therapist-guided cCBT intervention must consider these limitations, having sufficient statistical power to detect significant differences at the last follow-up assessment, including clinician-reported outcomes, testing new strategies to improve adherence to and periodicity of treatments, and including the use of therapeutic strategies at the family or school level.
The feasibility, acceptability, and proven efficacy of a brief therapist-guided cCBT intervention described in this study have relevant implications for the treatment of adolescent depression in PHC settings. Most depressed adolescents who require care do not obtain it, and those who manage to access help often do not show clinical improvements, possibly because the psychological treatment received is not sufficiently tailored to their needs. Among other strengths, the use of cCBT helps to ensure an improved fidelity with evidence-based treatments. Improvements were found for most of the therapeutic skills that were taught, an outcome that was not found with a universal intervention of a similar program (
A brief therapist-guided cCBT eight-session intervention improved behavioral health outcomes of depressed adolescents treated in PHC centers of a Latin American developing country. However, differences of between groups were not sustained over time. This trial importantly contributes to reduce the gap in scientific knowledge with respect to treatment of depression in vulnerable groups of the population and provides one of the first examples of a technology-assisted intervention to integrate adolescent depression treatment into PHC. Future research should focus on exploring new strategies to sustain and increase response, especially among adolescents with severe depression and on investigating the cost-effectiveness of this intervention before advocating for a major scale up in PHC services.
The study was approved by the Ethic Committee of Human Research of the Faculty of Medicine of Universidad de Chile (project number 032-2012). Written informed consent was obtained directly from each participant over 18 years of age, and written informed assent and consent was taken from the underage participants and their parents (or guardians), respectively.
VM was the principal investigator of this study. VM, GR, and RA conceived the study and were involved in managing and advising the project. PM and PV contributed to the development of the project. JG and PZ performed the statistical analyses. All authors contributed to the drafting of this paper and approved the final manuscript.
This project was funded by the Chilean National Fund for Scientific and Technological Development, FONDECYT (project number 11121637), Millennium Science Initiative of the Ministry of Economy, Development and Tourism, grant “Millennium Nucleus to Improve the Mental Health of Adolescents and Youths, Imhay,” and the Innovation Fund for Competitiveness [Fondo de Innovación para la Competitividad, FIC], part of the Chilean Ministry of Economy, Development, and Tourism, through the Millennium Scientific Initiative, Project IS130005. The funding sources had no influence on study design; the collection, analysis, and interpretation of data; the writing of the report; or the decision to submit the manuscript for publication.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
We would like to thank our funding sources, which include: The National Commission for Scientific and Technological Research, and the Millennium Science Initiative. Also, we would like to thank the Health Area of the Municipal Corporation of Puente Alto, and the staff of the participating primary health care centers and the nearby schools, and the users who contributed to this project. In addition, thanks to the support of the project Network for the development of e-mental health, U-REDES-C_2018_07.