Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Background: Most adolescents suffering depression are treated in primary care clinics.
      Cognitive-behavior therapy (CBT) is effective in the treatment of adolescent depression. The
      availability of appropriately trained CBT therapist may be limited, especially in primary
      care clinics. One way to increase the availability of CBT is to use computer-assisted CBT
      (c-CBT). It can be effective in the treatment of adults, although the outcomes in adolescents
      remain unclear.

      Purpose: The purpose of this study is to determine whether a computer-assisted
      cognitive-behavioral therapy is effective for the treatment of depression in adolescents
      between 15 and 19 years of age in 4 primary care clinics in Santiago, Chile.

      Study design: A two-arm single-blind (outcomes assessor) randomized controlled trial will be
      carried out with 216 adolescents. The efficacy, the adherence, and acceptability of the
      computerized-assisted cognitive behavioral therapy will be evaluated.
    

Detailed description: 
      This is a two-arm, single-blind (blinded only to outcome assessor), individually randomized
      controlled trial, which will compare the efficacy of computer-assisted CBT versus usual
      treatment for depression in adolescents in primary care clinics in Santiago, Chile.

      General aim To carry out a randomized controlled trial to compare the efficacy of a
      computer-assisted CBT intervention versus usual care to treat depression in adolescents in
      primary care clinics in Santiago, Chile.

      Specific aims

        1. To compare the level of depressive symptoms of adolescents suffering depression treated
           with computer-assisted CBT versus usual care in primary care clinics.

        2. To compare the level of dysfunctional thoughts, strategies for solving problems, and
           health-related quality of life (HRQoL) of adolescents suffering depression treated with
           computer-assisted CBT versus usual care in primary care clinics.

        3. To compare adolescents' adherence to computer-assisted CBT versus usual care in primary
           care clinics.

        4. To compare adolescents' satisfaction with computer-assisted CBT versus usual care in
           primary care clinics.

      Hypotheses

        1. Adolescents receiving the intervention will achieve lower scores (difference in mean of
           at least 0.4 standard deviations) in the depression questionnaire than those receiving
           the usual care, four months after randomization.

        2. Adolescents receiving the intervention would have fewer dysfunctional thoughts than
           those receiving the usual care, four months after randomization.

        3. Adolescents receiving the intervention would be better at solving problems than those
           receiving the usual care, four months after randomization.

        4. Adolescents receiving the intervention would have better HRQoL than those receiving the
           usual care, four months after randomization.

        5. Symptomatic improvements achieved at four months after randomization will be maintained
           at six months after randomization.

      Setting and population Adolescents between 15 and 19 years of age attending four primary care
      clinics located in Puente Alto, a low-income municipality of Santiago, Chile, with a large
      adolescent population.

      Training of primary care center professionals Before the start of recruitment, professionals
      in the four participating primary care centers will receive a special training session from
      the principal investigator to assist with the correct identification, diagnosis, and
      treatment of patients with depression, according to the AUGE Clinical Guidelines for
      Depression. There will also be a refresher session 6 months after the start of recruitment.

      Recruitment Adolescents eligible for the study will be identified by health professionals of
      the four primary care clinics, as well as by psychologists and counselors of nearby schools,
      who will be informed of the study, trained to identify potential cases of depression among
      their students, and instructed to refer any adolescent who seems to have depression symptoms
      to the primary care clinics for further evaluation and possible participation in the study,
      according to inclusion and exclusion criteria.

      Group assignment Those adolescents who at baseline assessment meet the inclusion criteria and
      do not meet the exclusion criteria will be randomly assigned to the intervention arm or to
      the control arm. Blocked (size of four), stratified randomization will be used.
      Stratification will be implemented regarding sex and severity of depression (mild, moderate,
      and severe) according to BDI score. Randomization will be generated using web-based random
      allocation algorithms. Allocation concealment will be carried out by keeping treatment
      assignment in numbered sealed envelopes in a central place; the envelopes will be opened by
      individuals who do not participate in the recruitment process.

      Data collection All participants will be assessed at baseline and at four and six months
      after randomization. The instruments that will be used are all self-report questionnaires,
      which will be completed on paper by the participants. Trained psychologists who are blind to
      the group assignments will be present to assist the adolescents if necessary.

      Data management After the participants have completed the questionnaires, the data will
      entered into a secure platform, without identifying information (each participant will be
      assigned an ID number). The original copies of the instruments will be filed and stored,
      under lock and key, in the principal investigator's office, along with the list linking the
      participants' names and ID numbers. Only two research assistants, in charge of data entry,
      and the statistician will have access to the database.

      Data analysis Data and presentation of the results will be in accordance with CONSORT
      guidelines for randomized clinical trials, with the primary comparative analysis being
      conducted on an intention-to-treat basis. Initially, we will conduct descriptive analysis to
      assess the balance between the two groups. The primary analysis will employ multivariable
      linear regression to investigate differences in mean symptom scores (primary outcome measure)
      between groups at four months after randomization, adjusting for baseline outcome variable if
      imbalances are identified. Sensitivity analysis making different assumptions will be
      conducted to investigate the potential effects of missing data. Similar analyses will be
      conducted for the secondary outcome measures.
    

Intervention name(s): Computer-assisted cognitive-behavioral therapy; Usual care treatment
Intervention type(s): Other; Other
Intervention description(s): The intervention arm will receive eight sessions of computer-assisted CBT plus usual medical treatment, as described in the AUGE Clinical Guidelines for Depression. Computer-assisted CBT sessions will be delivered on a weekly basis and assisted by trained psychologists in face-to-face meetings. The program is called 'Yo pienso, siento y actúo mejor' (YPSA-M); in English, 'I think, feel, and behave better'. Topics covered in the program will include information on symptoms and causes of depression, treatment options, problem-solving techniques and other cognitive-orientated strategies to challenge negative thoughts.; The control arm will receive treatment as usual from the primary care clinics. The professionals in the primary care centers will be instructed to follow the AUGE Clinical Guidelines for Depression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; adolescents