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Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression (YPSA-M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01862913
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Vania Martínez-Nahuel, University of Chile

Tracking Information
First Submitted Date  ICMJE May 20, 2013
First Posted Date  ICMJE May 27, 2013
Last Update Posted Date November 10, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
Change from baseline in Beck Depression Inventory (BDI) at 4 months [ Time Frame: Baseline and 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
Change from baseline in Beck Depression Inventory (BDI) at 3 months [ Time Frame: Baseline and 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
  • Change from baseline in Children's Automatic Thought Questionnaire (CATS) [ Time Frame: Baseline, 4 months, and 6 months ]
  • Change from baseline in Social Problem Solving Inventory-Revised Short Form (SPSI-RS) [ Time Frame: Baseline, 4 months, and 6 months ]
  • Change from baseline in KIDSCREEN-27 [ Time Frame: Baseline, 4 months, and 6 months ]
    Health-related quality of life questionnaire
  • Change from baseline in Beck Depression Inventory (BDI) at 6 months [ Time Frame: Baseline and 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
  • Change from baseline in Children's Automatic Thought Questionnaire (CATS) [ Time Frame: Baseline, 3 months, and 6 months ]
  • Change from baseline in Social Problem Solving Inventory-Revised Short Form (SPSI-RS) [ Time Frame: Baseline, 3 months, and 6 months ]
  • Change from baseline in KIDSCREEN-27 [ Time Frame: Baseline, 3 months, and 6 months ]
    Health-related quality of life questionnaire
  • Change from baseline in Beck Depression Inventory (BDI) at 6 months [ Time Frame: Baseline and 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression
Official Title  ICMJE Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression in Primary Care Clinics in Santiago, Chile (YPSA-M): A Randomized Controlled Trial
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Other: Computer-assisted cognitive-behavioral therapy
    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.
  • Other: Usual care treatment
    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.
Study Arms  ICMJE
  • Experimental: Computer-assisted CBT
    • Usual medical treatment in accordance with a decision algorithm based on the "Clinical Guidelines for the Treatment of Depression of the Ministry of Health of Chile".
    • Eight sessions of a computer-assisted cognitive-behavioral therapy. Trained psychologists administer this program in face to face meetings.
    Intervention: Other: Computer-assisted cognitive-behavioral therapy
  • Active Comparator: Usual care treatment
    - Usual psychological and medical treatment in accordance with a decision algorithm based on the "Clinical Guidelines for the Treatment of Depression of the Ministry of Health of Chile".
    Intervention: Other: Usual care treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2013)
216
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Beck Depression Inventory > o = 10
  • Meets diagnostic criteria of a depressive disorder according Kiddie Sads Present and Lifetime Version interview (K-SADS-PL)
  • Parent or caregiver giving informed consent and adolescent giving informed assent

Exclusion Criteria:

  • Suicidal risk requiring in-patient care
  • Bipolar Disorder
  • Current substance dependence
  • Current alcohol dependence
  • Current psychosis
  • Low intellectual abilities
  • Current treatment with antidepressant and/or psychotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01862913
Other Study ID Numbers  ICMJE FONDECYT Nº11121637
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vania Martínez-Nahuel, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vania Martínez-Nahuel, Dr.med. University of Chile
PRS Account University of Chile
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP