Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression (YPSA-M)
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|ClinicalTrials.gov Identifier: NCT01862913|
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : November 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Other: Computer-assisted cognitive-behavioral therapy Other: Usual care treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression in Primary Care Clinics in Santiago, Chile (YPSA-M): A Randomized Controlled Trial|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Computer-assisted CBT
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.
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".
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.
- Change from baseline in Beck Depression Inventory (BDI) at 4 months [ Time Frame: Baseline and 4 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862913
|CESFAM Bernardo Leighton, CESFAM Cardenal Raúl Silva Henríquez, CESFAM Padre Manuel Villaseca, CESFAM San Gerónimo|
|Principal Investigator:||Vania Martínez-Nahuel, Dr.med.||University of Chile|