Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
Depression Other: Computer-assisted cognitive-behavioral therapy Other: Usual care treatment Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Change from baseline in Beck Depression Inventory (BDI) at 4 months [ Time Frame: Baseline and 4 months ]

Secondary Outcome Measures :
  1. Change from baseline in Children's Automatic Thought Questionnaire (CATS) [ Time Frame: Baseline, 4 months, and 6 months ]
  2. Change from baseline in Social Problem Solving Inventory-Revised Short Form (SPSI-RS) [ Time Frame: Baseline, 4 months, and 6 months ]
  3. Change from baseline in KIDSCREEN-27 [ Time Frame: Baseline, 4 months, and 6 months ]
    Health-related quality of life questionnaire

  4. Change from baseline in Beck Depression Inventory (BDI) at 6 months [ Time Frame: Baseline and 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Chile
CESFAM Bernardo Leighton, CESFAM Cardenal Raúl Silva Henríquez, CESFAM Padre Manuel Villaseca, CESFAM San Gerónimo
Santiago, Chile
Sponsors and Collaborators
University of Chile
Investigators
Layout table for investigator information
Principal Investigator: Vania Martínez-Nahuel, Dr.med. University of Chile

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Vania Martínez-Nahuel, Dr.med., University of Chile
ClinicalTrials.gov Identifier: NCT01862913     History of Changes
Other Study ID Numbers: FONDECYT Nº11121637
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Keywords provided by Vania Martínez-Nahuel, University of Chile:
depression
adolescents
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders