Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression

NCT01862913 | Completed

• 1 other identifier: FONDECYT Nº11121637
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

depression; adolescents

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Beck Depression Inventory (BDI) at 4 months

  Baseline and 4 months

Secondary Outcomes (4)

• Change from baseline in Children's Automatic Thought Questionnaire (CATS)

  Baseline, 4 months, and 6 months

• Change from baseline in Social Problem Solving Inventory-Revised Short Form (SPSI-RS)

  Baseline, 4 months, and 6 months

• Change from baseline in KIDSCREEN-27

  Baseline, 4 months, and 6 months

• Change from baseline in Beck Depression Inventory (BDI) at 6 months

  Baseline and 6 months

Study Arms (2)

Computer-assisted CBT

EXPERIMENTAL

* 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

Usual care treatment

ACTIVE COMPARATOR

\- 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

Interventions

Computer-assisted cognitive-behavioral therapy OTHER

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.

Computer-assisted CBT

Usual care treatment OTHER

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.

Usual care treatment

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

CESFAM Bernardo Leighton, CESFAM Cardenal Raúl Silva Henríquez, CESFAM Padre Manuel Villaseca, CESFAM San Gerónimo

Santiago, Chile

Location

Related Publications (2)

• Martinez V, Rojas G, Martinez P, Gaete J, Zitko P, Vohringer PA, Araya R. Computer-Assisted Cognitive-Behavioral Therapy to Treat Adolescents With Depression in Primary Health Care Centers in Santiago, Chile: A Randomized Controlled Trial. Front Psychiatry. 2019 Jul 30;10:552. doi: 10.3389/fpsyt.2019.00552. eCollection 2019.

  PMID: 31417440 DERIVED

• Martinez V, Martinez P, Vohringer PA, Araya R, Rojas G. Computer-assisted cognitive-behavioral therapy for adolescent depression in primary care clinics in Santiago, Chile (YPSA-M): study protocol for a randomized controlled trial. Trials. 2014 Aug 5;15:309. doi: 10.1186/1745-6215-15-309.

  PMID: 25091593 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Vania Martínez-Nahuel, Dr.med.

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 27, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

CL (1)