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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00919932
Other study ID # ACA-08-001-UPMC
Secondary ID
Status Completed
Phase N/A
First received June 11, 2009
Last updated January 18, 2016
Start date February 2009
Est. completion date January 2010

Study information

Verified date January 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary goal of the pilot is to test the feasibility and utility of using a text-messaging system to engage adolescents in improved homework adherence during cognitive-behavioral therapy (CBT) for major depressive disorder.


Description:

Adolescent major depressive disorder leads to recurrent episodes, increased rates of attempted and completed suicides, and persistent social impairment between episodes (Weissman et al 1999). Cognitive behavioral therapy (CBT) is an accepted first-line therapy for mild-moderate depression in adolescents. Integral to CBT is "homework" as it enhances mastery of newly learned coping strategies, facilitates generalization of skills to novel situations, increases self-efficacy, and ultimately reduces vulnerability to relapse (Detweiler et al 1999). Adherence to homework is a recognized problem in adults, and is similarly problematic in adolescents. One method of implementing CBT homework in a manner that is centric to current youth culture is through text messaging. By using a modern modality that many adolescents rely on for daily communication, there is the likelihood that they will find it more engaging than traditional modalities. Thus the potential that a text message system can help improve homework compliance in adolescents is significant, because improved homework adherence may ultimately be linked to improved clinical outcomes for these disorders with high rates of chronic morbidity and mortality.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria:

- major depressive disorder

- own a cellular phone with text messaging capabilities

Exclusion Criteria:

- history of psychosis

- history of mental retardation

- active suicidal ideation or intent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Paper and pen homework
Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks.
Device:
Text message system homework.
Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh American Academy of Child Adolescent Psychiatry.

Outcome

Type Measure Description Time frame Safety issue
Primary Therapy Homework Compliance: Percent Homework Completed Number of thought logs completed over the course of the 4 week trial. 1 month No
Secondary Exit Interview Verbal interview 1 month No
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