NCT00919932

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable major-depressive-disorder

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

February 15, 2016

Completed
Last Updated

February 15, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

June 11, 2009

Results QC Date

January 18, 2016

Last Update Submit

January 18, 2016

Conditions

Keywords

DepressionCBTTextingSMS

Outcome Measures

Primary Outcomes (1)

  • Therapy Homework Compliance: Percent Homework Completed

    Number of thought logs completed over the course of the 4 week trial.

    1 month

Secondary Outcomes (1)

  • Exit Interview

    1 month

Study Arms (2)

Paper and pen homework

ACTIVE COMPARATOR

Treatment as usual: therapy homework is completed by paper and pen.

Behavioral: Paper and pen homework

Text-message homework

EXPERIMENTAL

Experimental treatment: therapy homework is completed by text messaging.

Device: Text message system homework.

Interventions

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.

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 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.

Text-message homework

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • major depressive disorder
  • own a cellular phone with text messaging capabilities

You may not qualify if:

  • history of psychosis
  • history of mental retardation
  • active suicidal ideation or intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Paper

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Dr Han Liang
Organization
University of Pittsburgh

Study Officials

  • Han-chun Liang, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 15, 2016

Results First Posted

February 15, 2016

Record last verified: 2016-01