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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01083628
Other study ID # 68556-35551-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date April 2017

Study information

Verified date July 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to asses whether adding automated text messaging to group cognitive behavioral therapy for depression increases engagement which may lead to improved outcomes.


Description:

Background: Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy.

Objectives: The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, the investigators aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients.

Methods: Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week's content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date April 2017
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Participation in CBT group at San Francisco General Hospital

Exclusion Criteria:

- Active suicidality

- Active and severe psychosis

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group CBT for Depression with MoodText
Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Group CBT for Depression
Standard group CBT for depression using BRIGHT manual

Locations

Country Name City State
United States San Francisco General Hospital San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PHQ-9 Depression Symptoms The PHQ-9 (Patient Health Questionnaire - 9) is commonly used to screen for depression and to monitor progression of depressive symptoms over time. The scores represent the following depression severity: 0-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe, 20-27: severe. A score of 10 is often recommended as the cut-off score for diagnosing an episode of depression that may require treatment. 16 weeks
Secondary Attendance Number of sessions attended 16 weeks
Secondary Duration of Therapy Attended Number of weeks until patients dropped out of therapy 16 weeks
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