- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01083628
Text Messaging and Cognitive Behavioral Therapy for Depression (HealthySMS)
Automated Text Messaging to Increase Engagement in Cognitive Behavioral Therapy (CBT) for Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94110
- San Francisco General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participation in CBT group at San Francisco General Hospital
Exclusion Criteria:
- Active suicidality
- Active and severe psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group CBT for Depression with MoodText'
Group cognitive behavioral therapy utilizing the BRIGHT manual for depression along with automated text messaging for mood monitoring and reminder of session content
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Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Other Names:
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Active Comparator: Group CBT for Depression
Standard group cognitive behavioral therapy utilizing the BRIGHT manual for depression
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Standard group CBT for depression using BRIGHT manual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHQ-9 Depression Symptoms
Time Frame: 16 weeks
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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.
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance
Time Frame: 16 weeks
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Number of sessions attended
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16 weeks
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Duration of Therapy Attended
Time Frame: 16 weeks
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Number of weeks until patients dropped out of therapy
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16 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Adrian Aguilera, Ph.D., University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 68556-35551-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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