Text Messaging and Cognitive Behavioral Therapy for Depression (HealthySMS)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group CBT for Depression with MoodText
Group CBT for Depression
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring mhealth, depression, latinos, text messaging, CBT, SMS
Eligibility Criteria
Inclusion Criteria:
- Participation in CBT group at San Francisco General Hospital
Exclusion Criteria:
- Active suicidality
- Active and severe psychosis
Sites / Locations
- San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group CBT for Depression with MoodText'
Group CBT for Depression
Arm Description
Group cognitive behavioral therapy utilizing the BRIGHT manual for depression along with automated text messaging for mood monitoring and reminder of session content
Standard group cognitive behavioral therapy utilizing the BRIGHT manual for depression
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Attendance
Number of sessions attended
Duration of Therapy Attended
Number of weeks until patients dropped out of therapy
Full Information
NCT ID
NCT01083628
First Posted
February 19, 2010
Last Updated
July 2, 2019
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01083628
Brief Title
Text Messaging and Cognitive Behavioral Therapy for Depression
Acronym
HealthySMS
Official Title
Automated Text Messaging to Increase Engagement in Cognitive Behavioral Therapy (CBT) for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
mhealth, depression, latinos, text messaging, CBT, SMS
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group CBT for Depression with MoodText'
Arm Type
Experimental
Arm Description
Group cognitive behavioral therapy utilizing the BRIGHT manual for depression along with automated text messaging for mood monitoring and reminder of session content
Arm Title
Group CBT for Depression
Arm Type
Active Comparator
Arm Description
Standard group cognitive behavioral therapy utilizing the BRIGHT manual for depression
Intervention Type
Behavioral
Intervention Name(s)
Group CBT for Depression with MoodText
Other Intervention Name(s)
Group CBT for Depression with HealthySMS
Intervention Description
Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Intervention Type
Behavioral
Intervention Name(s)
Group CBT for Depression
Intervention Description
Standard group CBT for depression using BRIGHT manual
Primary Outcome Measure Information:
Title
PHQ-9 Depression Symptoms
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Attendance
Description
Number of sessions attended
Time Frame
16 weeks
Title
Duration of Therapy Attended
Description
Number of weeks until patients dropped out of therapy
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participation in CBT group at San Francisco General Hospital
Exclusion Criteria:
Active suicidality
Active and severe psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Aguilera, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25373390
Citation
Aguilera A, Berridge C. Qualitative feedback from a text messaging intervention for depression: benefits, drawbacks, and cultural differences. JMIR Mhealth Uhealth. 2014 Nov 5;2(4):e46. doi: 10.2196/mhealth.3660.
Results Reference
derived
Learn more about this trial
Text Messaging and Cognitive Behavioral Therapy for Depression
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