Depression
Conditions
Keywords
mhealth, depression, latinos, text messaging, CBT, SMS
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.
Interventions
BEHAVIORALGroup CBT for Depression with MoodText
Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
BEHAVIORALGroup CBT for Depression
Standard group CBT for depression using BRIGHT manual
Sponsors
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Participation in CBT group at San Francisco General Hospital
Exclusion criteria
* Active suicidality * Active and severe psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-9 Depression Symptoms | 16 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Attendance | 16 weeks | Number of sessions attended |
| Duration of Therapy Attended | 16 weeks | Number of weeks until patients dropped out of therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group CBT With Text Messaging Adjunct Group CBT for Depression with MoodText: Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis. | 45 |
| Group CBT for Depression Group CBT for Depression: Standard group CBT for depression using BRIGHT manual | 40 |
| Total | 85 |
Baseline characteristics
| Characteristic | Group CBT With Text Messaging Adjunct | Group CBT for Depression | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 40 Participants | 85 Participants |
| Age, Continuous | 51.71 years STANDARD_DEVIATION 11.55 | 51.83 years STANDARD_DEVIATION 11.73 | 51.75 years STANDARD_DEVIATION 11.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 40 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PHQ-9 | 13.36 units on a scale STANDARD_DEVIATION 5.96 | 13.13 units on a scale STANDARD_DEVIATION 4.99 | 13.25 units on a scale STANDARD_DEVIATION 5.68 |
| Region of Enrollment United States | 45 participants | 40 participants | 85 participants |
| Sex: Female, Male Female | 38 Participants | 29 Participants | 67 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 40 |
| serious Total, serious adverse events | 0 / 45 | 0 / 40 |
Outcome results
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.
Time frame: 16 weeks
Population: The number of participants analyzed in this intention-to-treat analyses represents the number of participants that provided PHQ-9 scores at the end of the study period, at 16 weeks. Because the PHQ-9 was filled in during psychotherapy sessions, this number is smaller than the original sample (n=44, n=38) due to patient drop-out of psychotherapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group CBT With Text Messaging Adjunct | PHQ-9 Depression Symptoms | 6 units on a scale | Standard Deviation 4.2 |
| Group CBT for Depression | PHQ-9 Depression Symptoms | 12.67 units on a scale | Standard Deviation 6.4 |
Secondary
Attendance
Number of sessions attended
Time frame: 16 weeks
Population: For the attendance analyses, 3 patients (1 in the intervention and 2 in the control) were excluded, because the study ended before these patients had been offered 16 sessions of psychotherapy.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Group CBT With Text Messaging Adjunct | Attendance | 6 sessions | Standard Deviation 2.3 |
| Group CBT for Depression | Attendance | 2.5 sessions | Standard Deviation 1.4 |
Secondary
Duration of Therapy Attended
Number of weeks until patients dropped out of therapy
Time frame: 16 weeks
Population: For the duration of therapy analyses, 3 patients (1 in the intervention and 2 in the control) were excluded, because the study ended before these patients had been offered 16 sessions of psychotherapy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group CBT With Text Messaging Adjunct | Duration of Therapy Attended | 13.5 weeks |
| Group CBT for Depression | Duration of Therapy Attended | 3 weeks |