DepressionHealthySMSNCT01083628
Text Messaging and Cognitive Behavioral Therapy for Depression
A study testing Group CBT for Depression with MoodText and Group CBT for Depression in people with Depression, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Depression
- What is being tested?
- Group CBT for Depression with MoodText and Group CBT for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in CBT group at San Francisco General Hospital
Who cannot join
- Active suicidality
- Active and severe psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Automated Text Messaging to Increase Engagement in Cognitive Behavioral Therapy (CBT) for Depression
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Group CBT for Depression with MoodText, Group CBT for Depression
- Keywords
- mhealth, depression, latinos, text messaging, CBT, SMS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CBT for Depression with MoodTextBehavioural
Also called Group CBT for Depression with HealthySMS
Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Group CBT for DepressionBehavioural
Standard group CBT for depression using BRIGHT manual
| Study group | Role | What they receive |
|---|---|---|
| Group CBT for Depression with MoodText' | Experimental | Group cognitive behavioral therapy utilizing the BRIGHT manual for depression along with automated text messaging for mood monitoring and reminder of session content Receives: Behavioral: Group CBT for Depression with MoodText |
| Group CBT for Depression | Active comparator | Standard group cognitive behavioral therapy utilizing the BRIGHT manual for depression Receives: Behavioral: Group CBT for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (2)
Attendance
Number of sessions attended
Measured: 16 weeks
Duration of Therapy Attended
Number of weeks until patients dropped out of therapy
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Aguilera, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083628
- Sponsor's protocol ID
- 68556-35551-01
- Acronym
- HealthySMS
- Status last verified
- Jul 2019
- First submitted
- 19 Feb 2010
- Last updated
- 12 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25373390
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Text Messaging to Increase Engagement in Cognitive Behavioral Therapy (CBT) for Depression
- ClinicalTrials.gov ID
- NCT01083628
- Acronym / sponsor ID
- HealthySMS / 68556-35551-01
- Conditions
- Depression
- Keywords
- mhealth, depression, latinos, text messaging, CBT, SMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CBT for Depression with MoodText' | Experimental | Behavioral: Group CBT for Depression with MoodTextGroup cognitive behavioral therapy utilizing the BRIGHT manual for depression along with automated text messaging for mood monitoring and reminder of session content |
| Group CBT for Depression | Active comparator | Behavioral: Group CBT for DepressionStandard group cognitive behavioral therapy utilizing the BRIGHT manual for depression |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in CBT group at San Francisco General Hospital
Key exclusion criteria (2 listed)
- Active suicidality
- Active and severe psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CBT for Depression with MoodTextAlso: Group CBT for Depression with HealthySMSMobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis. | Behavioural | Group CBT for Depression with MoodText' |
| Group CBT for DepressionStandard group CBT for depression using BRIGHT manual | Behavioural | Group CBT for Depression |
Primary outcome
PHQ-9 Depression Symptoms
Time frame: 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.
2 secondary outcomes
Attendance
Time frame: 16 weeks
Duration of Therapy Attended
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25373390Aguilera 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.
- Individual participant dataSharing planned: No
Related trials for Depression
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
RecruitingObservational study
Characterization and Treatment of Adolescent Depression
Depression
Active, not recruiting
Preventing Anxiety and Depression in Older Hispanics
Depression, Anxiety
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Aguilera, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group CBT for Depression with MoodText and Group CBT for Depression in people with Depression, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-9 Depression Symptoms (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01083628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.