Text Messaging and Cognitive Behavioral Therapy for Depression (Txt4CBT)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01083628
First received: February 19, 2010
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

This study will assess the feasibility and acceptability of using mobile phone text messages (SMS) as adjuncts to existing group cognitive-behavioral treatment (CBT) for depression at San Francisco General Hospital. Patients in current groups will be given the option to participate in a text-messaging adjunct in lieu of the usual paper and pencil "homework" that is typically assigned during group sessions. They will also be provided with CBT relevant "tips and skills" to employ during particularly stressful times. Participants will receive daily text messages asking them what their mood is, this will help them become aware of their mood state and provide feedback to the group leaders as to the progress of the patient. Patients will also receive 1-2 additional messages a day depending on the module of focus for that month (i.e. thoughts, activities, people, and health). These additional messages include 1) thought tracking (both positive and negative), 2) tracking of pleasant activities, 3) tracking of positive and negative contacts, 4) tracking of physical wellbeing. Additionally, participants will receive reminders of weekly group meetings in an attempt to improve adherence. Patients that are taking medication will be offered to receive reminders to take medication according to their prescribed regimen. Another component of the SMS messages will allow patients to text the keyword STRESSED and receive a randomly generated message that will suggest cognitive and behavioral tips to counteract the stress or sad mood. They will also be able to text the word HELP and receive the number for a suicide hotline or be prompted to contact 911 for an emergency. Lastly, participants will be given feedback on their mood, behaviors and cognitions through visual graphs that display their status over time. This will allow patients to see the connection between mood behavior and cognition. This study is not intended to test hypotheses.


Condition Intervention Phase
Depression
Behavioral: Txt4Mood
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using Text Messaging to Enhance Cognitive Behavioral Therapy (CBT) for Depression

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Depression Symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Depression symptoms according to 20 item CES-D measure.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Qualitative reports of satisfaction with text messaging as an adjunct to psychosocial treatment.


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Text Messaging Adjunct Behavioral: Txt4Mood
Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in CBT group at San Francisco General Hospital

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083628

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Adrian Aguilera, Ph.D. University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01083628     History of Changes
Other Study ID Numbers: 68556-35551-01
Study First Received: February 19, 2010
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014