Psychotherapeutic Text Messaging for Depression Pilot Study (TEXT4U)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02872454
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Information provided by (Responsible Party):
Paul Pfeiffer, University of Michigan

Brief Summary:

Major depression is the leading cause of disability in the United States and is a major contributor to suicide, a leading cause of premature death. The majority of individuals with depression do not receive adequate pharmacologic or psychotherapeutic treatment due to difficulty accessing services or stopping treatment due to side effects, non-response, or the stigma associated with attending mental health clinic visits. Mobile health information technology services, such as text messaging, have the potential to provide effective self-management support for depression to nearly every adult in the US with depression. Guided self-help via text messaging has been shown to be effective for improving a range of health behaviors as well as symptoms of depression. However, previously studied depression text messaging services have not utilized the breadth of psychotherapeutic techniques shown to be effective for depression nor have they attempted to tailor the psychotherapeutic content to the individual in order to improve acceptability and outcomes. Advanced artificial intelligence methods (e.g., reinforcement learning) offers the capability to weed out ineffective messages and to target messages to individuals in order to substantially improve program effectiveness. This pilot study is the first step in towards developing an artificially intelligent text message service for depression.

The specific aims of the study are to: 1) demonstrate the feasibility of recruiting and enrolling participants from the general population of US adults and delivering a text-messaging intervention for depression, 2) determine whether there are differences in the perceived helpfulness of messages derived from different psychotherapeutic treatment modalities, and whether these differences are moderated by participant characteristics (e.g., age, gender, depression symptom severity), 3) determine whether messages derived from different psychotherapeutic treatment modalities or their perceived helpfulness are associated with changes in depression symptoms, and whether these relationships are moderated by participant characteristics.

Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Text Messaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychotherapeutic Text Messaging for Depression Pilot Study
Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Text Messaging Behavioral: Text Messaging
Each week, enrolled participants will receive daily text messages from one of three randomly assigned psychotherapeutic modalities—cognitive restructuring, behavioral activation, and techniques based on Acceptance and Commitment Therapy (ACT)—for a total of 12 weeks. The messages were developed, reviewed, and refined by a multidisciplinary team of experienced therapists, including social workers, psychologists, and psychiatrists.

Primary Outcome Measures :
  1. Intervention Feasibility [ Time Frame: 6 and 12 weeks post-baseline ]
    Study team's ability to deliver the intervention as a measure of feasibility. Measured by at least 50% of patients who complete the screening questionnaire choosing to enroll in the study, at least 70% of participants completing follow-up measures at 12 weeks, and the study meeting its enrollment goal of 250 patients in 12 months.

Secondary Outcome Measures :
  1. Perceived Helpfulness of Messages [ Time Frame: baseline and12 weeks post-baseline ]
    Patient's belief that the program will be helpful as measured by the Credibility/Expectancy Questionnaire and patient's rating of the program at 12 weeks post-baseline as measured by the Study Experience Questionnaire.

  2. Change in Depression Symptoms [ Time Frame: 6 and 12 weeks post-baseline ]
    Patient's current level of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • US resident
  • Age 18 or older
  • PHQ-9 screening score of 10 or more
  • Has a personal cellular phone with a text messaging plan that would allow for as many as 200 additional text messages per month, and agreement that the participant would be responsible for any related charges
  • Has a valid e-mail address
  • Fluent in English

Exclusion Criteria:

  • Unable to provide voluntary informed consent for any reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02872454

United States, Michigan
University of Michigan Inpatient Psychiatry Unit
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan

Responsible Party: Paul Pfeiffer, Principal Investigator, University of Michigan Identifier: NCT02872454     History of Changes
Other Study ID Numbers: HUM00090058
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Paul Pfeiffer, University of Michigan:
Major Depression
Text Messaging
Guided Self-Help

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Psychotropic Drugs