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Psychotherapeutic Text Messaging for Depression Pilot Study (TEXT4U)

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depression focused on measuring Major Depression, Text Messaging, Guided Self-Help

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Inpatient Psychiatry Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Text Messaging

Arm Description

Outcomes

Primary Outcome Measures

Intervention Feasibility
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

Perceived Helpfulness of Messages
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.
Change in Depression Symptoms
Patient's current level of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9).

Full Information

First Posted
September 1, 2015
Last Updated
August 16, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02872454
Brief Title
Psychotherapeutic Text Messaging for Depression Pilot Study
Acronym
TEXT4U
Official Title
Psychotherapeutic Text Messaging for Depression Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major Depression, Text Messaging, Guided Self-Help

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Messaging
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging
Intervention Description
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 Measure Information:
Title
Intervention Feasibility
Description
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.
Time Frame
6 and 12 weeks post-baseline
Secondary Outcome Measure Information:
Title
Perceived Helpfulness of Messages
Description
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.
Time Frame
baseline and12 weeks post-baseline
Title
Change in Depression Symptoms
Description
Patient's current level of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9).
Time Frame
6 and 12 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Michigan Inpatient Psychiatry Unit
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Psychotherapeutic Text Messaging for Depression Pilot Study

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