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Clinical Trials/NCT02872454
NCT02872454CompletedNot Applicable

Psychotherapeutic Text Messaging for Depression Pilot Study

University of Michigan1 site in 1 country190 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
190
Locations
1
Primary Endpoint
Intervention Feasibility

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Text Messaging

Experimental

Intervention: Text Messaging (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Perceived Helpfulness of Messages(baseline and12 weeks post-baseline)
  • Change in Depression Symptoms(6 and 12 weeks post-baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paul Pfeiffer

Principal Investigator

University of Michigan

Study Sites (1)

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