Psychotherapeutic Text Messaging for Depression Pilot Study

NCT02872454 | Completed

• 1 other identifier: HUM00090058
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

Major Depression; Text Messaging; Guided Self-Help

Outcome Measures

Primary Outcomes (1)

• 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.

  6 and 12 weeks post-baseline

Secondary Outcomes (2)

• Perceived Helpfulness of Messages

  baseline and12 weeks post-baseline

• Change in Depression Symptoms

  6 and 12 weeks post-baseline

Study Arms (1)

Text Messaging

EXPERIMENTAL

Behavioral: Text Messaging

Interventions

Text Messaging BEHAVIORAL

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.

Text Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide voluntary informed consent for any reason

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Inpatient Psychiatry Unit

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: August 19, 2016
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

US (1)