Psychotherapeutic Text Messaging for Depression Pilot Study

Major Depression Clinical Trial

— TEXT4U  

Official title:

Psychotherapeutic Text Messaging for Depression Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872454
• Other study ID #: HUM00090058
• Status: Completed
• Phase: N/A
• First received: September 1, 2015
• Last updated: August 16, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Inpatient Psychiatry Unit	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	baseline and12 weeks post-baseline	No
Secondary	Change in Depression Symptoms	Patient's current level of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9).	6 and 12 weeks post-baseline	No