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NCT Number: NCT02872454

Psychotherapeutic Text Messaging for Depression Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Inpatient Psychiatry Unit

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: TEXT4U

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2016
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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