Getting Out of the House: Using Behavioral Activation to Increase Community Participation

Temple University

Status: Enrolling

Conditions: Major Depressive Disorder; Schizophrenia; Bipolar Disorder; Schizo Affective Disorder

Treatments: Behavioral: Behavior Activation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06336616

31164

Details and patient eligibility

About

The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.

The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:

1. To determine if the intervention leads to increases the frequency and variety of activities.
2. To determine if the intervention leads to increases in community mobility.
3. To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.
4. To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).

Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.

For data collection, participants will also be asked to:

1. Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;
2. Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and
3. Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.

The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. must respond yes to three questions related to their history with serious mental illness (see below);
2. a score of 8 or higher on the Center for Epidemiologic Studies Depression Scale - Revised -10 (CES-D-R-10)
3. have Internet access;
4. be willing to carry a cell phone with a GPS tracking application;
5. indicate that they would like to participate more in the community;
6. be able to communicate in English;
7. be over the age of 18; and
8. and be available on for the day and time (i.e., Monday, Tuesday, Wednesday, Thursday, or Friday) the intervention is scheduled for each cohort.

Questions related to history with serious mental illness:

1. "Have you ever been told by a psychiatrist or other mental health professional that you have major depression, bipolar disorder, manic depression, schizophrenia or schizoaffective disorder?",
2. "Have you ever been hospitalized for this mental health or emotional problem?", and
3. "Has this mental health or emotional problem substantially interfered with or limited your ability to participate in any major life activities such as work, school, recreation, social activities, religious activities, family relationships, or caring for yourself?" Answering yes to these 3 questions would be indicative of a lifetime serious mental illness.

Exclusion criteria

1. those who are unable to give informed consent
2. those who report having a legal guardian -

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Intervention group

Experimental group

Description:

All participants will receive an online behavioral intervention for 10 weeks, followed by monthly maintenance sessions for 3 months.

Treatment:

Behavioral: Behavior Activation