NCT06336616 Getting Out of the House: Using Behavioral Activation to Increase Community Participation
| NCT ID | NCT06336616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Temple University |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2024-02-15 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06336616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06336616 currently recruiting?
Yes, NCT06336616 is actively recruiting participants. Contact the research team at crystal.slanzi@temple.edu for enrollment information.
Where is the NCT06336616 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06336616 clinical trial?
NCT06336616 is sponsored by Temple University. The trial plans to enroll 52 participants.