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NCT06336616 · ClinicalTrials.gov registry record · NA
Getting Out of the House: Using Behavioral Activation to Increase Community Participation
A NA study of Schizophrenia and Major Depressive Disorder, sponsored by Temple University.
- Recruiting
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT06336616: Recruiting NA study of Schizophrenia and Major Depressive Disorder, sponsored by Temple University.
NCT06336616 is a NA study of Schizophrenia and Major Depressive Disorder that is actively recruiting participants, run by Temple University. The registered enrollment target is 52 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06336616, a NA study of Schizophrenia and Major Depressive Disorder, is actively recruiting participants, sponsored by Temple University.
- RECRUITING
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The activity logs are open ended forms in which participants are asked to enter in the primary activities they did in a day (e.g., work), the amount of time they did if for (e.g., 2 hours), how effortful it was on a scale of 1-5, and what their mood was before, during, and after the activity on a scale of 1-5. A higher score on effort (5) is indicative of greater effort, and a higher score ono mood indicates a better or more positive mood. Activities type will be analyzed qualitatively.
Conditions Studied
Interventions
- BEHAVIORAL Behavior Activation
Study Locations (1)
Pennsylvania
- Temple University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-02-15 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06336616 shows while recruiting
NCT06336616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (76% lower).
The record links to 4 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Behavior Activation is the first listed.
NCT06336616 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06336616 about?
NCT06336616 is a clinical study titled "Getting Out of the House: Using Behavioral Activation to Increase Community Participation". 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 p...
What is the current status of trial NCT06336616?
This trial is currently recruiting. It is a NA study. The enrollment target is 52 participants. The study started on 2024-02-15. Estimated completion is 2026-12.
What conditions does trial NCT06336616 study?
This clinical trial studies the following conditions: Schizophrenia, Major Depressive Disorder, Bipolar Disorder, Schizoaffective Disorder.
What interventions are being tested in trial NCT06336616?
The interventions under investigation include: Behavior Activation (BEHAVIORAL).
Who is sponsoring clinical trial NCT06336616?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06336616 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06336616's enrollment target sits among peer trials
52 204th of 315 higher than 111 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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