Clinical trial NCT06336616: Getting Out of the House: Using Behavioral Activation to Increase Community Participation
Official title: Getting Out of the House: A Behavioral Activation Approach to Support Community Participation With Individuals With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Schizo Affective Disorder
Schizophrenia
Bipolar Disorder
Keywords: serious mental illness
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-03-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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 -

Primary outcomes:
measure: Activity Logs
timeFrame: administered 26 times: 1 time per week for 26 weeks.
measure: Participation Checklist
timeFrame: administered 26 times: 1 time per week for 26 weeks
measure: Behavior Activation for Depression Scale
timeFrame: administered 26 times: 1 time per week for 26 weeks
measure: Temple University Community Participation Measure
timeFrame: administered 3 times: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the intervention
measure: Community Mobility (Global Positioning System; GPS)
timeFrame: administered 3 times for 2 weeks: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the end of the intervention
measure: Community Mobility (Global Positioning System; GPS)
timeFrame: administered 3 times for 2 weeks: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the end of the intervention
Secondary outcomes:
measure: Lerman Quality of Life Interview
timeFrame: administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: New General Self-Efficacy Scale (adapted to participation)
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Recovery Assessment Scale (RAS)
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Activity Assessment Scale
timeFrame: administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Capabilities and Opportunities for Participation Questionnaire
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Self-Control and Self-Management Scale
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Habit Strength Scale
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: University of California Los Angeles Loneliness Scale
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Lehman Quality of LIfe (QOL) Interview Social Relations sub scale
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Hopkins Symptoms Checklist
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: The Life Engagement Test
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: The University of Rhode Island Change Assessment Measure (URICA)
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
measure: Reward Probability Index
timeFrame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References: