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

NCT06336616 | Recruiting

• 1 other identifier: 31164
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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. 1.To determine if the intervention leads to increases the frequency and variety of activities.
2. 2.To determine if the intervention leads to increases in community mobility.
3. 3.To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.
4. 4.To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).
5. 5.Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;
6. 6.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
7. 7.Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.

Conditions

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

Keywords

serious mental illness

Outcome Measures

Primary Outcomes (6)

• Activity Logs

  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.

  administered 26 times: 1 time per week for 26 weeks.

• Participation Checklist

  Participants will be asked to state whether they did an activity from a list of 20 items. Response options include yes or no. A greater number of "yes" responses will indicate a greater level of participation that week.

  administered 26 times: 1 time per week for 26 weeks

• Behavior Activation for Depression Scale

  The behavior activation depression scale measures related to activity, social interaction, and negative thinking or feelings There are 25 statements measured on a 6-point Likert scale varying from not at all to completely. The range of scores is 0 to 54, with high scores representing higher behavioral activation.activities

  administered 26 times: 1 time per week for 26 weeks

• Temple University Community Participation Measure

  Measures engagement in 29 participation areas, if those areas are important to them, how often they did them and if it was enough, not enough, or too much. Higher reported frequency across a greater number of areas indicates higher rates of participation. Higher number of activities reported as being important and done enough indicate greater sufficiency of participation.

  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

• Community Mobility (Global Positioning System; GPS)

  Participants will carry a cellphone that will track their movements in the community using a GPS app. GPS data shows movements in the community in distance traveled in kilometers. This will be analyzed as total distance traveled.

  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

• Community Mobility (Global Positioning System; GPS)

  Participants will carry a cellphone that will track their movements in the community using a GPS app. GPS data shows locations participants go to in the community with GPS coordinates. This will be analyzed as the number of locations visited.

  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 (13)

• Lerman Quality of Life Interview

  administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later

• New General Self-Efficacy Scale (adapted to participation)

  administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later

• Recovery Assessment Scale (RAS)

  administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later

• Activity Assessment Scale

  administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later

• Capabilities and Opportunities for Participation Questionnaire

  administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Behavioral: Behavior Activation

Interventions

Behavior Activation BEHAVIORAL

Participants will be taught to identify meaningful activities, set goals, use environmental cues, self-reward, to identify barriers and facilitators, and learn new skills to support them to develop self-management skills and new habits.

Also known as: SWITCH

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must respond yes to three questions related to their history with serious mental illness (see below);
• a score of 8 or higher on the Center for Epidemiologic Studies Depression Scale - Revised -10 (CES-D-R-10)
• have Internet access;
• be willing to carry a cell phone with a GPS tracking application;
• indicate that they would like to participate more in the community;
• be able to communicate in English;
• be over the age of 18; and
• 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:
• "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?",
• "Have you ever been hospitalized for this mental health or emotional problem?", and
• "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.

You may not qualify if:

• those who are unable to give informed consent
• those who report having a legal guardian -

Sponsors & Collaborators

• Temple University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19120, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Psychotic Disorders; Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders

Central Study Contacts

Crystal Slanzi, PhD

CONTACT

(215) 204-9664; crystal.slanzi@temple.edu

Mark Salzer, PhD

CONTACT

(215) 204-7879; mark.salzer@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 29, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

US (1)