RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Getting Out of the House: A Behavioral Activation Approach to Support Community Participation With Individuals With Serious Mental Illness

Quick Facts

Study Start:2024-02-15
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06336616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. must respond yes to three questions related to their history with serious mental illness (see below);
  2. 2. a score of 8 or higher on the Center for Epidemiologic Studies Depression Scale - Revised -10 (CES-D-R-10)
  3. 3. have Internet access;
  4. 4. be willing to carry a cell phone with a GPS tracking application;
  5. 5. indicate that they would like to participate more in the community;
  6. 6. be able to communicate in English;
  7. 7. be over the age of 18; and
  8. 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.
  9. 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?",
  10. 2. "Have you ever been hospitalized for this mental health or emotional problem?", and
  11. 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.
  1. 1. those who are unable to give informed consent
  2. 2. those who report having a legal guardian -

Contacts and Locations

Study Contact

Crystal Slanzi, PhD
CONTACT
(215) 204-9664
crystal.slanzi@temple.edu
Mark Salzer, PhD
CONTACT
(215) 204-7879
mark.salzer@temple.edu

Study Locations (Sites)

Temple University
Philadelphia, Pennsylvania, 19120
United States

Collaborators and Investigators

Sponsor: Temple University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-15
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-02-15
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • serious mental illness

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Schizo Affective Disorder
  • Schizophrenia
  • Bipolar Disorder