RECRUITING

A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program

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 clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. The Hopeful and Healthy Living (HHL) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. We predict that: * Individuals who participate in the HHL intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (TAU). * Individuals who participate in the HHL intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. * Individuals who participate in the HHL intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU. In this trial, participants will be either receive the HHL intervention or participate in their regular treatment activities (treatment as usual). HHL vs. TAU will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet. Participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. After completing the baseline assessment, those who are in the experimental group will participate in the 16-week long HHL group intervention.

Official Title

Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program

Quick Facts

Study Start:2025-03-12
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06940843

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:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Alexa R Trolley-Hanson, MS OTR/L
CONTACT
16037480379
athanson@bu.edu
Susan McGurk, PhD
CONTACT
617-353-3549
mcgurk@bu.edu

Principal Investigator

Susan McGurk, PhD
PRINCIPAL_INVESTIGATOR
Boston University
Kim Mueser, PhD
PRINCIPAL_INVESTIGATOR
Boston University

Study Locations (Sites)

Bay Cove Center Club
Boston, Massachusetts, 02114
United States
Bay Cove Transitions of Boston
Boston, Massachusetts, 02122
United States

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

  • Susan McGurk, PhD, PRINCIPAL_INVESTIGATOR, Boston University
  • Kim Mueser, PhD, PRINCIPAL_INVESTIGATOR, Boston 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 Date2025-03-12
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2025-03-12
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • psychosocial interventions
  • cognitive interventions
  • social skills interventions
  • healthy lifestyle interventions
  • older adults with SMI

Additional Relevant MeSH Terms

  • Serious Mental Illness
  • Older Adults