Evaluating and Implementing The CONNECT Program - a Group-Based Telehealth Intervention to Reduce Social Isolation, Loneliness, and Mental Health Symptoms in Adults Ages 55+, Compared to Routine Community-Based Programming

Official title

The CONNECT Program: Engaging Community Organizations in the Implementation and Evaluation of a Group Telehealth Mental Health Program for Older Canadians

Overview

Older adults in Canada are experiencing increasing levels of social isolation, loneliness, and mental health challenges, including anxiety and depression - trends that have worsened during and following the COVID-19 pandemic. Research consistently shows that loneliness and social isolation are associated with poorer mental and physical health outcomes, increased risk of dementia, and increased mortality. At the same time, social connection has a strong protective impact on health and well-being. Community-based programs that promote both social engagement and psychological support are urgently needed, particularly since older adults are less likely to access formal mental health services. Approximately 3-11% of older adults meet diagnostic criteria for mood or anxiety disorders each year, with even more experiencing elevated symptoms that greatly influence quality of life. Subsyndromal depression in late life is estimated to occur two to three times more often than major depressive disorder. Despite these needs, up to 70% of older adults with anxiety or mood disorders do not access psychological services, often due to low mental health literacy or practical barriers to care. At the same time, participation in community activities is associated with improved emotional well-being, greater social support, and lower rates of depression and anxiety. To bridge this need for support, our team developed and pilot-tested The CONNECT Program - a group-based mental health intervention for adults 55 years and older, delivered via telephone or virtually. The CONNECT Program is grounded in Acceptance and Commitment Therapy (ACT), self-compassion, and theories of successful aging, and aims to improve psychological flexibility; reduce loneliness, social isolation, and co-occurring symptoms of depression and anxiety. A Manitoba pilot study (N = 34) demonstrated promising outcomes in terms of feasibility, acceptability, and preliminary effectiveness with the telephone-based group intervention. The current trial will evaluate the implementation and effectiveness of The CONNECT Program in four Canadian provinces (British Columbia, Manitoba, New Brunswick, Saskatchewan), using an implementation-effectiveness hybrid design and a crossover randomized controlled trial. This study compares The CONNECT Program, delivered via telephone or virtually, to routine community programming (i.e., community participation as usual), which may occur in telephone, virtual, or in-person formats. The primary outcome is psychological flexibility; secondary outcomes include loneliness, social isolation, anxiety, depression, emotional support, mental health literacy. Implementation outcomes will be evaluated following the Proctor et al. framework. This trial will contribute evidence on the mental health needs of adults 55+ and the value of low-barrier, community-based programs delivered remotely. Findings will guide further national and international implementation of The CONNECT Program and similar initiatives aimed at addressing the challenges of loneliness, social isolation, and mental health problems in late life.

Interventions

• Behavioral The CONNECT Program
  A group-based telehealth intervention grounded in Acceptance and Commitment Therapy (ACT), self-compassion, and successful aging theories, aimed at reducing social isolation, loneliness, and mental health symptoms among adults 55+. Delivered over six weeks via group phone or Zoom sessions. The CONNECT Program includes 6 weekly 90-minute group sessions, with structured workbooks and homework. The CONNECT Program is delivered in two modalities (group telephone or Zoom videoconferencing).
• Behavioral Community Participation as Usual (Service as Usual)
  These community-based programs may include social, educational, or recreational group sessions that are already offered by local organizations - either in person, by phone, or virtually.

Primary outcome measures

• Change in Psychological Flexibility from Baseline (Acceptance and Action Questionnaire-II) [Time frame: At baseline (Week 0), after community-based programming as usual if delivered first (Week 6), after the CONNECT program (Week 6 or 12 depending on sequence), and at 6-month follow-up (Week 30-36).]

Secondary outcome measures (6)

• Change in Loneliness from Baseline (DeJong Gierveld Loneliness Scale) [Time frame: At baseline (Week 0), after community-based programming as usual if delivered first (Week 6), after the CONNECT program (Week 6 or 12 depending on sequence), and at 6-month follow-up (Week 30-36).]
• Change in Social Isolation from Baseline (PROMIS Social Isolation 8a) [Time frame: At baseline (Week 0), after community-based programming as usual if delivered first (Week 6), after the CONNECT program (Week 6 or 12 depending on sequence), and at 6-month follow-up (Week 30-36).]
• Change in Emotional Support from Baseline (PROMIS Emotional Support) [Time frame: At baseline (Week 0), after community-based programming as usual if delivered first (Week 6), after the CONNECT program (Week 6 or 12 depending on sequence), and at 6-month follow-up (Week 30-36).]
• Change in Anxiety Symptoms from Baseline (PROMIS Anxiety Short Form 4a) [Time frame: At baseline (Week 0), after community-based programming as usual if delivered first (Week 6), after the CONNECT program (Week 6 or 12 depending on sequence), and at 6-month follow-up (Week 30-36).]
• Change in Depressive Symptoms from Baseline (PROMIS Depression Short Form 4a) [Time frame: At baseline (Week 0), after community-based programming as usual if delivered first (Week 6), after the CONNECT program (Week 6 or 12 depending on sequence), and at 6-month follow-up (Week 30-36).]
• Change in Mental Health Literacy from Baseline (Brief Mental Health Literacy Scale) [Time frame: At baseline (Week 0), after community-based programming as usual if delivered first (Week 6), after the CONNECT program (Week 6 or 12 depending on sequence), and at 6-month follow-up (Week 30-36).]

Eligibility criteria

Inclusion criteria

• Adults aged 55 years or older
• Able to speak, read, and understand English
• Can manage hearing or vision changes well enough to participate in group conversations
• Self-reported experiences of loneliness, social isolation, and/or mental health challenges (e.g., anxiety or depressive symptoms)

Exclusion criteria

• Cannot communicate in English (verbal or written)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• University of Manitoba — Winnipeg

Publications

• Reynolds K, Ceccarelli L, Mackenzie CS. Reliability and validity of a new brief measure of mental health literacy. Presented at: CPA 2020 Virtual Series; 2020.
• Duncan BL, Miller SD. Group Session Rating Scale. Chicago, IL: International Center for Clinical Excellence; 2007.
• De Jong Gierveld J, Van Tilburg T. A 6-item scale for overall, emotional, and social loneliness: confirmatory tests on survey data. Res Aging. 2006 Sep;28(5):582-598. doi: 10.1177/0164027506289723.
• Salinas J, Beiser AS, Samra JK, O'Donnell A, DeCarli CS, Gonzales MM, Aparicio HJ, Seshadri S. Association of Loneliness With 10-Year Dementia Risk and Early Markers of Vulnerability for Neurocognitive Decline. Neurology. 2022 Mar 29;98(13):e1337-e1348. doi: 10.1212/WNL.0000000000200039. Epub 2022 Feb 7. PMID 35131906
• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426
• McCracken LM, Vowles KE, Zhao-O'Brien J. Further development of an instrument to assess psychological flexibility in people with chronic pain. J Behav Med. 2010 Oct;33(5):346-54. doi: 10.1007/s10865-010-9264-x. Epub 2010 May 26. PMID 20502955
• Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21. PMID 21697139
• Golden J, Conroy RM, Lawlor BA. Social support network structure in older people: underlying dimensions and association with psychological and physical health. Psychol Health Med. 2009 May;14(3):280-90. doi: 10.1080/13548500902730135. PMID 19444706

Identifiers

NCT: NCT07107906 · HE2024-0150 · 58465

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗