NCT07107906

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

Recruiting now NA Last updated 19 September 2025

What this trial tests

NA trial testing The CONNECT Program in Loneliness in 128 participants. Currently enrolling.

Timeline

8 September 2025

Primary endpoint
30 September 2026

31 December 2026

Quick facts

Lead sponsor	University of Manitoba
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	128
Start date	8 September 2025
Primary completion	30 September 2026
Estimated completion	31 December 2026
Sites	1 location across Canada

Drugs / interventions tested

• The CONNECT Program
• Community Participation as Usual (Service as Usual)

Conditions studied

• Loneliness — all drugs for Loneliness →
• Social Isolation — all drugs for Social Isolation →
• Depression Disorders — all drugs for Depression Disorders →
• Anxiety — all drugs for Anxiety →

Sponsor

University of Manitoba

Who can join

55 and older, any sex, with Loneliness or Social Isolation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating and implementing The CONNECT Program-A group-based telehealth intervention to reduce social isolation, loneliness, and mental health symptoms in adults 55+ vs routine community programming: Study protocol for a randomized controlled trial.
   Kudar K, Gopinath G, Ross A, Balshaw R, et al · · 2025 · cited 1× · PMID 41218068 · DOI 10.1371/journal.pone.0336031