Recruiting

CONNECT Program

Sponsor:

University of Manitoba

Code:

NCT07107906

Conditions

Loneliness

Social Isolation

Depression Disorders

Anxiety

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

The CONNECT Program

Community Participation as Usual (Service as Usual)

Study Details

Brief summary:

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.

Conditions

Loneliness

Social Isolation

Depression Disorders

Anxiety

Study ID

NCT07107906

Start date

Sep 8, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: The CONNECT Program first

Participants in this arm will receive The CONNECT Program during the first 6-week phase, followed by community participation as usual during the second 6-week phase.

active comparator: Community-based programming as usual (Service as Usual) first

Participants in this arm will receive community participation as usual during the first 6-week phase, followed by The CONNECT Program during the second 6-week phase. Community participation as usual refers to the regular group programs already offered by community organizations in-person, over the phone or virtually.

Interventions

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).

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 measure

  • 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). ]

Central Contacts and Locations

Central contacts

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3T 2M8

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • Psychological Flexibility
  • Loneliness
  • Social Isolation
  • Anxiety
  • Depression
  • Older adult
  • Aged
  • Psychotherapy, Group
  • Acceptance and Commitment Therapy
  • Mental Health
  • Telemedicine
  • Mental Health Teletherapy
  • Community Mental Health Services
  • Community-Based Participatory Research
  • Program Evaluation
  • Randomized Controlled Trial
  • Implementation Effectiveness Hybrid Design
  • Cross-Over Studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-09-19.