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

NCT07107906 | Recruiting

• 2 other identifiers: HE2024-015058465
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Psychological Flexibility from Baseline (Acceptance and Action Questionnaire-II)

  Psychological flexibility will be measured using the Acceptance and Action Questionnaire-II, a 7-item self-report scale. Scores range from 7 to 49, with higher scores indicating greater psychological inflexibility, and lower scores indicating greater psychological flexibility. Psychological flexibility is a core target of Acceptance and Commitment Therapy and has been shown to be a transdiagnostic mechanism of change in psychotherapy outcomes.

  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 Outcomes (6)

• Change in Loneliness from Baseline (DeJong Gierveld Loneliness Scale)

  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)

  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)

  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)

  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)

  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).

Other Outcomes (22)

• Acceptability of the CONNECT Program: Post-Program Survey

  Once post-program (at Week 6 or Week 12, depending on intervention sequence).

• Acceptability of the CONNECT Program: Intervention Content Evaluation

  Once post-program (Week 6 or Week 12).

• Acceptability of the CONNECT Program: Exit Interview

  Once post-program (at Week 6 or Week 12).

Study Arms (2)

The CONNECT Program first

EXPERIMENTAL

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.

Behavioral: The CONNECT Program; Behavioral: Community Participation as Usual (Service as Usual)

Community-based programming as usual (Service as Usual) first

ACTIVE COMPARATOR

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.

Behavioral: The CONNECT Program; Behavioral: Community Participation as Usual (Service as Usual)

Interventions

The CONNECT Program BEHAVIORAL

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-based programming as usual (Service as Usual) first; The CONNECT Program first

Community Participation as Usual (Service as Usual) BEHAVIORAL

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.

Community-based programming as usual (Service as Usual) first; The CONNECT Program first

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Cannot communicate in English (verbal or written)

Sponsors & Collaborators

• University of Manitoba: lead
• A & O: Support Services for Older Adults: collaborator
• Brella Community Services Society: collaborator
• Senior Citizens Assistance Program: collaborator
• CHI - Centre for Healthcare Innovation: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2M8, Canada

RECRUITING

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MeSH Terms

Conditions

Social Isolation; Anxiety Disorders; Depression; Psychological Well-Being

Interventions

Community Participation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Mental Disorders; Behavioral Symptoms; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Community Health Services; Health Services; Health Care Facilities Workforce and Services; Consumer Organizations; Organizations; Health Care Economics and Organizations

Central Study Contacts

Kristin AA Reynolds, PhD

CONTACT

204-474-8260; Kristin.Reynolds@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A non-affiliated researcher will generate the randomization sequence and assign participant IDs to one of two intervention sequences (the CONNECT program - Community programming as usual or Community programming as usual - the CONNECT program) prior to recruitment. Each participant will be assigned a unique ID, and outcome data will be collected and analyzed using only these IDs. The study coordinator will be unblinded to group assignment for the purpose of managing recruitment, scheduling, and follow-up assessments. However, outcome investigator responsible for analyzing primary, secondary and other pre-specified outcomes will remain blinded to group allocation and will use de-identified datasets for analysis. The outcome assessors responsible for collecting baseline, post-intervention, and follow-up data are blinded in this study. Participants, facilitators, and the study coordinator will not be blinded due to the nature of behavioral interventions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants within each community site will be randomized to one of two sequences: (1) The CONNECT Program followed by community programming as usual, or (2) community programming as usual followed by The CONNECT Program. Each phase consists of a 6-week intervention. After the first phase, participants will cross over to receive the alternative condition. All participants will receive both interventions during the study period.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 6, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)