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
- Conditions
- LonelinessSocial IsolationDepression DisordersAnxiety
- Registration Number
- NCT07107906
- Lead Sponsor
- University of Manitoba
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- 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)
- Cannot communicate in English (verbal or written)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in Psychological Flexibility from Baseline (Acceptance and Action Questionnaire-II) 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). 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.
- Secondary Outcome Measures
Name Time Method 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). Loneliness will be assessed using the De Jong Gierveld Loneliness Scale, a validated 6-item self-report instrument designed to measure emotional and social dimensions of loneliness. Total scores range from 0 to 6, with higher scores indicating greater loneliness and lower scores indicating less loneliness. Loneliness is a key risk factor for late-life depression and anxiety and is associated with negative physical and cognitive health outcomes.
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). Social isolation will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation 8a short form, an 8-item standardized measure of perceived disconnection from others. Scores range from 8 to 40, with higher scores indicating greater social isolation. Social isolation is an objective risk factor for poor mental and physical health and is closely linked to late-life depression, anxiety, and cognitive decline.
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). Emotional support will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support Short Form, a standardized self-report measure evaluating the perceived availability of caring and understanding individuals in one's life. Scores range from 4 to 20, with higher scores indicating greater emotional support. Greater emotional support is associated with reduced risk of depression, better coping with stress, and improved quality of life in older adults.
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). Anxiety symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 4a, a validated 4-item self-report scale capturing core features of anxiety such as fear, worry, and nervousness. Scores range from 4 to 20, with higher scores indicating greater severity of anxiety symptoms. Anxiety is prevalent among older adults and is strongly linked to social isolation and reduced quality of life.
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). Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 4a, a 4-item self-report measure capturing core features such as sadness, hopelessness, and lack of interest in activities. Scores range from 4 to 20, with higher scores indicating greater severity of depressive symptoms. Subsyndromal depressive symptoms are common in late life and are associated with lower quality of life and increased health risk.
Change in Mental Health Literacy from Baseline (Brief Mental Health Literacy 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). Mental health literacy will be assessed using the Brief Mental Health Literacy Scale. This 4-item self-report measure evaluates perceived knowledge about signs and symptoms, possible causes, types of professional help available, and how to seek help for common mental health problems (e.g., anxiety, depression). Respondents rate their knowledge on a 5-point Likert scale (1=not at all, to 5=extremely). Composite scores range from 4 to 20, with higher scores indicating greater perceived mental health literacy. Older adults typically have lower mental health literacy than younger groups, which may hinder service use and self-identification of mental health problems.