AzTrials
AzTrials

LonelinessNCT07107906

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

A study testing The CONNECT Program and Community Participation as Usual (Service as Usual) in people with Loneliness and Social Isolation, run by University of Manitoba at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Loneliness, Social Isolation, Depression Disorders
What is being tested?
The CONNECT Program and Community Participation as Usual (Service as Usual)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteCanada
Study dates
8 Sep 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Cannot communicate in English (verbal or written)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristin AA Reynolds, PhD contact

204-474-8260

Kristin.Reynolds@umanitoba.ca

Canada1 site, 1 recruiting

  • University of Manitoba

    Winnipeg, Manitoba, R3T 2M8

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

    Recruiting

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
The CONNECT Program, Community Participation as Usual (Service as Usual)
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
Medical subject headings
Social Isolation, Anxiety Disorders, Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The CONNECT ProgramBehavioural

    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)Behavioural

    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.

Study groups in NCT07107906
Study groupRoleWhat they receive
The CONNECT Program firstExperimentalParticipants 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.
Receives: Behavioral: The CONNECT Program; Behavioral: Community Participation as Usual (Service as Usual)
Community-based programming as usual (Service as Usual) firstActive comparatorParticipants 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.
Receives: Behavioral: The CONNECT Program; Behavioral: Community Participation as Usual (Service as Usual)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Change in Loneliness from Baseline (DeJong Gierveld Loneliness Scale)

    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.

    Measured: 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).

  2. Change in Social Isolation from Baseline (PROMIS Social Isolation 8a)

    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.

    Measured: 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).

  3. Change in Emotional Support from Baseline (PROMIS Emotional Support)

    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.

    Measured: 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).

  4. Change in Anxiety Symptoms from Baseline (PROMIS Anxiety Short Form 4a)

    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.

    Measured: 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).

  5. Change in Depressive Symptoms from Baseline (PROMIS Depression Short Form 4a)

    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.

    Measured: 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).

  6. Change in Mental Health Literacy from Baseline (Brief Mental Health Literacy Scale)

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start8 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07107906
Sponsor's protocol ID
HE2024-0150
Other IDs
58465
Status last verified
Sep 2025
First submitted
24 Jul 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 19444706

  • Harasemiw O, Newall N, Shooshtari S, Mackenzie C, Menec V. From Social Integration to Social Isolation: The Relationship Between Social Network Types and Perceived Availability of Social Support in a National Sample of Older Canadians. Res Aging. 2018 Sep;40(8):715-739. doi: 10.1177/0164027517734587. Epub 2017 Oct 5.

    PubMed 28982271

  • Hahn EA, DeWalt DA, Bode RK, Garcia SF, DeVellis RF, Correia H, Cella D; PROMIS Cooperative Group. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychol. 2014 May;33(5):490-9. doi: 10.1037/hea0000055. Epub 2014 Jan 20.

    PubMed 24447188

  • Hayes SC, Ciarrochi J, Hofmann SG, Chin F, Sahdra B. Evolving an idionomic approach to processes of change: Towards a unified personalized science of human improvement. Behav Res Ther. 2022 Sep;156:104155. doi: 10.1016/j.brat.2022.104155. Epub 2022 Jul 3.

    PubMed 35863243

  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PubMed 22035996

  • Sibbald B, Roberts C. Understanding controlled trials. Crossover trials. BMJ. 1998 Jun 6;316(7146):1719. doi: 10.1136/bmj.316.7146.1719. No abstract available.

    PubMed 9614025

  • Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019 Oct;280:112513. doi: 10.1016/j.psychres.2019.112513. Epub 2019 Aug 9.

    PubMed 31434011

  • Reynolds KA, Sommer J, Mackenzie CS, Koven L. A Profile of Social Participation in a Nationally Representative Sample of Canadian Older Adults: Findings from the Canadian Longitudinal Study on Aging. Can J Aging. 2022 Dec;41(4):505-513. doi: 10.1017/S0714980822000150. Epub 2022 Jul 28.

    PubMed 35899988

Questions about this trial

What is this clinical trial studying?

A study testing The CONNECT Program and Community Participation as Usual (Service as Usual) in people with Loneliness and Social Isolation, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristin AA Reynolds, PhD (204-474-8260, Kristin.Reynolds@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07107906, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in