跳至主要内容
临床试验/NCT07107906
NCT07107906招募中不适用

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

University of Manitoba1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
1
主要终点
Change in Psychological Flexibility from Baseline (Acceptance and Action Questionnaire-II)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •Cannot communicate in English (verbal or written)

研究组 & 干预措施

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.

干预措施: The CONNECT Program (Behavioral)

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.

干预措施: Community Participation as Usual (Service as Usual) (Behavioral)

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.

干预措施: The CONNECT Program (Behavioral)

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.

干预措施: Community Participation as Usual (Service as Usual) (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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).)
  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Reynolds

Associate Professor

University of Manitoba

研究点 (1)

Loading locations...

相似试验