- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06424483
Love Group for Geriatric Psychiatry Outpatients
January 26, 2026 updated by: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Awareness, Courage, and Love Group Psychotherapy for Geriatric Psychiatry Outpatients
Loneliness is a key predictor of mortality in older adults, and is a prominent risk factor for mental and physical illness in older adulthood.
The goal of this study is to determine the feasibility and acceptability of a group loneliness intervention in geriatric psychiatry outpatients.
This type of group loneliness intervention is based on functional analytic psychotherapy (FAP), called Awareness, Courage, and Love (ACL) Groups.
The objective of this clinical trial is to adapt, implement, and evaluate the ACL group for outpatients.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of this clinical trial is to adapt, implement, and evaluate a type of loneliness group intervention called Awareness, Courage, and Love Groups for older adult outpatients diagnosed with a psychiatric disorder.
The following research questions will be answered: (a) Are ACL groups with geriatric psychiatry outpatients feasible and acceptable?
(b) Do such ACL groups demonstrate preliminary efficacy?
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6C0A7
- St. Joseph's Health Care London
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Older adults with psychiatric disorder(s)
Exclusion Criteria:
- Individuals who are disoriented to person, delirious, unable to tolerate or participate meaningfully in the group, or otherwise unable to provide consent to research and psychotherapy
- Unable to speak English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist
Waitlist control
|
|
|
Experimental: Treatment: Group psychotherapy
Treatment group receiving psychotherapy
|
Awareness, Courage, and Love (ACL) groups are an outgrowth of functional analytic psychotherapy, which is an empirically-based behavioural therapy that emphasizes the principle of positive reinforcement within relationships (Holman et al., 2017; Kanter et al., 2010; Kohlenberg & Tsai, 1991; Tsai et al., 2009a).
Awareness involves the practice of mindfulness, and in particular, the noticing of emotions within oneself and in others (Tsai et al., 2009b).
Courage refers to engaging in vulnerable self-disclosures and practicing boundaried support.
Love encompasses healthy caring for oneself and others, and in particular, responding affirmingly to another person's self-disclosures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative Program Satisfaction
Time Frame: Up to 2 months
|
Brief measure of program satisfaction.
The minimum value is 0, the maximum value is 16, and higher scores indicate a better outcome.
|
Up to 2 months
|
|
De Jong Gierveld Loneliness Scale
Time Frame: Up to 2 months
|
Brief measure of loneliness.
The minimum value is 0, the maximum value is 11, and higher scores indicate a worse outcome.
|
Up to 2 months
|
|
Attendance and attrition (defined as the number of participants that withdraw (numerator)/number of participants randomised (denominator))
Time Frame: Up to 2 months
|
Measure of feasibility.
Captured across 8 sessions, comparing pre to post.
|
Up to 2 months
|
|
UCLA Loneliness Scale (Neto)
Time Frame: Up to 2 months
|
Brief measure of loneliness.
The minimum value is 6, the maximum value is 24, and higher scores indicate a worse outcome.
|
Up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cantril Self-Anchoring Striving Scale
Time Frame: Up to 2 months
|
1 item pictorial scale of subjective wellbeing from 0 (minimum) to 10 (maximum).
A higher score indicates a better outcome.
|
Up to 2 months
|
|
Adaptation of Inclusion of Other in Self Scale
Time Frame: Up to 2 months
|
Brief single-item pictorial measure of social closeness.
The minimum value is 1, the maximum value is 7, and higher scores indicate a better outcome.
|
Up to 2 months
|
|
Relational Health Indices
Time Frame: Up to 2 months
|
Brief measure of group relational health.
The minimum value is 8, the maximum value is 40, and higher scores indicate a better outcome.
|
Up to 2 months
|
|
Sacred Moment Qualities
Time Frame: Up to 2 months
|
Brief measure of perceived sacred qualities, adapted from Pargament et al. (2014).
The minimum value is 11, the maximum value is 55, and higher scores indicate a better outcome.
|
Up to 2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Questionnaire
Time Frame: Up to 2 months
|
Brief open-ended questions about program satisfaction.
Responses are qualitative.
|
Up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Serena Wong, Ph.D., St. Joseph's Health Care London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 30, 2028
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
May 16, 2024
First Posted (Actual)
May 22, 2024
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.