- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05619718
Loneliness Group Intervention
September 22, 2025 updated by: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Loneliness Group Intervention for Geriatric Psychiatry Inpatients
The goal of this pilot study is to determine the feasibility and acceptability of a group loneliness intervention in geriatric psychiatry inpatients.
This type of group loneliness intervention is based on functional analytic psychotherapy and is called Awareness, Courage, and Love Groups.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of our clinical trial is to adapt, implement, and evaluate a type of loneliness group intervention called Awareness, Courage, and Love Groups for older adults in a psychiatric unit.
The following research questions will be answered: (a) Are ACL groups with geriatric psychiatry inpatients 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, N6C 0A7
- Parkwood Institute Mental Health
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Admission to geriatric psychiatry inpatient unit
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
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 |
|---|---|
|
Experimental: Treatment
Treatment group will receive Awareness, Courage, and Love Groups for loneliness.
|
Groups based on the Awareness, Courage, and Love framework from functional analytic psychotherapy
|
|
Active Comparator: Control
Control group will receive treatment as usual in the form of Mutual Help Meetings.
|
Groups based on treatment as usual where patients gather to discuss how they can help others on the ward, and make requests for how others can help them.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inclusion of Other in the Self Scale (IOS)
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
|
|
UCLA Loneliness Scale (ULS-6)
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
|
|
Relational Health Indices (RHI)
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
|
|
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
|
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
|
|
Sacred Moment Qualities (SMQ)
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: Elisabeth VanBussel, MD, 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 23, 2024
Primary Completion (Estimated)
August 25, 2027
Study Completion (Estimated)
September 30, 2027
Study Registration Dates
First Submitted
November 9, 2022
First Submitted That Met QC Criteria
November 9, 2022
First Posted (Actual)
November 17, 2022
Study Record Updates
Last Update Posted (Estimated)
September 24, 2025
Last Update Submitted That Met QC Criteria
September 22, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 12528
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.