CClinicalTrials.gg
Active, not recruitingNCT05619718Updated Sep 24, 2025

Loneliness Group Intervention

An interventional study of Awareness, Courage, and Love Groups and Mutual Help Meetings in Loneliness, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Active, not recruiting at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study summary

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.

Read the 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?

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Conditions studied

  • Loneliness

Keywords

  • loneliness
  • geriatric
  • functional analytic psychotherapy
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In context

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Admission to geriatric psychiatry inpatient unit

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Treatment

    Treatment group will receive Awareness, Courage, and Love Groups for loneliness.

    Behavioral: Awareness, Courage, and Love Groups

  • Active comparator
    Control

    Control group will receive treatment as usual in the form of Mutual Help Meetings.

    Other: Mutual Help Meetings

Interventions

  • BehavioralAwareness, Courage, and Love Groups

    Groups based on the Awareness, Courage, and Love framework from functional analytic psychotherapy

  • OtherMutual 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.

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What researchers measure

Primary outcomes

  1. Inclusion of Other in the Self Scale (IOS)

    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.

    Time frame: Up to 2 months

  2. UCLA Loneliness Scale (ULS-6)

    Brief measure of loneliness. The minimum value is 6, the maximum value is 24, and higher scores indicate a worse outcome.

    Time frame: Up to 2 months

  3. Relational Health Indices (RHI)

    Brief measure of group relational health. The minimum value is 8, the maximum value is 40, and higher scores indicate a better outcome.

    Time frame: Up to 2 months

  4. Quantitative Program Satisfaction

    Brief measure of program satisfaction. The minimum value is 0, the maximum value is 16, and higher scores indicate a better outcome.

    Time frame: Up to 2 months

Secondary outcomes

  1. Cantril Self-Anchoring Striving Scale

    1 item pictorial scale of subjective wellbeing from 0 (minimum) to 10 (maximum). A higher score indicates a better outcome.

    Time frame: Up to 2 months

  2. Sacred Moment Qualities (SMQ)

    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.

    Time frame: Up to 2 months

Other outcomes

  1. Satisfaction Questionnaire

    Brief open-ended questions about program satisfaction. Responses are qualitative.

    Time frame: Up to 2 months

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Study locations

1 site
  • Parkwood Institute Mental Health
    London, Ontario N6C 0A7, Canada
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References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 5, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05619718
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborators
Western University, Canada
Responsible party
Sponsor
First posted
Nov 17, 2022
Start date
Feb 23, 2024
Primary completion
Aug 25, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 24, 2025

Study contacts

Elisabeth VanBussel, MD
principal investigator · St. Joseph's Health Care London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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