Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Feb 2024Sep 2027

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 23, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

November 9, 2022

Last Update Submit

September 22, 2025

Conditions

Keywords

lonelinessgeriatricfunctional analytic psychotherapy

Outcome Measures

Primary Outcomes (4)

  • 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.

    Up to 2 months

  • 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.

    Up to 2 months

  • 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.

    Up to 2 months

  • 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.

    Up to 2 months

Secondary Outcomes (2)

  • Cantril Self-Anchoring Striving Scale

    Up to 2 months

  • Sacred Moment Qualities (SMQ)

    Up to 2 months

Other Outcomes (1)

  • Satisfaction Questionnaire

    Up to 2 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: Awareness, Courage, and Love Groups

Control

ACTIVE COMPARATOR

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

Other: Mutual Help Meetings

Interventions

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

Treatment

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.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to geriatric psychiatry inpatient unit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkwood Institute Mental Health

London, Ontario, N6C 0A7, Canada

Location

Study Officials

  • Elisabeth VanBussel, MD

    St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

February 23, 2024

Primary Completion (Estimated)

August 25, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations