NCT06424483

Brief Summary

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.

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
33mo left

Started Feb 2025

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

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Study Timeline

Key milestones and dates

Study Progress32%
Feb 2025Dec 2028

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

May 16, 2024

Last Update Submit

January 26, 2026

Conditions

Loneliness

Keywords

seniorsmental health

Outcome Measures

Primary Outcomes (4)

  • De Jong Gierveld Loneliness Scale

    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))

    Measure of feasibility. Captured across 8 sessions, comparing pre to post.

    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

  • UCLA Loneliness Scale (Neto)

    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 Outcomes (4)

  • Cantril Self-Anchoring Striving Scale

    Up to 2 months

  • Adaptation of Inclusion of Other in Self Scale

    Up to 2 months

  • Relational Health Indices

    Up to 2 months

  • Sacred Moment Qualities

    Up to 2 months

Other Outcomes (1)

  • Satisfaction Questionnaire

    Up to 2 months

Study Arms (2)

Treatment: Group psychotherapy

EXPERIMENTAL

Treatment group receiving psychotherapy

Behavioral: Awareness, Courage, and Love Group Psychotherapy

Waitlist

NO INTERVENTION

Waitlist control

Interventions

Awareness, Courage, and Love Group PsychotherapyBEHAVIORAL

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.

Treatment: Group psychotherapy

Eligibility Criteria

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

You may qualify if:

  • Older adults with psychiatric disorder(s)

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
  • Unable to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6C0A7, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized waitlist control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 30, 2028

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)