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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424483
Other study ID # 14757
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source Lawson Health Research Institute
Contact Serena Wong, Ph.D.
Phone 5194555110
Email serena.wong@sjhc.london.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 our clinical trial is to adapt, implement, and evaluate the ACL group for outpatients.


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 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?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 30, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Awareness, Courage, and Love Group 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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Lawson Health Research Institute Western University, Canada

Outcome

Type Measure Description Time frame Safety issue
Other Satisfaction Questionnaire Brief open-ended questions about program satisfaction. Responses are qualitative. Up to 2 months
Primary 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
Primary Attendance and attrition Measure of feasibility. Captured across 8 sessions, comparing pre to post. Up to 2 months
Primary 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 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. Up to 2 months
Secondary Adaptation of Inclusion of Other in Self Scale 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
Secondary Relational Health Indices 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
Secondary Sacred Moment Qualities 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
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