LonelinessNCT05619718
Loneliness Group Intervention
A study testing Awareness, Courage, and Love Groups and Mutual Help Meetings in people with Loneliness, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Loneliness
- What is being tested?
- Awareness, Courage, and Love Groups and Mutual Help Meetings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to geriatric psychiatry inpatient unit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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?
- Conditions
- Loneliness
- Being tested
- Awareness, Courage, and Love Groups, Mutual Help Meetings
- Keywords
- loneliness, geriatric, functional analytic psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awareness, Courage, and Love GroupsBehavioural
Groups based on the Awareness, Courage, and Love framework from functional analytic psychotherapy
Mutual Help MeetingsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment group will receive Awareness, Courage, and Love Groups for loneliness. Receives: Behavioral: Awareness, Courage, and Love Groups |
| Control | Active comparator | Control group will receive treatment as usual in the form of Mutual Help Meetings. Receives: Other: Mutual Help Meetings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 months
Secondary outcomes (2)
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start23 Feb 2024
- Primary completion25 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada
- Responsible party
- Sponsor
- Investigators
- Elisabeth VanBussel, MD, Principal investigator, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619718
- Sponsor's protocol ID
- 12528
- Status last verified
- Sep 2025
- First submitted
- 9 Nov 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loneliness Group Intervention for Geriatric Psychiatry Inpatients
- ClinicalTrials.gov ID
- NCT05619718
- Acronym / sponsor ID
- 12528
- Conditions
- Loneliness
- Keywords
- loneliness, geriatric, functional analytic psychotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canada
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Awareness, Courage, and Love GroupsTreatment group will receive Awareness, Courage, and Love Groups for loneliness. |
| Control | Active comparator | Other: Mutual Help MeetingsControl group will receive treatment as usual in the form of Mutual Help Meetings. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to geriatric psychiatry inpatient unit
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awareness, Courage, and Love GroupsGroups based on the Awareness, Courage, and Love framework from functional analytic psychotherapy | Behavioural | Treatment |
| Mutual Help MeetingsGroups 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. | Other | Control |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Cantril Self-Anchoring Striving Scale
Time frame: Up to 2 months
Sacred Moment Qualities (SMQ)
Time frame: Up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth VanBussel, MD principal investigator
St. Joseph's Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awareness, Courage, and Love Groups and Mutual Help Meetings in people with Loneliness, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclusion of Other in the Self Scale (IOS) (time frame: Up to 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.