LonelinessNCT06424483
Love Group for Geriatric Psychiatry Outpatients
A study testing Awareness, Courage, and Love Group Psychotherapy 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
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. 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 Group Psychotherapy
- 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
- 1 Feb 2025to 30 Dec 2028
- 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
- Older adults with psychiatric disorder(s)
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
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awareness, Courage, and Love Group Psychotherapy for Geriatric Psychiatry Outpatients
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.
Read the detailed description
The objective of this 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?
- Conditions
- Loneliness
- Being tested
- Awareness, Courage, and Love Group Psychotherapy
- Keywords
- seniors, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awareness, Courage, and Love Group PsychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Group psychotherapy | Experimental | Treatment group receiving psychotherapy Receives: Behavioral: Awareness, Courage, and Love Group Psychotherapy |
| Waitlist | No intervention | Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
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.
Measured: Up to 2 months
Secondary outcomes (4)
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
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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.
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 posted22 May 2024
- Study start1 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Dec 2028 (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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Model description
- Randomized waitlist control group
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424483
- Sponsor's protocol ID
- 14757
- Status last verified
- Jan 2026
- First submitted
- 16 May 2024
- Last updated
- 28 Jan 2026
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness, Courage, and Love Group Psychotherapy for Geriatric Psychiatry Outpatients
- ClinicalTrials.gov ID
- NCT06424483
- Acronym / sponsor ID
- 14757
- Conditions
- Loneliness
- Keywords
- seniors, mental health
- 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
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 May 2024 (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.
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.
Detailed description
The objective of this 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized waitlist control group
| Arm | Type | Receives |
|---|---|---|
| Treatment: Group psychotherapy | Experimental | Behavioral: Awareness, Courage, and Love Group PsychotherapyTreatment group receiving psychotherapy |
| Waitlist | No intervention | –Waitlist control |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older adults with psychiatric disorder(s)
Key exclusion criteria (2 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
- Unable to speak English
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 Group PsychotherapyAwareness, 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. | Behavioural | Treatment: Group psychotherapy |
Primary outcome
De Jong Gierveld Loneliness Scale
Time frame: Up to 2 months
Brief measure of loneliness. The minimum value is 0, the maximum value is 11, and higher scores indicate a worse outcome.
Attendance and attrition (defined as the number of participants that withdraw (numerator)/number of participants randomised (denominator))
Time frame: Up to 2 months
Measure of feasibility. Captured across 8 sessions, comparing pre to post.
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.
UCLA Loneliness Scale (Neto)
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.
4 secondary outcomes
Cantril Self-Anchoring Striving Scale
Time frame: Up to 2 months
Adaptation of Inclusion of Other in Self Scale
Time frame: Up to 2 months
Relational Health Indices
Time frame: Up to 2 months
Sacred Moment Qualities
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 28 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Group Psychotherapy 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 2 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 28 Jan 2026. 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?
De Jong Gierveld Loneliness Scale (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 28 Jan 2026.