## Protocol Section
### Identification Module
**NCT ID:** NCT06424483

**Brief Title:** Love Group for Geriatric Psychiatry Outpatients

**Official Title:** Awareness, Courage, and Love Group Psychotherapy for Geriatric Psychiatry Outpatients

#### Organization Study ID Info
**ID:** 14757
#### Organization
**Class:** OTHER
**Full Name:** Lawson Health Research Institute
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Western University, Canada

#### Lead Sponsor

**Class:** OTHER

**Name:** Lawson Health Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

**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 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 Module

**Conditions:**

- Loneliness

**Keywords:**

- seniors

- mental health

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized waitlist control group

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment

**Intervention Names:**

- Behavioral: Awareness, Courage, and Love Group Psychotherapy

**Label:** Treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Waitlist

**Label:** Waitlist

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment

**Description:** 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.

**Name:** Awareness, Courage, and Love Group Psychotherapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Brief open-ended questions about program satisfaction. Responses are qualitative.

**Measure:** Satisfaction Questionnaire

**Time Frame:** Up to 2 months

#### Primary Outcomes

**Description:** Brief measure of loneliness. The minimum value is 0, the maximum value is 11, and higher scores indicate a worse outcome.

**Measure:** De Jong Gierveld Loneliness Scale

**Time Frame:** Up to 2 months

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

**Measure:** Attendance and attrition

**Time Frame:** Up to 2 months

**Description:** Brief measure of program satisfaction. The minimum value is 0, the maximum value is 16, and higher scores indicate a better outcome.

**Measure:** Quantitative Program Satisfaction

**Time Frame:** Up to 2 months

#### Secondary Outcomes

**Description:** 1 item pictorial scale of subjective wellbeing from 0 (minimum) to 10 (maximum). A higher score indicates a better outcome.

**Measure:** Cantril Self-Anchoring Striving Scale

**Time Frame:** Up to 2 months

**Description:** 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.

**Measure:** Adaptation of Inclusion of Other in Self Scale

**Time Frame:** Up to 2 months

**Description:** Brief measure of group relational health. The minimum value is 8, the maximum value is 40, and higher scores indicate a better outcome.

**Measure:** Relational Health Indices

**Time Frame:** Up to 2 months

**Description:** 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.

**Measure:** Sacred Moment Qualities

**Time Frame:** Up to 2 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** serena.wong@sjhc.london.on.ca

**Name:** Serena Wong, Ph.D.

**Phone:** 5194555110

**Phone Ext:** 48155

**Role:** CONTACT

**Contact 2:**

**Email:** frankie.lui@sjhc.london.on.ca

**Name:** Frankie Lui

**Phone:** 5194555110

**Phone Ext:** 47028

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** St. Joseph's Health Care London

**Name:** Serena Wong, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
