Feasibility Trial of an Acceptance and Commitment Therapy Intervention for Individuals Experiencing Homelessness

NCT04243018 | Completed DMC

• 1 other identifier: HS19-13Murthy-McHugh
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The current project's overall aim is to develop and evaluate the feasibility and preliminary efficacy of an ACT intervention to promote psychological well-being and mitigate the deleterious effects of shame and self-stigma in people experiencing homelessness. This project will advance current knowledge using systematic and empirical methodology to develop and evaluate the benefits of a group-based ACT intervention, which to date has not been explored with this population.

Conditions

Shame; Stigma, Social; Well-Being

Keywords

Shame; Self-Stigma; Homelessness; Well-being

Outcome Measures

Primary Outcomes (9)

• Internalised Shame Scale (Cook, 1996)

  30-item measure that assess shame proneness and internalised shame. It also contains a 6-item self-esteem scale.Respondents must rate each self-statement on a Likert-type scale from 0 to 4, with each number anchored to the words, "Never", "Seldom", "Sometimes", "Often", and "Almost Always", respectively. Higher scores indicate more problematic levels of internalised shame. Higher scores on the self-esteem sub-scale indicate positive self-esteem. Scores of the sub-scales are summed to provide a total score for internalised shame.

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Self-Stigma Scale- Short (Mak & Cheung, 2010)

  a 9-item measure that is conceptualised along three psychological dimensions (viz., self-stigmatising cognition, affect, and behaviour), and corresponds to cognitive-behaviour theory.Each item asks the respondents to rate their agreement on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). Higher score on the SSS-S represents a higher level of self-stigma.

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• World Health Organisation- Five Well-Being Index (WHO, 1998)

  5-item short self-reported measure of current mental well-being.

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• CompACT Scale (Francis, Dawson, & Moghaddam, 2016)

  23-item measure assessing Acceptance and Commitment Therapy specific outcomes, psychological flexibility, valued action, openness to experience, and behavioural awareness.

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Identifying Levels of Treatment Engagement

  Semi-structured interviews will also be conducted with a service user from each group and with service providers, this done in order to assess treatment engagement and also inform a process level investigation.

  1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Therapist Fidelity and Adherence

  Treatment fidelity will be assessed post-intervention by 2 independent reviewers (members of the Contextual Behavioural Sciences lab in UCD). This will involve reviewers listening to the same 10-minute recording from each session and listing the ACT processes they can identify within the 10-minute recording. With the aim of achieving a minimum of 70% consensus between reviewers. Therapists will also have to write down what exercises were used to teach each of the ACT processes post-intervention for each session and will be assessed by the independent reviewers to assess protocol adherence; were all of the ACT processes taught and were the exercises in the protocol used.

  3-months post-baseline (follow-up)

• Study Feasibility Interviews

  Service users will be asked about the practicalities of participating the study (e.g. experience of answering questionnaires), experiences of the group, how the intervention has impacted the environment in the shelter, what they found most beneficial, recommendations for improvements, and engagement with intervention and the use of skills learned.Service provider interviews will explore, feasibility of the intervention, resource management, staff-researcher communication and the intervention. Results from these interviews, therapist adherence and fidelity, and analysis of retention and attrition will be the process-based outcomes from the study.

  1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Participant Retention and Attrition

  Percentage of participants retained at 8-week follow-up. Percentage of participants who attended each session and data collection point

  Post-completion of data collection an average of one-year

• Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson, Hargreaves & Nguyen, 1978)

  8-item self-report statement of satisfaction with health and human services.

  1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

Secondary Outcomes (6)

• Cognitive Fusion Questionnaire (Gillanders et al., 2014)

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith 1983)

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Present Moment Awareness Subscale of the Philadelphia Mindfulness Scale (Cardaciotto, Herbert, Forman, Moitra & Farrow, 2008)

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Self-Compassion Scale-Short Form (Raes, pommier, Neff, & Van Gutcht, 2011)

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

• Valuing Questionnaire (Smout, Burns & Christie, 2014)

  Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Acceptance and Commitment Therapy Intervention to improve well-being and reduce the negative effects of shame and self-stigma in a population of adults experiencing homelessness.This will involve participating in two sessions, lasting two and a half hours each, over a period of two weeks. Well-being will be promoted in each session by targeting core processes of the ACT model including acceptance, cognitive defusion, mindfulness, flexible perspective taking, values clarification and committed action. In addition participants will be provided with an acceptance and commitment training workbook. The workbook will foster core processes of the ACT model through psycho-education, daily exercises, tips and tools.

Behavioral: Acceptance and Commitment Therapy Group Treatment

Peer Support Group

ACTIVE COMPARATOR

This peer support group will involve discussing themes around experiencing homelessness, shame and stigma and will be facilitated by an experienced peer support group leader.This will involve participating in two sessions, lasting two hours each, over a period of two weeks.

Behavioral: Peer Support Group

Interventions

Acceptance and Commitment Therapy Group Treatment BEHAVIORAL

The intervention presents, a mixture of instruction, discussion, and the use of metaphor and experiential activities designed to sensitise participants to the effects of self-stigma and shame on how they live their lives. This training condition provides instruction and experiences that train participants to notice, and then to override, the very human tendency to categorise and then avoid aversive thoughts and feelings and the people and situations that evoke them. The acceptance and commitment training condition will cover the following topics: (a) introduction to enacted and self-stigma (b) cognitive defusion/behavioural flexibility (c) acceptance vs. avoidance and control of emotions and thoughts and (d) values and committed action.

Acceptance and Commitment Therapy

Peer Support Group BEHAVIORAL

The peer support group will allow participants to share and discuss experiences related to their experiences of homelessness, shame and stigma. The group will be facilitated by an expert in facilitating peer support groups with marginalised populations.

Peer Support Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Service Users: Individuals who are currently experiencing or have experienced homelessness in the past year.
• Over 18 and under 65.
• \- Service Providers: Have been working with homeless services for over a year, in close contact with service users. Over 18 and under 65.

You may not qualify if:

• Participants with severe mental health issues- Currently experiencing suicidal ideation or active psychosis
• Participants with serious cognitive impairments
• Participants with below conversational level proficiency in English

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (3)

Merchants Quay Ireland

Dublin, D8, Ireland

Location

Focus Ireland

Dublin, Ireland

Location

Peter McVerry Trust

Dublin, Ireland

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Louise McHugh, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: January 27, 2020
• Study Start: May 15, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available post publication of the study. This data will be available indefinitely.

Locations

IE (3)