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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243018
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
University College Dublin

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.

Condition or disease Intervention/treatment Phase
Shame Stigma, Social Well-Being Behavioral: Acceptance and Commitment Therapy Group Treatment Behavioral: Peer Support Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Feasibility Pilot Randomised Control Trial for Brief Acceptance and Commitment Therapy (ACT) Intervention for Adults Experiencing Homelessness to Enhance Well-Being and Mitigate the Deleterious Effects of Shame and Self-Stigma
Actual Study Start Date : May 15, 2019
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : January 30, 2020

Arm Intervention/treatment
Experimental: Acceptance and Commitment Therapy
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
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.

Active Comparator: Peer Support Group
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
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.




Primary Outcome Measures :
  1. Internalised Shame Scale (Cook, 1996) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    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.

  2. Self-Stigma Scale- Short (Mak & Cheung, 2010) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    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.

  3. World Health Organisation- Five Well-Being Index (WHO, 1998) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    5-item short self-reported measure of current mental well-being.

  4. CompACT Scale (Francis, Dawson, & Moghaddam, 2016) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    23-item measure assessing Acceptance and Commitment Therapy specific outcomes, psychological flexibility, valued action, openness to experience, and behavioural awareness.

  5. Identifying Levels of Treatment Engagement [ Time Frame: 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    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.

  6. Therapist Fidelity and Adherence [ Time Frame: 3-months post-baseline (follow-up) ]
    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.

  7. Study Feasibility Interviews [ Time Frame: 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    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.

  8. Participant Retention and Attrition [ Time Frame: Post-completion of data collection an average of one-year ]
    Percentage of participants retained at 8-week follow-up. Percentage of participants who attended each session and data collection point

  9. Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson, Hargreaves & Nguyen, 1978) [ Time Frame: 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    8-item self-report statement of satisfaction with health and human services.


Secondary Outcome Measures :
  1. Cognitive Fusion Questionnaire (Gillanders et al., 2014) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    seven items rated on a 7-point scale of 1 (never true) to 7 (always true) designed to measure the relationship a person has with his or her own thoughts and beliefs

  2. Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith 1983) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    A self-report rating scale of 14 items, designed to measure anxiety (HADS-A) and depression (HADS-D), with each subscale consisting of 7 items. It consists of two sub-scales yielding a separate score for anxiety and depression.

  3. Present Moment Awareness Subscale of the Philadelphia Mindfulness Scale (Cardaciotto, Herbert, Forman, Moitra & Farrow, 2008) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    10-item self-report questionnaire that measures a key constituent of mindfulness

  4. Self-Compassion Scale-Short Form (Raes, pommier, Neff, & Van Gutcht, 2011) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    12-item measure that examines the relation of self-compassion to positive psychological health and the five-factor model of personality.

  5. Valuing Questionnaire (Smout, Burns & Christie, 2014) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    10-item measure that assesses the degree of personal values enactment "during the past week." Items are rated on a 7-point scale ranging from 0 (not at all true) to 6 (completely true).

  6. Mental Health Continuum - Short Form (Keyes, 2005) [ Time Frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up) ]
    14-item measure of positive mental health consisting of three sub-scales: Emotional well-being, psychological well-being, and social well-being.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243018


Locations
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Ireland
Merchants Quay Ireland
Dublin, Ireland, D8
Focus Ireland
Dublin, Ireland
Peter McVerry Trust
Dublin, Ireland
Sponsors and Collaborators
University College Dublin
Investigators
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Principal Investigator: Louise McHugh, PhD University College Dublin
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Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT04243018    
Other Study ID Numbers: HS19-13Murthy-McHugh
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will become available post publication of the study. This data will be available indefinitely.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College Dublin:
Shame
Self-Stigma
Homelessness
Well-being