Clinical trial NCT04243018: Feasibility Trial of an Acceptance and Commitment Therapy Intervention for Individuals Experiencing Homelessness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shame
Stigma, Social
Well-Being
Keywords: Shame
Self-Stigma
Homelessness
Well-being
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: On average homeless persons have higher rates of childhood and adult adversity, challenging behaviour, substance and alcohol misuse, poor educational, occupational achievement, co-morbid physical and mental illness. In mental health, services delivered on the basis of address can struggle to mount a satisfactory response to the needs of homeless persons. Many homeless persons rely on emergency department visits or inpatient hospitalizations for health care. When admitted to hospital, they have longer stays with higher costs. With the rates of homelessness increasing in both national and international contexts coupled with the several barriers to accessing mainstream health services, the development of brief, cost-effective interventions, that address comorbidity of various mental illnesses and substance abuse is necessary.

In addition, individuals who have experienced homelessness can have their growth and development curtailed by applying a punitive, shame based, and defeatist perspectives to their own goals and values in life. Direct acts or discrimination, as well as diminished opportunities offered to people experiencing homelessness, can be understood as a manifestation of public stigma. Labelling someone as "homeless" or an "addict" tends to activate common stereotypes such as thinking that the person is likely to be unreliable, deceitful, or weak, among other stereotypes. This often leads to some sort of social sanction or devaluation, reducing the probability of the person being hired, or being trusted as a parent, friend, or lover.

People who identify with a stigmatised group often internalise the stereotypes associated with that group. In addition, the effects of enacted stigma, the emotional and cognitive barriers erected by the individual experiencing homelessness in response to perceived or experienced stigma, can also serve to obstruct access to opportunities. The person may self-identify as a loser, being damaged goods, or always hurting others. Attachment to these self-conceptions entails giving up on important and valued life directions. These are manifestations of self-stigma. Studies of individuals with serious mental illness and co-occurring disorders have shown that self-stigma is associated with delays in treatment seeking or avoidance of treatment, diminished self-esteem/self-efficacy, increased mental health symptoms, and lower quality of life. Therefore, it is imperative that interventions actively address and aim to mitigate the deleterious effects of shame and self-stigma.

Assertive Community Treatment and case-management interventions have been proven moderately effective in improving mental and physical health outcomes for homeless populations, however, the resources and expertise required to run such interventions are; unavailable to most sectors and communities, time consuming and normally used on an individual case basis, leaving large portions of this population untreated. Research into brief psychological interventions with the homeless population has revealed promising effects, however, these interventions often target specific sub-populations, chose to focus on one aspect of recovery such as substance abuse and do not address comorbidity of illness.

The Acceptance and Commitment Therapy(ACT) model is compatible with conceptualisations of recovery from severe mental illness (defined as "living a satisfying, hopeful and contributing life even with limitations caused by the illness"; and "having a sense of purpose and direction"). From an ACT perspective 'addictive-', 'depressive-', 'anxiety'- and "stress-' behaviours might share the same function; and those with high levels of comorbidity, such as the homeless population might therefore be treated using an ACT.

The focus on specific cognitive behavioural processes of mindfulness, acceptance, distancing, and values-based action makes ACT interventions typically brief and have been proven to be effective after a single session and mediation studies suggest that the positive clinical effects of ACT are achieved by changing these targeted psychological processes.

A two-arm feasibility pilot randomised control trial will be conducted to investigate differences in the proposed outcome variables between participants assigned to a group-based ACT intervention and those assigned to peer support group. A process level investigation will also be used to investigate the feasibility of conducting a full scale RCT with the population.

Eligibility 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

Primary outcomes:
measure: Internalised Shame Scale (Cook, 1996)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Self-Stigma Scale- Short (Mak & Cheung, 2010)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: World Health Organisation- Five Well-Being Index (WHO, 1998)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: CompACT Scale (Francis, Dawson, & Moghaddam, 2016)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Identifying Levels of Treatment Engagement
timeFrame: 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Therapist Fidelity and Adherence
timeFrame: 3-months post-baseline (follow-up)
measure: Study Feasibility Interviews
timeFrame: 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Participant Retention and Attrition
timeFrame: Post-completion of data collection an average of one-year
measure: Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson, Hargreaves & Nguyen, 1978)
timeFrame: 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Secondary outcomes:
measure: Cognitive Fusion Questionnaire (Gillanders et al., 2014)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith 1983)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Present Moment Awareness Subscale of the Philadelphia Mindfulness Scale (Cardaciotto, Herbert, Forman, Moitra & Farrow, 2008)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Self-Compassion Scale-Short Form (Raes, pommier, Neff, & Van Gutcht, 2011)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Valuing Questionnaire (Smout, Burns & Christie, 2014)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
measure: Mental Health Continuum - Short Form (Keyes, 2005)
timeFrame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Merchants Quay Ireland
city: Dublin
country: Ireland
facility: Focus Ireland
city: Dublin
country: Ireland
facility: Peter McVerry Trust
Study officials:
affiliation: University College Dublin
name: Louise McHugh, PhD
role: PRINCIPAL_INVESTIGATOR
References: