ShameNCT04243018
Feasibility Trial of an Acceptance and Commitment Therapy Intervention for Individuals Experiencing Homelessness
A study testing Acceptance and Commitment Therapy Group Treatment and Peer Support Group in people with Shame and Stigma, Social, run by University College Dublin at 3 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shame, Stigma, Social, Well-Being
- What is being tested?
- Acceptance and Commitment Therapy Group Treatment and Peer Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesIreland
- Study dates
- 15 May 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Ireland3 sites
Merchants Quay Ireland
Dublin, D8
Focus Ireland
Dublin
Peter McVerry Trust
Dublin
About this study
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
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.
Read the 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.
- Conditions
- Shame, Stigma, Social, Well-Being
- Being tested
- Acceptance and Commitment Therapy Group Treatment, Peer Support Group
- Keywords
- Shame, Self-Stigma, Homelessness, Well-being
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy Group TreatmentBehavioural
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.
Peer Support GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Peer Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Secondary outcomes (6)
Cognitive Fusion Questionnaire (Gillanders et al., 2014)
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
Measured: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith 1983)
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.
Measured: 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)
10-item self-report questionnaire that measures a key constituent of mindfulness
Measured: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Self-Compassion Scale-Short Form (Raes, pommier, Neff, & Van Gutcht, 2011)
12-item measure that examines the relation of self-compassion to positive psychological health and the five-factor model of personality.
Measured: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Valuing Questionnaire (Smout, Burns & Christie, 2014)
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).
Measured: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Mental Health Continuum - Short Form (Keyes, 2005)
14-item measure of positive mental health consisting of three sub-scales: Emotional well-being, psychological well-being, and social well-being.
Measured: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 May 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShameStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise McHugh, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243018
- Sponsor's protocol ID
- HS19-13Murthy-McHugh
- Status last verified
- Apr 2020
- First submitted
- 24 Sep 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04243018
- Acronym / sponsor ID
- HS19-13Murthy-McHugh
- Conditions
- Shame, Stigma, Social, Well-Being
- Keywords
- Shame, Self-Stigma, Homelessness, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 27 Jan 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment Therapy Group TreatmentAcceptance 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. |
| Peer Support Group | Active comparator | Behavioral: Peer Support GroupThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Acceptance and Commitment Therapy Group TreatmentThe 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. | Behavioural | Acceptance and Commitment Therapy |
| Peer Support GroupThe 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. | Behavioural | Peer Support Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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
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.
6 secondary outcomes
Cognitive Fusion Questionnaire (Gillanders et al., 2014)
Time frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Hospital Anxiety and Depression Scale (HADS; Zigmond, & Snaith 1983)
Time frame: 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)
Time frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
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)
Valuing Questionnaire (Smout, Burns & Christie, 2014)
Time frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Mental Health Continuum - Short Form (Keyes, 2005)
Time frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: Yes
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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.
Louise McHugh, PhD principal investigator
University College Dublin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy Group Treatment and Peer Support Group in people with Shame and Stigma, Social, run by University College Dublin at 3 sites in Ireland.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Internalised Shame Scale (Cook, 1996) (time frame: Baseline; 1-month post-baseline (post-intervention); 3-months post-baseline (follow-up)). The study lists 9 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 2 Apr 2020.