Intellectual DisabilityNCT05339191
Compassionate Imagery for People With An Intellectual Disability
A study testing Compassionate image workshop in people with Intellectual Disability, run by NHS Lanarkshire at 1 site in United Kingdom.
Trial summary
The current study aims to explore the adaptation of compassionate imagery for people with an intellectual disability who are experiencing mental health difficulties. It will explore whether participants are able to generate and use their own compassionate image, as well as exploring the participants' views of engaging… Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Compassionate image workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2020to 30 Apr 2021
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Open to NHS Lanarkshire's Community Learning Disability Team (CLDT) and will therefore be aged 16 or above
- Experiencing mental health difficulties
Who cannot join
- Do not have capacity to provide informed consent
- Have insufficient communication skills to engage with the tasks
- Have sensory impairments which are likely to inhibit their ability to engage with the study materials
- Actively suicidal
- Likely to be disruptive or distressed in a group setting
- Known to have previously engaged in a piece of therapeutic work involving the development of a compassionate image
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kilsyth Community Centre
Kilsyth, Lanarkshire, G65 4JE
About this study
Official title: A Brief Compassionate Imagery Intervention for People With an Intellectual Disability: A Case Series in a Clinical Setting
The current study aims to explore the adaptation of compassionate imagery for people with an intellectual disability who are experiencing mental health difficulties. It will explore whether participants are able to generate and use their own compassionate image, as well as exploring the participants' views of engaging in the workshop. It is an early exploratory study in what is hoped will be a longer process consisting of future feasibility and piloting work.
Between 6-10 participants who are attending the National Health Service (NHS) NHS Lanarkshire Community Learning Disability Team and are experiencing mental health difficulties will be recruited. Participants will be asked to attend a two-session workshop through which they will be supported to develop and use their own compassionate image. The research questions will be answered by obtaining descriptive data from data recording sheets completed during the sessions and by interviewing participants about their experiences of the workshop.
Read the detailed description
People with an intellectual disability experience widespread stigma, mistreatment and abuse (Scior and Werner, 2016, Gravell, 2012, Hughes et al., 2012, Jones et al., 2012). These are likely to lead individuals to experience shame and self-criticism, which can contribute to the development of mental health difficulties. Indeed, many people with an intellectual disability do experience mental health difficulties (Buckles et al., 2013).
Compassion-Focused Therapy (CFT) is a psychological therapy which aims to reduce shame and self-criticism by developing a person's ability to feel compassion. It involves enabling individuals to learn to soothe themselves when they feel distressed. Compassionate imagery is one CFT technique used to do this (Gilbert, 2009). This can involve developing a mental image of a compassionate person or animal who is wise, strong, warm and non-judgemental.
The individual is encouraged to explore their experience of imagining this, which may include feeling a sense of safety, warmth and connectedness (Gilbert, 2015).
The current study aims to explore the adaptation of compassionate imagery for people with an intellectual disability who are experiencing mental health difficulties. It will explore whether participants are able to generate and use their own compassionate image, as well as exploring the participants' views of engaging in the workshop. It is an early exploratory study in what is hoped will be a longer process consisting of future feasibility and piloting work.
Between 6-10 participants who are attending the NHS Lanarkshire Community Learning Disability Team and are experiencing mental health difficulties will be recruited. Participants will be asked to attend a two-session workshop through which they will be supported to develop and use their own compassionate image. The research questions will be answered by obtaining descriptive data from data recording sheets completed during the sessions and by interviewing participants about their experiences of the workshop.
- Conditions
- Intellectual Disability
- Being tested
- Compassionate image workshop
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassionate image workshopBehavioural
Participants attend a workshop through which they will be supported to develop and use their own compassionate image.
| Study group | Role | What they receive |
|---|---|---|
| Compassionate image workshop | Experimental | Participants attend a workshop through which they will be supported to develop and use their own compassionate image. Receives: Behavioral: Compassionate image workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compassionate image
Number of participants that are able to generate their own compassionate image
Measured: 6 months
Secondary outcomes (1)
Self-soothing
Number of participants that report using their compassionate image to self-soothe outside of sessions and the number that find this to be helpful.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Jul 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants who are attending the NHS Lanarkshire Community Learning Disability Team and are experiencing mental health difficulties will be recruited. Participants will be asked to attend a two-session workshop through which they will be supported to develop and use their own compassionate image. The research questions will be answered by obtaining descriptive data from data recording sheets completed during the sessions and by interviewing participants about their experiences of the workshop.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lanarkshire
- Sponsor type
- Other government
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Miriam Holm, Principal investigator, NHS Lanarkshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339191
- Sponsor's protocol ID
- L19092
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None will be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Compassionate Imagery Intervention for People With an Intellectual Disability: A Case Series in a Clinical Setting
- ClinicalTrials.gov ID
- NCT05339191
- Acronym / sponsor ID
- L19092
- Conditions
- Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NHS LanarkshireOther government
- Collaborators
- University of Glasgow
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 21 Apr 2022 (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 study aims to explore the adaptation of compassionate imagery for people with an intellectual disability who are experiencing mental health difficulties. It will explore whether participants are able to generate and use their own compassionate image, as well as exploring the participants' views of engaging in the workshop. It is an early exploratory study in what is hoped will be a longer process consisting of future feasibility and piloting work.
Between 6-10 participants who are attending the National Health Service (NHS) NHS Lanarkshire Community Learning Disability Team and are experiencing mental health difficulties will be recruited. Participants will be asked to attend a two-session workshop through which they will be supported to develop and use their own compassionate image. The research questions will be answered by obtaining descriptive data from data recording sheets completed during the sessions and by interviewing participants about their experiences of the workshop.
Detailed description
People with an intellectual disability experience widespread stigma, mistreatment and abuse (Scior and Werner, 2016, Gravell, 2012, Hughes et al., 2012, Jones et al., 2012). These are likely to lead individuals to experience shame and self-criticism, which can contribute to the development of mental health difficulties. Indeed, many people with an intellectual disability do experience mental health difficulties (Buckles et al., 2013).
Compassion-Focused Therapy (CFT) is a psychological therapy which aims to reduce shame and self-criticism by developing a person's ability to feel compassion. It involves enabling individuals to learn to soothe themselves when they feel distressed. Compassionate imagery is one CFT technique used to do this (Gilbert, 2009). This can involve developing a mental image of a compassionate person or animal who is wise, strong, warm and non-judgemental.
The individual is encouraged to explore their experience of imagining this, which may include feeling a sense of safety, warmth and connectedness (Gilbert, 2015).
The current study aims to explore the adaptation of compassionate imagery for people with an intellectual disability who are experiencing mental health difficulties. It will explore whether participants are able to generate and use their own compassionate image, as well as exploring the participants' views of engaging in the workshop. It is an early exploratory study in what is hoped will be a longer process consisting of future feasibility and piloting work.
Between 6-10 participants who are attending the NHS Lanarkshire Community Learning Disability Team and are experiencing mental health difficulties will be recruited. Participants will be asked to attend a two-session workshop through which they will be supported to develop and use their own compassionate image. The research questions will be answered by obtaining descriptive data from data recording sheets completed during the sessions and by interviewing participants about their experiences of the workshop.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants who are attending the NHS Lanarkshire Community Learning Disability Team and are experiencing mental health difficulties will be recruited. Participants will be asked to attend a two-session workshop through which they will be supported to develop and use their own compassionate image. The research questions will be answered by obtaining descriptive data from data recording sheets completed during the sessions and by interviewing participants about their experiences of the workshop.
| Arm | Type | Receives |
|---|---|---|
| Compassionate image workshop | Experimental | Behavioral: Compassionate image workshopParticipants attend a workshop through which they will be supported to develop and use their own compassionate image. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Open to NHS Lanarkshire's Community Learning Disability Team (CLDT) and will therefore be aged 16 or above
- Experiencing mental health difficulties
Key exclusion criteria (6 listed)
- Do not have capacity to provide informed consent
- Have insufficient communication skills to engage with the tasks
- Have sensory impairments which are likely to inhibit their ability to engage with the study materials
- Actively suicidal
- Likely to be disruptive or distressed in a group setting
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 |
|---|---|---|
| Compassionate image workshopParticipants attend a workshop through which they will be supported to develop and use their own compassionate image. | Behavioural | Compassionate image workshop |
Primary outcome
Compassionate image
Time frame: 6 months
Number of participants that are able to generate their own compassionate image
1 secondary outcome
Self-soothing
Time frame: 6 months
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 21 Apr 2022.
- Individual participant dataSharing planned: No. None will be shared
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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.
Miriam Holm principal investigator
NHS Lanarkshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassionate image workshop in people with Intellectual Disability, run by NHS Lanarkshire at 1 site in United Kingdom.
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 2 inclusion and 6 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Compassionate image (time frame: 6 months). 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 21 Apr 2022.