DementiaNCT02991183
ACT for Carers of People With Dementia
A study testing ACT in people with Dementia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice and accept difficult thoughts and emotions. ACT also helps people to identify what they value in life (e.g. a good relationship with their partner) and make changes to their behaviour to promote these values. Read more about this study
- Who is it for?
- Ages 18 to 116 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2017to 17 Aug 2017
- 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 116 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- carers of people with a diagnosis of any type of dementia
- primary caregiver of the person with dementia for 3 months or more
- informed consent
- adequate English language skills
Who cannot join
- receiving any type of concurrent psychotherapy
- diagnosis of a severe or acute mental health problem (such as psychosis, anxiety, depression) when consent to participate is sought
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Acceptance and Commitment Therapy (ACT) to Promote the Wellbeing of Carers of People With Dementia
Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice and accept difficult thoughts and emotions. ACT also helps people to identify what they value in life (e.g. a good relationship with their partner) and make changes to their behaviour to promote these values. Carers of people with dementia may experience reduced wellbeing associated with their role. Those whose wellbeing is greater than previously are said to be 'flourishing'.
Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group intervention for carers of people with dementia.
Read more
Methods: Participants will include adult carers of people with dementia. Study participants will be identified from two older people community mental health teams. Informed consent will be sought prior to group invitations being sent out. There will be two groups in total (12 in each group) and both groups will attend three 2.5 hour sessions of ACT. All participants will complete questionnaires at the beginning and 21 days later (asking questions about their thoughts and feelings, flourishing and about being a carer). Eight group participants will be invited to a focus group to understand what they found more helpful and less helpful.
Applications: Results from this study will potentially provide useful information to enable a further study with more participants to be conducted. The outcomes of this study will be shared with older people community mental health teams, dementia and carer specialist groups and potentially published in a relevant journal.
Read the detailed description
Participants: two groups of participants will receive the ACT group intervention (Total n=24; n/Group = 12). One group of participants (n=8) who attend the ACT intervention will be invited to a focus group exploring intervention acceptability.
Recruitment Procedures: prior to recruitment commencing the researcher will present details of the study (recruitment procedures, eligibility criteria etc.) to the relevant Community Mental Health Teams (CMHTs) and at the Older Adult Psychology Team meeting. Carers of People with Dementia (CPwD) will be identified by National Health Service (NHS) staff working in Older People's CMHTs.
Potential participants will receive patient information sheet at routine appointments they attend with the person with dementia for whom they care. Carers will provide permission for their contact details to be passed to the research team using 'Notice of Interest' slip. The researcher will then arrange to meet with the carer to recruit them to the study. Informed consent will be sought and a member of the research team will complete a consent form with participants after they have had time to read the Participant Information Sheet. Consenting participants will be sent appointment letters with further details of the group.
Measures: participants will complete the following measures at the beginning and end of the ACT group intervention:
- Demographic questionnaire (including age, gender, length of time being in a caring role, fulltime or part-time carers, any other employment, number of individuals they care for, and their relationship to the individual they care for (e.g. spouse, sibling, child, other).
- Acceptance and Action Questionnaire: (AAQII). The AAQII is a 7 item questionnaire, which measures psychological flexibility on a 7 point Likert scale.
- Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is a 14 item questionnaire, measuring wellbeing on a 6 point Likert scale.
- Experiential Avoidance in Caregiving Questionnaire (EACQ) The EACQ is a 15 item questionnaire, which measures experiential avoidance on a 5 point Likert scale.
- Caregiver Burden Scale (CBS).The CBS is a 21 item questionnaire, which measures the overall level of burden carers experience in relation to their spouse or relative on a 5 point Likert scale.
- Recruitment and retention parameters: A sample size of at least 12 people per group for pilot pharmaceutical studies will be an indicator of sufficient recruitment. However, 8 has been suggested as the optimum number of group participants in psychological interventions. Therefore, a figure of no more than 33% attrition from baseline to final assessment will be used to indicate that the ACT group intervention is feasible in terms of retention.
- Group Evaluation Form: A brief survey will be completed with Likert scales and free text boxes for reflections on participants experience of attending the ACT groups.
- Focus group: A smaller number of participants (n = 8) will also be invited to attend a focus group to explore their view of taking part in the ACT groups. This will be audio-recorded and transcribed for analysis.
Design: this project will be an uncontrolled feasibility trial, using convenience sampling, and measuring a range of variables pertinent to the feasibility of delivering ACT intervention groups for CPwD. Process evaluation methodology, including quantitative and qualitative methods, will be applied to measure feasibility of the group intervention and develop a greater understanding of the intervention delivered and its causal assumptions (see research questions above).
Quantitative data collected will include demographic information, number of participants recruited and retained throughout the study, outcome measures (carer burden, psychological flexibility, flourishing), and responses to Likert scale acceptability questions. Qualitative data will include responses to open-ended acceptability questions in the format of a questionnaire and focus group exploring participants' experience of attending the groups.
Research Procedures Measures will be completed by all participants at baseline (beginning of group) and 21 days post-baseline (end of group). Baseline measures will be completed prior to the first session. Post-baseline measures will be completed following the third session. Feedback surveys will be given to all participants at the last group session with Likert scales and free text boxes for reflections on their experience of attending the ACT groups.
A focus group of 8 participants who have completed the ACT group intervention will be conducted by a facilitator independent from the ACT group facilitators. The participants will be selected to provide a range of experiences of the group to elicit rich discussion and qualitative data regarding acceptability. A semi-structured interview will be used to guide discussions (including open questions related to group format and structure, ACT approach, practicalities of attending) but the participants will be encouraged to openly discuss their opinions of their experience of the ACT group.
- Conditions
- Dementia
- Being tested
- ACT
- Keywords
- Caregivers, Acceptance and Commitment Therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
A psychological therapy to help people i) notice and accept difficult thoughts and emotions; ii) identify what they value in life and iii) make changes to their behaviour to promote these values.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Two half day (2.5 hours) group ACT sessions delivered one week apart followed by a third session 2 weeks following the second session. Receives: Behavioral: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited and retained to study completion
Measured: 4 weeks
Well-being
Change in score from Mental Health Continuum Short Form questionnaire
Measured: Time 0 and week 4
Acceptability
Qualitative responses to Acceptability questionnaire devised by research team
Measured: 4 weeks
Fidelity
Fidelity of the intervention to the ACT approach (measure developed by research team)
Measured: 4 weeks
Secondary outcomes (3)
Psychological Flexibility
Change in score from Acceptance and Action Questionnaire-II
Measured: Time 0 and week 4
Psychological Flexibility in Caregivers
Change in score from Experiential Avoidance in Caregiving Questionnaire
Measured: Time 0 and week 4
Caregiver Burden
Change in score from Caregiver Burden Scale
Measured: Time 0 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start17 Feb 2017
- Primary completion21 Apr 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Hamish McLeod, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991183
- Sponsor's protocol ID
- GN16MH672
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Acceptance and Commitment Therapy (ACT) to Promote the Wellbeing of Carers of People With Dementia
- ClinicalTrials.gov ID
- NCT02991183
- Acronym / sponsor ID
- GN16MH672
- Conditions
- Dementia
- Keywords
- Caregivers, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice and accept difficult thoughts and emotions. ACT also helps people to identify what they value in life (e.g. a good relationship with their partner) and make changes to their behaviour to promote these values. Carers of people with dementia may experience reduced wellbeing associated with their role. Those whose wellbeing is greater than previously are said to be 'flourishing'.
Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group intervention for carers of people with dementia.
Methods: Participants will include adult carers of people with dementia. Study participants will be identified from two older people community mental health teams. Informed consent will be sought prior to group invitations being sent out. There will be two groups in total (12 in each group) and both groups will attend three 2.5 hour sessions of ACT. All participants will complete questionnaires at the beginning and 21 days later (asking questions about their thoughts and feelings, flourishing and about being a carer). Eight group participants will be invited to a focus group to understand what they found more helpful and less helpful.
Applications: Results from this study will potentially provide useful information to enable a further study with more participants to be conducted. The outcomes of this study will be shared with older people community mental health teams, dementia and carer specialist groups and potentially published in a relevant journal.
Detailed description
Participants: two groups of participants will receive the ACT group intervention (Total n=24; n/Group = 12). One group of participants (n=8) who attend the ACT intervention will be invited to a focus group exploring intervention acceptability.
Recruitment Procedures: prior to recruitment commencing the researcher will present details of the study (recruitment procedures, eligibility criteria etc.) to the relevant Community Mental Health Teams (CMHTs) and at the Older Adult Psychology Team meeting. Carers of People with Dementia (CPwD) will be identified by National Health Service (NHS) staff working in Older People's CMHTs.
Potential participants will receive patient information sheet at routine appointments they attend with the person with dementia for whom they care. Carers will provide permission for their contact details to be passed to the research team using 'Notice of Interest' slip. The researcher will then arrange to meet with the carer to recruit them to the study. Informed consent will be sought and a member of the research team will complete a consent form with participants after they have had time to read the Participant Information Sheet. Consenting participants will be sent appointment letters with further details of the group.
Measures: participants will complete the following measures at the beginning and end of the ACT group intervention:
- Demographic questionnaire (including age, gender, length of time being in a caring role, fulltime or part-time carers, any other employment, number of individuals they care for, and their relationship to the individual they care for (e.g. spouse, sibling, child, other).
- Acceptance and Action Questionnaire: (AAQII). The AAQII is a 7 item questionnaire, which measures psychological flexibility on a 7 point Likert scale.
- Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is a 14 item questionnaire, measuring wellbeing on a 6 point Likert scale.
- Experiential Avoidance in Caregiving Questionnaire (EACQ) The EACQ is a 15 item questionnaire, which measures experiential avoidance on a 5 point Likert scale.
- Caregiver Burden Scale (CBS).The CBS is a 21 item questionnaire, which measures the overall level of burden carers experience in relation to their spouse or relative on a 5 point Likert scale.
- Recruitment and retention parameters: A sample size of at least 12 people per group for pilot pharmaceutical studies will be an indicator of sufficient recruitment. However, 8 has been suggested as the optimum number of group participants in psychological interventions. Therefore, a figure of no more than 33% attrition from baseline to final assessment will be used to indicate that the ACT group intervention is feasible in terms of retention.
- Group Evaluation Form: A brief survey will be completed with Likert scales and free text boxes for reflections on participants experience of attending the ACT groups.
- Focus group: A smaller number of participants (n = 8) will also be invited to attend a focus group to explore their view of taking part in the ACT groups. This will be audio-recorded and transcribed for analysis.
Design: this project will be an uncontrolled feasibility trial, using convenience sampling, and measuring a range of variables pertinent to the feasibility of delivering ACT intervention groups for CPwD. Process evaluation methodology, including quantitative and qualitative methods, will be applied to measure feasibility of the group intervention and develop a greater understanding of the intervention delivered and its causal assumptions (see research questions above).
Quantitative data collected will include demographic information, number of participants recruited and retained throughout the study, outcome measures (carer burden, psychological flexibility, flourishing), and responses to Likert scale acceptability questions. Qualitative data will include responses to open-ended acceptability questions in the format of a questionnaire and focus group exploring participants' experience of attending the groups.
Research Procedures Measures will be completed by all participants at baseline (beginning of group) and 21 days post-baseline (end of group). Baseline measures will be completed prior to the first session. Post-baseline measures will be completed following the third session. Feedback surveys will be given to all participants at the last group session with Likert scales and free text boxes for reflections on their experience of attending the ACT groups.
A focus group of 8 participants who have completed the ACT group intervention will be conducted by a facilitator independent from the ACT group facilitators. The participants will be selected to provide a range of experiences of the group to elicit rich discussion and qualitative data regarding acceptability. A semi-structured interview will be used to guide discussions (including open questions related to group format and structure, ACT approach, practicalities of attending) but the participants will be encouraged to openly discuss their opinions of their experience of the ACT group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: ACTTwo half day (2.5 hours) group ACT sessions delivered one week apart followed by a third session 2 weeks following the second session. |
Who may qualify
- Ages
- 18 to 116 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- carers of people with a diagnosis of any type of dementia
- primary caregiver of the person with dementia for 3 months or more
- informed consent
- adequate English language skills
Key exclusion criteria (2 listed)
- receiving any type of concurrent psychotherapy
- diagnosis of a severe or acute mental health problem (such as psychosis, anxiety, depression) when consent to participate is sought
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 |
|---|---|---|
| ACTA psychological therapy to help people i) notice and accept difficult thoughts and emotions; ii) identify what they value in life and iii) make changes to their behaviour to promote these values. | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
Number of participants recruited and retained to study completion
Time frame: 4 weeks
Well-being
Time frame: Time 0 and week 4
Change in score from Mental Health Continuum Short Form questionnaire
Acceptability
Time frame: 4 weeks
Qualitative responses to Acceptability questionnaire devised by research team
Fidelity
Time frame: 4 weeks
Fidelity of the intervention to the ACT approach (measure developed by research team)
3 secondary outcomes
Psychological Flexibility
Time frame: Time 0 and week 4
Psychological Flexibility in Caregivers
Time frame: Time 0 and week 4
Caregiver Burden
Time frame: Time 0 and week 4
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 22 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Hamish McLeod, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Dementia, run by NHS Greater Glasgow and Clyde 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 4 inclusion and 2 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 22 Aug 2017. 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?
Number of participants recruited and retained to study completion (time frame: 4 weeks). The study lists 4 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 22 Aug 2017.