Acceptance and Commitment TherapyNCT04630912
ACT for People With Dementia Experiencing Psychological Distress
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy and Dementia, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Introduction: People with dementia have a high prevalence of psychological distress but are under-served with evidence-based psychological interventions. To promote choice and improve clinical outcomes, there is a necessity to test different psychological intervention options for this population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acceptance and Commitment Therapy, Dementia
- What is being tested?
- Acceptance and Commitment Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2021to 22 Jul 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants were included in the study if they had:
- A clinical diagnosis of dementia (any type)
- A clinically significant level of psychological distress (a score of ≥8 on the GAD-7 and ≥10 on the PHQ-9).
- Ability to give informed consent
- Participants were included in the study if they:
- Cared for someone with a clinical diagnosis of dementia (any type)
Show all 9Show fewer
- Were paid or unpaid and regularly supported them with activities of daily living
- Aged 18+ (no maximum age limit)
- Able to give informed consent
Who cannot join
- Participants were excluded if they:
- Were already receiving psychotherapy
- Had insufficient English or language abilities to engage in therapy
- Were unable to consent to and/or engage in therapy
- Participants were excluded if they:
- Had insufficient English or language abilities to support the person with dementia or engage in study/Change Interviews
- Were unable to consent to and/or engage in study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Community Mental Health Team for Older People
Newark, Nottinghamshire
About this study
Official title: Acceptance and Commitment Therapy (ACT) for People With Dementia Experiencing Psychological Distress: a Hermeneutic Single Case Efficacy Design (HSCED) Series
Introduction: People with dementia have a high prevalence of psychological distress but are under-served with evidence-based psychological interventions. To promote choice and improve clinical outcomes, there is a necessity to test different psychological intervention options for this population. Purpose: To investigate the effectiveness and acceptability of Acceptance and Commitment Therapy (ACT) for people with dementia, considering carer-supported, remote delivery and necessary therapy adaptations. Methods: A hermeneutic single case efficacy design (HSCED) series was used to analyse therapy process and change for three clients with dementia and psychological distress. Quantitative and qualitative data was collated ('rich case records') and analysed by three independent psychotherapy experts ('judges') who determined the outcome for each client. Results: Over the course of therapy, it was concluded that one client with dementia made positive changes, specifically reliable reductions in psychological distress, which were largely attributable to Acceptance and Commitment Therapy (ACT). Two clients remained unchanged. Discussion/Conclusion: Where change was achieved, the ACT-specific processes of values, committed action and acceptance, in combination with non-specific therapy factors including a strong client-carer relationship, existing client interests and individualised therapy adaptations, were facilitative of change. Hence, ACT may be feasible and effective by helping carers to better meet the needs of their loved ones with dementia. Future research to optimise ACT delivery in this population may be beneficial. Furthermore, the assessment of carer factors (e.g., their psychological flexibility, the client-carer relationship) may strengthen the evidence-base for systemic ACT-use.
- Conditions
- Acceptance and Commitment Therapy, Dementia
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Dementia, Psychological distress, Psychological therapy, ACT, Acceptability, HSCED
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyOther
There is no specific protocol for ACT with dementia, therefore a published ACT protocol, 'Better Living with Illness' (Brassington et al., 2016), will be used flexibly to guide the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | 12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6) Receives: Other: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
Generalised anxiety disorder questionnaire (GAD-7), scored 0-21, where higher scores indicate a greater severity of anxiety.
Measured: Through study completion, up to 24 weeks
Change in depression
Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.
Measured: Through study completion, up to 24 weeks
Secondary outcomes (4)
Change in psychological flexibility
Comprehensive assessment of Acceptance \& Commitment Therapy (CompACT-SF), scored 0-48, where higher scores indicate increased psychological flexibility.
Measured: Through study completion, up to 24 weeks
Change in wellbeing
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.
Measured: Through study completion, up to 24 weeks
Change in client problems
Personal questionnaire (PQ), where higher scores indicate greater severity of problems.
Measured: Through study completion, up to 24 weeks
Change in therapeutic alliance
Session rating scale (SRS), does not involve numerical values but asks clients to mark on a line nearest to the description that best fits their experience (marks further towards the right indicate better therapeutic alliance).
Measured: Through study completion, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start20 Jan 2021
- Primary completion14 Oct 2021
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance and Commitment TherapyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Hermeneutic single case efficacy design (HSCED) series
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Danielle De Boos, Dr, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630912
- Sponsor's protocol ID
- 20064
- Status last verified
- Aug 2022
- First submitted
- 2 Nov 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data was written up as part of the student Doctoral Thesis and will be submitted in partial fulfilment of the requirements for the Trent Doctorate in Clinical Psychology (DClinPsy) in February 2022. Participants chose a pseudonym for themselves to be used in publications (e.g. electronic documents, written notes and transcripts) to prevent identification and references to personal information (e.g. other people's names, locations) were altered.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy (ACT) for People With Dementia Experiencing Psychological Distress: a Hermeneutic Single Case Efficacy Design (HSCED) Series
- ClinicalTrials.gov ID
- NCT04630912
- Acronym / sponsor ID
- 20064
- Conditions
- Acceptance and Commitment Therapy, Dementia
- Keywords
- Dementia, Psychological distress, Psychological therapy, ACT, Acceptability, HSCED
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 16 Nov 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.
Introduction: People with dementia have a high prevalence of psychological distress but are under-served with evidence-based psychological interventions. To promote choice and improve clinical outcomes, there is a necessity to test different psychological intervention options for this population. Purpose: To investigate the effectiveness and acceptability of Acceptance and Commitment Therapy (ACT) for people with dementia, considering carer-supported, remote delivery and necessary therapy adaptations. Methods: A hermeneutic single case efficacy design (HSCED) series was used to analyse therapy process and change for three clients with dementia and psychological distress. Quantitative and qualitative data was collated ('rich case records') and analysed by three independent psychotherapy experts ('judges') who determined the outcome for each client. Results: Over the course of therapy, it was concluded that one client with dementia made positive changes, specifically reliable reductions in psychological distress, which were largely attributable to Acceptance and Commitment Therapy (ACT). Two clients remained unchanged. Discussion/Conclusion: Where change was achieved, the ACT-specific processes of values, committed action and acceptance, in combination with non-specific therapy factors including a strong client-carer relationship, existing client interests and individualised therapy adaptations, were facilitative of change. Hence, ACT may be feasible and effective by helping carers to better meet the needs of their loved ones with dementia. Future research to optimise ACT delivery in this population may be beneficial. Furthermore, the assessment of carer factors (e.g., their psychological flexibility, the client-carer relationship) may strengthen the evidence-base for systemic ACT-use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hermeneutic single case efficacy design (HSCED) series
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Other: Acceptance and Commitment Therapy12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- A clinical diagnosis of dementia (any type)
- A clinically significant level of psychological distress (a score of ≥8 on the GAD-7 and ≥10 on the PHQ-9).
- Ability to give informed consent
- Cared for someone with a clinical diagnosis of dementia (any type)
- Were paid or unpaid and regularly supported them with activities of daily living
Key exclusion criteria (7 listed)
- Were already receiving psychotherapy
- Had insufficient English or language abilities to engage in therapy
- Were unable to consent to and/or engage in therapy
- Had insufficient English or language abilities to support the person with dementia or engage in study/Change Interviews
- Were unable to consent to and/or engage in study
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 TherapyThere is no specific protocol for ACT with dementia, therefore a published ACT protocol, 'Better Living with Illness' (Brassington et al., 2016), will be used flexibly to guide the intervention. | Other | Acceptance and Commitment Therapy |
Primary outcome
Change in anxiety
Time frame: Through study completion, up to 24 weeks
Generalised anxiety disorder questionnaire (GAD-7), scored 0-21, where higher scores indicate a greater severity of anxiety.
Change in depression
Time frame: Through study completion, up to 24 weeks
Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.
4 secondary outcomes
Change in psychological flexibility
Time frame: Through study completion, up to 24 weeks
Change in wellbeing
Time frame: Through study completion, up to 24 weeks
Change in client problems
Time frame: Through study completion, up to 24 weeks
Change in therapeutic alliance
Time frame: Through study completion, up to 12 weeks
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 19 Aug 2022.
- Individual participant dataSharing planned: Yes. The study data was written up as part of the student Doctoral Thesis and will be submitted in partial fulfilment of the requirements for the Trent Doctorate in Clinical Psychology (DClinPsy) in February 2022. Participants chose a pseudonym for themselves to be used in publications (e.g. electronic documents, written notes and transcripts) to prevent identification and references to personal information (e.g. other people's names, locations) were altered.
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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.
Danielle De Boos, Dr study director
University of Nottingham
1 site 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 in people with Acceptance and Commitment Therapy and Dementia, run by University of Nottingham 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 9 inclusion and 7 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 19 Aug 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?
Change in anxiety (time frame: Through study completion, up to 24 weeks). The study lists 2 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 19 Aug 2022.