ACT for People With Dementia Experiencing Psychological Distress
Primary Purpose
Acceptance and Commitment Therapy, Dementia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acceptance and Commitment Therapy focused on measuring Dementia, Psychological distress, Psychological therapy, ACT, Acceptability, HSCED
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for people with dementia
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
Inclusion criteria for caregiver of person with dementia
Participants were included in the study if they:
- Cared for someone with a clinical diagnosis of dementia (any type)
- Were paid or unpaid and regularly supported them with activities of daily living
- Aged 18+ (no maximum age limit)
- Able to give informed consent
Exclusion Criteria:
Exclusion criteria for people with dementia
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
Exclusion criteria for caregiver of person with dementia
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
Sites / Locations
- Community Mental Health Team for Older People
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acceptance and Commitment Therapy
Arm Description
12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6)
Outcomes
Primary Outcome Measures
Change in anxiety
Generalised anxiety disorder questionnaire (GAD-7), scored 0-21, where higher scores indicate a greater severity of anxiety.
Change in depression
Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.
Secondary Outcome Measures
Change in psychological flexibility
Comprehensive assessment of Acceptance & Commitment Therapy (CompACT-SF), scored 0-48, where higher scores indicate increased psychological flexibility.
Change in wellbeing
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.
Change in client problems
Personal questionnaire (PQ), where higher scores indicate greater severity of problems.
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).
Full Information
NCT ID
NCT04630912
First Posted
November 2, 2020
Last Updated
August 16, 2022
Sponsor
University of Nottingham
Collaborators
Nottinghamshire Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04630912
Brief Title
ACT for People With Dementia Experiencing Psychological Distress
Official Title
Acceptance and Commitment Therapy (ACT) for People With Dementia Experiencing Psychological Distress: a Hermeneutic Single Case Efficacy Design (HSCED) Series
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
July 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Nottinghamshire Healthcare NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acceptance and Commitment Therapy, Dementia
Keywords
Dementia, Psychological distress, Psychological therapy, ACT, Acceptability, HSCED
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Hermeneutic single case efficacy design (HSCED) series
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6)
Intervention Type
Other
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety
Description
Generalised anxiety disorder questionnaire (GAD-7), scored 0-21, where higher scores indicate a greater severity of anxiety.
Time Frame
Through study completion, up to 24 weeks
Title
Change in depression
Description
Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.
Time Frame
Through study completion, up to 24 weeks
Secondary Outcome Measure Information:
Title
Change in psychological flexibility
Description
Comprehensive assessment of Acceptance & Commitment Therapy (CompACT-SF), scored 0-48, where higher scores indicate increased psychological flexibility.
Time Frame
Through study completion, up to 24 weeks
Title
Change in wellbeing
Description
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.
Time Frame
Through study completion, up to 24 weeks
Title
Change in client problems
Description
Personal questionnaire (PQ), where higher scores indicate greater severity of problems.
Time Frame
Through study completion, up to 24 weeks
Title
Change in therapeutic alliance
Description
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).
Time Frame
Through study completion, up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for people with dementia
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
Inclusion criteria for caregiver of person with dementia
Participants were included in the study if they:
Cared for someone with a clinical diagnosis of dementia (any type)
Were paid or unpaid and regularly supported them with activities of daily living
Aged 18+ (no maximum age limit)
Able to give informed consent
Exclusion Criteria:
Exclusion criteria for people with dementia
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
Exclusion criteria for caregiver of person with dementia
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle De Boos, Dr
Organizational Affiliation
University of Nottingham
Official's Role
Study Director
Facility Information:
Facility Name
Community Mental Health Team for Older People
City
Newark
State/Province
Nottinghamshire
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
July 2022
Learn more about this trial
ACT for People With Dementia Experiencing Psychological Distress
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