- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04630912
ACT for People With Dementia Experiencing Psychological Distress
Acceptance and Commitment Therapy (ACT) for People With Dementia Experiencing Psychological Distress: a Hermeneutic Single Case Efficacy Design (HSCED) Series
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nottinghamshire
-
Newark, Nottinghamshire, United Kingdom
- Community Mental Health Team for Older People
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acceptance and Commitment Therapy
12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, up to 24 weeks
|
|
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.
|
Through study completion, up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in psychological flexibility
Time Frame: Through study completion, up to 24 weeks
|
Comprehensive assessment of Acceptance & Commitment Therapy (CompACT-SF), scored 0-48, where higher scores indicate increased psychological flexibility.
|
Through study completion, up to 24 weeks
|
|
Change in wellbeing
Time Frame: Through study completion, up to 24 weeks
|
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.
|
Through study completion, up to 24 weeks
|
|
Change in client problems
Time Frame: Through study completion, up to 24 weeks
|
Personal questionnaire (PQ), where higher scores indicate greater severity of problems.
|
Through study completion, up to 24 weeks
|
|
Change in therapeutic alliance
Time Frame: Through study completion, up to 12 weeks
|
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).
|
Through study completion, up to 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Danielle De Boos, Dr, University of Nottingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
IPD Sharing Supporting Information Type
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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