ACT for People With Dementia Experiencing Psychological Distress

August 16, 2022 updated by: University of Nottingham

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nottinghamshire
      • Newark, Nottinghamshire, United Kingdom
        • Community Mental Health Team for Older People

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Danielle De Boos, Dr, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

October 14, 2021

Study Completion (Actual)

July 22, 2022

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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

July 2022

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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