ACT for People With Dementia Experiencing Psychological Distress

Sponsor

University of Nottingham (Other)

Overall Status

Completed

CT.gov ID

NCT04630912

Collaborator

Nottinghamshire Healthcare NHS Trust (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acceptance and Commitment Therapy Dementia	Other: Acceptance and Commitment Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Hermeneutic single case efficacy design (HSCED) seriesHermeneutic single case efficacy design (HSCED) series

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Acceptance and Commitment Therapy (ACT) for People With Dementia Experiencing Psychological Distress: a Hermeneutic Single Case Efficacy Design (HSCED) Series

Actual Study Start Date :

Jan 20, 2021

Actual Primary Completion Date :

Oct 14, 2021

Actual Study Completion Date :

Jul 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acceptance and Commitment Therapy 12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6)	Other: Acceptance and Commitment Therapy 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.

Arm

Intervention/Treatment

Experimental: Acceptance and Commitment Therapy

12 weekly, 90 minute ACT sessions with person with dementia (with a review at week 6)

Other: Acceptance and Commitment Therapy

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.

Outcome Measures

Primary Outcome Measures

Change in anxiety [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 [Through study completion, up to 24 weeks]
Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.

Secondary Outcome Measures

Change in psychological flexibility [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.
Change in wellbeing [Through study completion, up to 24 weeks]
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.
Change in client problems [Through study completion, up to 24 weeks]
Personal questionnaire (PQ), where higher scores indicate greater severity of problems.
Change in therapeutic alliance [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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