ACT for People With Dementia Experiencing Psychological Distress

NCT04630912 | Completed

• 1 other identifier: 20064
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acceptance and Commitment Therapy; Dementia

Keywords

Dementia; Psychological distress; Psychological therapy; ACT; Acceptability; HSCED

Outcome Measures

Primary Outcomes (2)

• Change in anxiety

  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

  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 Outcomes (4)

• Change in psychological flexibility

  Through study completion, up to 24 weeks

• Change in wellbeing

  Through study completion, up to 24 weeks

• Change in client problems

  Through study completion, up to 24 weeks

• Change in therapeutic alliance

  Through study completion, up to 12 weeks

Study Arms (1)

Acceptance and Commitment Therapy

EXPERIMENTAL

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

Other: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy OTHER

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.

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)
• Were paid or unpaid and regularly supported them with activities of daily living
• Aged 18+ (no maximum age limit)
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Nottinghamshire Healthcare NHS Trust: collaborator

Study Sites (1)

Community Mental Health Team for Older People

Newark, Nottinghamshire, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Danielle De Boos, Dr

  University of Nottingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hermeneutic single case efficacy design (HSCED) series

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 16, 2020
• Study Start: January 20, 2021
• Primary Completion: October 14, 2021
• Study Completion: July 22, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: July 2022

Locations

GB (1)