ACT for People With Dementia Experiencing Psychological Distress

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630912
• Other study ID #: 20064
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: July 22, 2022

Study information

• Verified date: August 2022
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 22, 2022
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Community Mental Health Team for Older People	Newark	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Nottinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in psychological flexibility	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
Secondary	Change in wellbeing	Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.	Through study completion, up to 24 weeks
Secondary	Change in client problems	Personal questionnaire (PQ), where higher scores indicate greater severity of problems.	Through study completion, up to 24 weeks
Secondary	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).	Through study completion, up to 12 weeks