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
NCT number | NCT04630912 |
Other study ID # | 20064 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 20, 2021 |
Est. completion date | July 22, 2022 |
Verified date | August 2022 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Community Mental Health Team for Older People | Newark | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Nottinghamshire Healthcare NHS Trust |
United Kingdom,
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 |
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