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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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