ACT for People With Dementia Experiencing Psychological Distress

• ClinicalTrials.gov Identifier: NCT04630912
• Recruitment Status: Active, not recruiting
• First Posted: November 16, 2020
• Last Update Posted: May 4, 2021
• Sponsor: University of Nottingham
• Collaborator: Nottinghamshire Healthcare NHS Trust
• Information provided by (Responsible Party): University of Nottingham

Study Description

Brief Summary:

Dementia is a condition that causes cognitive decline beyond normal ageing. Anxiety and depression are very common in people with dementia, but their needs are often under-recognised and under-served. Acceptance and Commitment Therapy (ACT) can reduce anxiety and depression by increasing psychological flexibility, the ability to pursue a meaningful life, in spite of unpleasant thoughts or feelings. There is much to learn about if and how ACT works for people with dementia, and whether it could be an effective psychological therapy for this population.

Three participants with a dementia diagnosis and clinically-significant levels of anxiety and/or depression will be identified by their GP or Memory Assessment Service (MAS) in Nottinghamshire. Participants will attend 12 weekly, 90-minute sessions of ACT with the Principal Investigator (PI), accompanied by their caregiver if they so wish. In session, participants will complete several short questionnaires to measure their anxiety and depression, goals for therapy, psychological flexibility and relationship with the therapist. One week after the final session, an independent researcher will meet with participants and their carers to discuss their opinions of therapy and any changes to their anxiety and/or depression. One and three months after therapy, participants will be sent two short questionnaires to measure their current anxiety and depression.

Information gathered from the independent researcher and questionnaires will be used to develop a case record for each participant, which will be looked at by independent psychotherapy experts to see whether ACT was effective.

This research is being funded by Health Education England and is expected to last one year in total. Participant duration will last about 7 months. The study will form a Doctoral Thesis at the University of Nottingham and will be submitted to a peer-reviewed journal for distribution.

Condition or disease	Intervention/treatment	Phase
Acceptance and Commitment Therapy; Dementia	Other: Acceptance and Commitment Therapy	Not Applicable

Detailed Description:

The study will involve a small case series of up to six participants (three people with dementia and up to three caregivers depending on the person with dementia's preference), meaning the PI will be able to track on an individual level. Individuals who express interest will be contacted by the student via telephone or email. The PI will provide information pertaining to all aspects of study participation prior to recruitment.

Procedure & Intervention Content,

Part 1:

As part of the practitioner-researcher model, the PI will be delivering the ACT intervention following the completion of ACT training and pre-adaptational work for use with people with dementia. Verbal information may be supported by visual aids and written information to support retention and reminders of any between-session tasks. Although there is no specific protocol for ACT with dementia, a published ACT protocol, 'Better Living with Illness' (Brassington et al., 2016), will be used flexibly to guide the intervention.

The HSCED will include baseline and intervention phases. As participants will be recruited to the study at different times, baseline lengths will vary. This may strengthen the design by reducing the possibility of any observed changes being attributed to time-based effects (after a duration of monitoring).

The intervention will be delivered on an individual basis for up to 90-minute, weekly sessions. There will be a standard number of up to 12, but this will be reviewed at session six. At the beginning of each therapy session, the PI will offer introductions, provide reminders about the purpose of the study, confidentiality and its limits and gain verbal consent to proceed. Reported changes will also be captured at the beginning of each session, for example, 'checking-in' with participants and inviting them to share any reflections on therapy or changes they have noticed between sessions.

ACT fidelity will be assessed by the PI using the ACT Fidelity Measure (O'Neill, Latchford, McCracken & Graham, 2019). The ACT-FM is a 25-item coding system that captures depth and frequency of coverage of major ACT components and non-adherent components through four main areas within ACT; Therapist Stance, Open Response Style, Aware Response Style and Engaged Response Style.

At baseline (first session), last session and at 1 and 3-month follow-ups, participants (people with dementia) will complete self-report measures of anxiety (with the GAD-7) and depression (with the PHQ-9). At each session and at 1 and 3 month follow-ups, they will also complete measures of wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale; SWEMWS), personal problems (Personal Questionnaire; PQ), psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes; CompACT-SF) and a measure of relational process (Session Rating Scale; SRS) to support their rich case record and provide data on the quality of the therapeutic alliance as a rival hypothesis for interventional change. It will be considered whether any of these measures could be completed by the PI from session recordings to try to reduce participant burden.

Part 2:

One week post-therapy, a semi-structured Change Interview will be conducted with participants and their caregivers together by an independent researcher to obtain their views about their experience of therapy, including change processes, consideration of what they attribute change to and what may have enabled or hindered change, if change occurred. These will likely take place at a room at one of the universities, location convenient for the participant or remotely via telephone or videocall. The interviews will be audio-recorded with a digital dictation device for later transcription by the student to contribute to the rich case record of each participant.

Practical Aspects:

Due to COVID-19, there will be two options for intervention delivery: (A) face-to-face as planned; or (B) remotely via telephone or videocall.

In Option A, the PI will offer flexibility regarding the location and time of the ACT intervention. It is understood that people with dementia are often marginalised, therefore the PI will make efforts to travel to them and make any reasonable adjustments. Participants may be telephoned to prompt or remind them of the therapy start time if necessary. Location options will include participants' homes, NHS site or University premises, depending on the preferences of the participant. All therapy sessions will be conducted in accordance with the University of Nottingham's (UoN) and respective NHS Trust's Lone Working Policies. The attendance of caregivers at therapy sessions will be negotiated with the participant. There is an acknowledgement of caregivers' likely role in transporting and accompanying participants to their appointments. All attendees (PI, participant and caregiver) will be required to wear Personal Protective Equipment (PPE) and adhere to social distancing measures in accordance with COVID-19 restrictions.

In Option B, the PI will negotiate an appropriate appointment time (between 9am-5pm on weekdays) to conduct the intervention. Again, the attendance of caregivers at therapy sessions will be negotiated with the participant. There is an acknowledgement that caregivers may prompt or support clients with between session tasks. Caregivers will also be invited to Change Interviews following the completion of therapy. The Change Interviews will involve asking participants about their experience of the therapy, what they found helpful and less helpful, any improvements that could be made and asking both participants and carers whether they have noted any changes in wellbeing or functional ability over the intervention period.

All therapy sessions will be audio-recorded with an encrypted, digital dictation device for storage and later transcription for quality and ACT fidelity checks. This will be clarified on the Participant Information Sheet and at the beginning of each therapy session. The PI will also take written notes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Hermeneutic 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: January 29, 2021
• Estimated Primary Completion Date: July 2021
• Estimated Study Completion Date: October 2021

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.

Outcome Measures

Primary Outcome Measures :

1. Change in anxiety [ Time Frame: 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.
2. Change in depression [ Time Frame: 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 :

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

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Inclusion criteria for people with dementia

Participants can be included in the study if they have:

• 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) because this likely resembles service criteria, identifies the target population and ensures the intervention has the best chance of evoking improvement.
• Aged 65+ (no maximum age limit).
• Ability to give informed consent

Inclusion criteria for caregiver of person with dementia

Participants can be included in the study if they:

• Care for someone with a clinical diagnosis of dementia (any type)
• Paid or unpaid who regularly supports them with activities of daily living
• Aged 18+ (no maximum age limit)
• Ability to give informed consent

Exclusion Criteria:

Exclusion criteria for people with dementia

Participants will be excluded if they:

• Are already receiving psychotherapy
• Have insufficient English or language abilities to engage in therapy
• Are unable to consent to and/or engage in therapy

Exclusion criteria for caregiver of person with dementia

Participants will be excluded if they:

• Have insufficient English or language abilities to support the person with dementia or engage in study/Change Interviews
• Are unable to consent to and/or engage in study

Contacts and Locations

Locations

United Kingdom

Community Mental Health Team for Older People

Newark, Nottinghamshire, United Kingdom

Sponsors and Collaborators

University of Nottingham

Nottinghamshire Healthcare NHS Trust

Investigators

• Study Director: Danielle De Boos, Dr; University of Nottingham

More Information

• Responsible Party: University of Nottingham
• ClinicalTrials.gov Identifier: NCT04630912
• Other Study ID Numbers: 20064
• First Posted: November 16, 2020
• Last Update Posted: May 4, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

The study data will be written up as part of the student Doctoral Thesis and will be submitted in partial fulfilment of the requirements for the Trent Doctorate in Clinical Psychology (DClinPsy) in February 2022.

Participants will be given opportunity to choose a pseudonym for themselves to be used in any publications (e.g. electronic documents, written notes and transcripts) to prevent identification and references to personal information (e.g. other people's names, locations) will be altered.

• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Nottingham:

Dementia; Anxiety; Depression; Psychological distress

Additional relevant MeSH terms:

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