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Clinical Trials/NCT04280445
NCT04280445CompletedNot Applicable

Acceptance and Commitment Therapy for Older Adults Experiencing Psychological Distress: A Hermeneutic Single Case Efficacy Design (HSCED) Series

University of Lincoln1 site in 1 country3 target enrollmentStarted: April 29, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3
Locations
1
Primary Endpoint
Change in Quality of Life Assessed Using the Older People's Quality of Life Questionnaire (OPQOL-brief).

Study Overview

Brief Summary

Title: Acceptance and Commitment Therapy for older adults experiencing psychological distress: A hermeneutic single case efficacy design (HSCED) series.

Anxiety and depression in older age is associated with increased level of disability and lower quality of life (OAs). Unfortunately, pharmacological treatments are disproportionality relied upon to manage the mental health of OAs. Despite cognitive behaviour therapy (CBT) being the recommended psychotherapy, there is evidence that CBT is less effective for OAs than younger populations.

An alternative treatment, Acceptance and Commitment Therapy (ACT), has been shown to be effective in reducing distress for OAs experiencing physical health difficulties. Several case studies have also indicated that ACT can be effective for OAs with psychological difficulties. ACT aims to change how a person interacts with their thoughts/feelings; to reduce avoidance; and to promote value-focused living.

The study aims to use an adjudicated HSCED to answer the following questions:

i) Is ACT an effective intervention for older adult clients experiencing psychological distress.

ii) Do meaningful changes occur for client-participants over the course of ACT intervention?

iii) What specific factors (ACT-specific, non-specific, extra-therapeutic) contribute to observed changes?

iv) Are observed changes broadly attributable to the ACT intervention?

v) What adaptations may facilitate change when using ACT with older adult clients.

For the study, up to four participants will be recruited from an OA community mental health team, each receiving up to 12 individual sessions of ACT. Participants will be required to complete a number of questionnaires throughout the study, including before/after sessions. Post-treatment, there will be a semi-structured 1:1 interview to explore any changes participants experienced, before a six-week follow-up is employed to check stability of change.

Detailed Description

This study aims to investigate whether Acceptance and Commitment Therapy (ACT) is an effective psychotherapeutic intervention for older adults experiencing psychological distress; what processes contribute towards psychological change; and what adaptations may be required to optimise ACT for older adults. There is currently an over-reliance on pharmacological treatments to manage older adult mental health (Andreescu & Reynolds, 2011), and a lack of inclusion of older adult in efficacy studies of psychological treatments (Gatz, 2006). Cognitive behaviour therapy (CBT) is the most evidence-based psychological treatment for mental health conditions. It emphasises the link between thoughts and feelings, and uses cognitive restructuring to facilitate improvement in psychological symptoms. However, of the studies that have included older adults, there is evidence that CBT has a lower effect size in older adults than with working age adults (Kishita & Laidlaw, 2017). There are a number of possible reasons for this, including a lack of age specific adaptations, the over focus on diagnosis specific treatment protocols in CBT, and the increasing physical and psychological co-morbidity associated ageing.

ACT is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl & Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012). We propose that ACT would be especially suitable for older adult clients due to the high rate of co-morbidity older adults experience and the reduced ability to change aspects of these.

However, there is a lack of understanding about the processes by which ACT works (Öst, 2014). Randomised controlled trails (RCTs) are the standard research methodology to investigate psychotherapy efficacy. Due to the stringent criteria required for RCT analyses, there is a limit to how transferrable the findings of an RCT can be to clinical populations (i.e. heterogenous groups). As such, a hermeneutic single case efficacy design (HSCED) is an ideal methodology to employ to identify what contributes towards change for each client. HSCED benefits from high ecological validity, whilst actively focusing on non-specific factors (components common to all psychotherapies, e.g., therapeutic alliance) and extra-therapeutic factors (components that are not related to the therapy, usually participant factors) to delineate change processes.

The research proposal has been developed as part of a Doctoral Thesis in Clinical Psychology. This involved various research presentations panels and submission of an initial research protocol. These are designed to guide the decision-making process and gain feedback from the course research team. As part of the doctoral program, each trainee is allocated a Primary and Secondary Research Supervisor (both Clinical Psychologists), who aided in shaping the practicalities of this research proposal. Each project also recruits a Field Supervisor who supports with expertise in the project area. Participants will be recruited from the service the Field Supervisor is employed at, thereby creating a direct level of clinical supervision that is paramount to psychotherapy.

Participants will be informed about the study through a member of their healthcare team. The service will ensure potential participants have the capacity to consent to treatment and will provide them with an overview of the study. Potential participants will be made aware of informed consent; that they do not have to take part and that declining to take part will in no way affect their treatment from the service. If a participant declines to take part at this stage, they will be offered treatment as usual from the service. If they consent to take part, the researcher will contact them the following week to answer any additional questions. This will allow them sufficient time to consider whether they would like to take part or not.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Be at least 65 years of age.
  • •Score at least 8 on the Hospital Anxiety and Depression Scale (HADS; ZIgmond & Snaith, 1983) on either the anxiety or depression sub-scale. The HADS is an outcome measure already used by the MHSOP.
  • •Be referred to the MHSOP for psychological support.
  • •Have capacity to give informed consent.
  • •Be willing to engage in one-to-one psychotherapy.
  • •Be able to travel to the service (either independently or with support).

Exclusion Criteria

  • •A score lower than 22-24 on the MoCA. This is to screen for a level of cognitive deficit, which cannot be accommodated for in the current study, due to the adaptations which will be required (e.g. review sessions, carer enrolment to support memory consolidation). Cut-off limit is dependent on the individual's age and education history. The MoCA is administered by the MHSOP as standard practice.
  • •Not rated higher than Cluster 8 (Mental Health Clustering Booklet 2013/14, Department of Health), a categorisation based on the Health of the Nation Outcome Scale (HoNOS; Wing et al., 1998). Clusters higher than 8 are associated with clients presenting with symptoms of psychosis and it is felt that this level of mental health problem would cause serious heterogeneity between client cases. As standard practice, the MHSOP at Ling Bar Hospital will have rated the client prior to consideration for the study.
  • •Inability to understand English to a level required to participate fully in the intervention. This is due to a lack of ability to benefit from the intervention without an interpreter, and the impact an interpreter would have on the non-therapeutic processes (e.g. alliance) being measured in this study.
  • •Not currently undertaking any other psychological therapy, talking therapy or counselling. This is due to the potential impact the other therapy could have on change and the inability to fully account for this.

Arms & Interventions

Psychological therapy

Experimental

All participants will receive psychological therapy. There will be no placebos or waiting list controlled participants to compare findings to.

Intervention: Psychological therapy (Other)

Outcomes

Primary Outcomes

Change in Quality of Life Assessed Using the Older People's Quality of Life Questionnaire (OPQOL-brief).

Time Frame: up to 20 weeks

Brief measure of quality of life (QoL) in older age.

Secondary Outcomes

  • Client's Level of Cognitive Functioning Assessed Using the Montreal Cognitive Assessment (MoCA).(up to 5 weeks)
  • Symptoms of Anxiety and Depression Assessed With the Hospital Anxiety and Depression Scale (HADS).(up to 20 weeks)
  • Change in/Progress on Client's Goals Assessed Using the Simplified Personal Questionnaire (PQ).(up to 20 weeks)
  • Change in Client's Weekly Level of Quality of Life Assessed Using the Outcome Rating Scale (ORS).(up to 20 weeks)
  • Change in Therapeutic Alliance Assessed With the Session Rating Scale (SRS).(up to 20 weeks)
  • Client's (Qualitative) Views on Individual Therapy Sessions Assessed With the Helpful Aspects of Therapy Form (HAT).(up to 20 weeks)
  • Change in Psychological Flexibility Assessed Using the CompACT(up to 20 weeks)
  • Client's Attribution of Change and View on Therapy Assessed With the Change Interview(up to 20 weeks)
  • Adherence to ACT Related Processes Assessed With the ACT Fidelity Measure (ACT-FM).(up to 20 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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