Clinical trial NCT04280445: Acceptance and Commitment Therapy for Older Adults
Official title: Acceptance and Commitment Therapy for Older Adults Experiencing Psychological Distress: A Hermeneutic Single Case Efficacy Design (HSCED) Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Anxiety
Depression
Keywords: Aging
Acceptance and Commitment Therapy
Psychological distress
Anxiety
Depression
Hermeneutics
Lead sponsor: University of Lincoln
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will employ an adjudicated Hermeneutic Single Case Efficacy Design (HSCED) series with three participants. Following Elliott's (2002; Elliott et al., 2009) approach, a crucial aspect of HSCED research is the formation of rich case records. Developed for each client, these consist of data from various time points in the study, and include demographic, quantitative (outcome measures, treatment fidelity measures etc.) and qualitative sources (Change Interview, therapy feedback, therapy process notes and recordings). The rich case records are then cross-referenced and synthesised into an affirmative and sceptic brief. These briefs are then presented to an expert panel to be adjudicated on the process of change. The resulting decisions will then allow for a between-participant analysis of what components contributed towards change and why.
Primary purpose: TREATMENT

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.

This research aims to use a sample that is representative of older adults presenting with psychological distress. See Inclusion/Exclusion sections for further explanation of these criteria.

This study aims to reflect usual clinical practice where possible; therefore, the burden to participants will be of a similar level to treatment as usual. That is, they will be expected to attend the older adults service for regular one-to-one psychotherapy and to discuss their mental health difficulties, contributing factors and what is maintaining their difficulties. Thus, as with any psychological therapy, there is a potential risk that talking about distressing experiences will cause an increase in frequency or intensity of pre-existing mental health conditions. These risks will be monitored through the study by the Trainee Clinical Psychologist (who is both researcher and therapist) through discussion with the participant, use of outcome measures and importantly by utilising weekly clinical supervision with the Clinical Psychologist at the service. This allows a space for any concerns to be raised and for the service to have clinical oversight of the participants.

The aspects of the study which are additional to usual practice are as follows: participants will be required to complete more questionnaires; and participants will be required to come in for an interview after the block of therapy has ended. Every effort has been made to reduce the burden these place upon participants. For instance, shorter questionnaires have been used where possible. Participants will also be asked about any adaptations required to complete questionnaires (e.g. larger font, someone completing questionnaires with them). Participants will be reimbursed for the aspects of the study which are additional to usual practice.

There are several potential benefits to participants taking part in this research, as suggested by the ACT literature. These include decreased psychological distress, increased psychological flexibility and improved quality of life.

To ensure confidentiality, Participant Study Numbers (PSN) will be assigned to each participant to correspond with treatment data. PSNs will be listed in the Trial Recruitment Log along with participant's name, date of birth and NHS number. All other documents related to the participant will use the PSN only. All researchers will endeavour to protect the rights of the participants to privacy and will adhere to the Data Protection Act, 2018. Only the minimum required information for the purposes of the study will be collected. Participant information will be held securely, in a locked room, or locked cupboard or cabinet. Access to the information will be limited to the study staff and investigators. Computer held data including the study database will be held securely and password protected. All data will be stored on a secure dedicated web server. Access will be restricted by user identifiers and passwords (encrypted using a one-way encryption method). Information about the study in the participant's medical records / hospital notes will be treated confidentially in the same way as all other confidential medical information.

As the main researcher is also the therapist, potential conflict of interests will be managed by: using weekly clinical supervision; fortnightly ACT supervision; a 20% random sampling of the audio recorded sessions to ensure adherence to ACT techniques; and using an independent researcher to carry out the Change Interview. Another benefit of using a HSCED series, is that an independent panel adjudicates on the final outcome as to where change was attributed for each client, reducing the researcher-therapist bias.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Life Assessed Using the Older People's Quality of Life Questionnaire (OPQOL-brief).
timeFrame: up to 20 weeks
Secondary outcomes:
measure: Client's Level of Cognitive Functioning Assessed Using the Montreal Cognitive Assessment (MoCA).
timeFrame: up to 5 weeks
measure: Symptoms of Anxiety and Depression Assessed With the Hospital Anxiety and Depression Scale (HADS).
timeFrame: up to 20 weeks
measure: Change in/Progress on Client's Goals Assessed Using the Simplified Personal Questionnaire (PQ).
timeFrame: up to 20 weeks
measure: Change in Client's Weekly Level of Quality of Life Assessed Using the Outcome Rating Scale (ORS).
timeFrame: up to 20 weeks
measure: Change in Therapeutic Alliance Assessed With the Session Rating Scale (SRS).
timeFrame: up to 20 weeks
measure: Client's (Qualitative) Views on Individual Therapy Sessions Assessed With the Helpful Aspects of Therapy Form (HAT).
timeFrame: up to 20 weeks
measure: Change in Psychological Flexibility Assessed Using the CompACT
timeFrame: up to 20 weeks
measure: Client's Attribution of Change and View on Therapy Assessed With the Change Interview
timeFrame: up to 20 weeks
measure: Adherence to ACT Related Processes Assessed With the ACT Fidelity Measure (ACT-FM).
timeFrame: up to 20 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Mental Health Services for Older People
state: Nottinghamshire
Study officials:
affiliation: University of Lincoln
name: Nima Golijani-Moghaddam, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott R. Hermeneutic single-case efficacy design. Psychother Res. 2002 Mar 1;12(1):1-21. doi: 10.1080/713869614.
citation: Hayes SC. Acceptance and commitment therapy: towards a unified model of behavior change. World Psychiatry. 2019 Jun;18(2):226-227. doi: 10.1002/wps.20626. No abstract available.
citation: Ost LG. The efficacy of Acceptance and Commitment Therapy: an updated systematic review and meta-analysis. Behav Res Ther. 2014 Oct;61:105-21. doi: 10.1016/j.brat.2014.07.018. Epub 2014 Aug 19.
citation: A-Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30-6. doi: 10.1159/000365764. Epub 2014 Dec 24.
citation: Petkus AJ, M A, Wetherell JL. Acceptance and Commitment Therapy with Older Adults: Rationale and Considerations. Cogn Behav Pract. 2013 Feb;20(1):47-56. doi: 10.1016/j.cbpra.2011.07.004.