NCT04280445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 29, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 2, 2021

Completed
Last Updated

January 1, 2025

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

February 19, 2020

Results QC Date

October 4, 2021

Last Update Submit

December 10, 2024

Conditions

Keywords

AgingAcceptance and Commitment TherapyPsychological distressAnxietyDepressionHermeneutics

Outcome Measures

Primary Outcomes (1)

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

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

    up to 20 weeks

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Psychological therapy

EXPERIMENTAL

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

Other: Psychological therapy

Interventions

Acceptance and Commitment Therapy (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).

Also known as: Acceptance and Commitment Therapy
Psychological therapy

Eligibility Criteria

Age65 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details65 years or older
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Services for Older People

Nottingham, Nottinghamshire, United Kingdom

Location

Related Publications (5)

  • Elliott R. Hermeneutic single-case efficacy design. Psychother Res. 2002 Mar 1;12(1):1-21. doi: 10.1080/713869614.

    PMID: 22471329BACKGROUND
  • 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.

    PMID: 31059616BACKGROUND
  • 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.

    PMID: 25193001BACKGROUND
  • 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.

    PMID: 25547522BACKGROUND
  • 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.

    PMID: 26997859BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr Daniell De Boos
Organization
Trent Doctorate in Clinical Psychology Programme, University of Nottingham, UK

Study Officials

  • Nima Golijani-Moghaddam, Dr

    University of Lincoln

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

April 29, 2020

Primary Completion

November 18, 2020

Study Completion

December 18, 2020

Last Updated

January 1, 2025

Results First Posted

November 2, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Results will be written up in a peer-reviewed journal and as part of a Doctoral Thesis. Individual participant data will be anonymised. Should a request be made for individualised data, this would have to be approved by the various ethical and research boards involved.

Locations