A Mixed-methods Evaluation of an Adapted Acceptance and Commitment Therapy (ACT) Group for Stroke Survivors

NCT03295032 | Completed

• 1 other identifier: Cardiff University
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

Brief Summary

Stroke is one of the main causes of acquired adult disability in the UK. Many psychological problems can also occur post-stroke; this has a marked impact on health service usage. As such, there is an outstanding need to increase and improve psychological resources within stroke services. The investigators proposed to adapt and evaluate the effectiveness of an acceptance and commitment therapy (ACT) group intervention for adult stroke survivors and their carers. The group will endeavour to promote positive adjustment and reduce levels of depression and anxiety. This study will have two parts.

Conditions

Stroke; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• Measuring a change in PHQ9 scores

  measure of depression

  baseline, 4 weeks and two month follow-up

Secondary Outcomes (4)

• Measuring a change in GAD7 scores

  baseline, 4 weeks and two month follow-up

• Measuring a change in Warwick and Edinburgh Mental Wellbeing Scale (WEMWBS) scores

  baseline, 4 weeks and two month follow-up

• Measuring a change in Adult Hope Scale (AHS) scores

  baseline, 4 weeks and two month follow-up

• Measuring a change in EQ-5D-5L scores

  baseline, 4 weeks and two month follow-up

Study Arms (2)

group-based ACT

EXPERIMENTAL

Stroke survivors were randomised into group-based ACT intervention consisting of 2hr sessions for four consecutive weeks.

Behavioral: Acceptance and Commitment Therapy (ACT)

Waiting list control

NO INTERVENTION

Waiting list control - received treatment as usual.

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

ACT is a psychological intervention; in this study it is being delivered as a 4-week psycho-educational group to stroke survivors and carers. Rather than attempting to control or ameliorate pain and suffering, ACT advocates that individuals remain open to internal private experiences (both positive and negative) and should focus on committing to a life which is congruent with their core values. Individuals learn to modify their relationship with these experiences, rather than change the experiences per se through processes such as mindfulness, acceptance and attention to values. This fundamental premise of ACT helps cultivate psychological flexibility.

group-based ACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must be \>18 years
• Clinical diagnosis of stroke (or carers of someone who has experienced a stroke)
• Must be able to understand English and communicate responses.
• The target volunteer has been referred to this stroke-adapted ACT course by a clinician.

You may not qualify if:

• Patients with any other acquired brain injury e.g. traumatic brain injury, encephalitis, tumours etc.
• Patients diagnosed with a degenerative condition e.g. dementias.
• Significant cognitive/language impairment that would prevent them from engaging with the group.
• Those experiencing severe psychotic symptoms
• Those who are receiving other therapies, as part of a multicomponent intervention which would prevent any changes specific to group psychotherapy to be estimated (with the exception of drugs for anxiety and depression).

Sponsors & Collaborators

• Cardiff University: lead
• Cwm Taf University Health Board (NHS): collaborator
• Cardiff and Vale University Health Board: collaborator
• Aneurin Bevan University Health Board: collaborator
• North Bristol NHS Trust: collaborator
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator
• BASF: collaborator

Study Sites (4)

Bristol Area Stroke Foundation

Bristol, England, BS13 9JN, United Kingdom

Location

Cardiff & Vale NHS Trust

Cardiff, Wales, CF62 2XX, United Kingdom

Location

Cwm Taf NHS Trust

Merthyr Tydfil, Wales, CF40 2LU, United Kingdom

Location

Aneurin Bevan NHS Trust

Newport, Wales, NP20 4SZ, United Kingdom

Location

Related Publications (5)

• Campbell Burton CA, Murray J, Holmes J, Astin F, Greenwood D, Knapp P. Frequency of anxiety after stroke: a systematic review and meta-analysis of observational studies. Int J Stroke. 2013 Oct;8(7):545-59. doi: 10.1111/j.1747-4949.2012.00906.x. Epub 2012 Sep 27.

  PMID: 23013268 BACKGROUND

• Constructing Grounded Theory: A practical guide through qualitative analysis Kathy Charmaz Constructing Grounded Theory: A practical guide through qualitative analysis Sage 224 pound19.99 0761973532 0761973532 [Formula: see text]. Nurse Res. 2006 Jul 1;13(4):84. doi: 10.7748/nr.13.4.84.s4.

  PMID: 27702218 BACKGROUND

• Feros DL, Lane L, Ciarrochi J, Blackledge JT. Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psychooncology. 2013 Feb;22(2):459-64. doi: 10.1002/pon.2083. Epub 2011 Oct 6.

  PMID: 23382134 BACKGROUND

• Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

  PMID: 16300724 BACKGROUND

• Kangas M, McDonald S. Is it time to act? The potential of acceptance and commitment therapy for psychological problems following acquired brain injury. Neuropsychol Rehabil. 2011 Apr;21(2):250-76. doi: 10.1080/09602011.2010.540920. Epub 2011 Jan 17.

  PMID: 21246445 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Professor Reg Morris, PhD

  Cardiff University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Part 1: Randomised Controlled Trial with an intervention (ACT group) and Waiting List Control arm. Part 2: Interviews

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 27, 2017
• Study Start: March 1, 2016
• Primary Completion: December 29, 2016
• Study Completion: December 29, 2016
• Last Updated: September 27, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)