Evaluation of an Adapted ACT Group for Stroke & Brain Injury Survivors

NCT04995705 | Terminated

• 1 other identifier: 259095
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke and Acquired Brain Injury (ABI) represent a major cause of long-term disability among survivors. Many psychological difficulties can also occur including: depression, anxiety, fatigue, and post-traumatic stress disorder. This has a marked impact on health service usage. Despite certain interventions being offered to support stroke survivors and individuals with brain injury, there is still an outstanding need to increase and improve psychological resources for this population. This research proposes to evaluate the effectiveness of a group therapy intervention, using a model called Acceptance and Commitment Therapy (ACT), for stroke survivors and adults with ABI. This ACT group aims to promote positive adjustment and improve wellbeing, whilst also aiming to reduce levels of distress. The research will comprise of two parts (one quantitative and the other qualitative).

Conditions

Stroke; Acquired Brain Injury; Acceptance and Commitment Therapy; Brain Injuries

Keywords

Acceptance and Commitment Therapy; Adjustment

Outcome Measures

Primary Outcomes (4)

• Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)

  Exploring change in this measure of psychological flexibility

  Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)

• Dispositional or Adult Hope Scale

  Exploring change in this scale which assesses a person's global level of dispositional or trait hope.

  Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)

• Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)

  Exploring change CORE-OM, which measures levels of global distress

  Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)

• Euro-Qol: EQ-5D-5L

  Exploring change in this scale which measures health-related quality of life.

  Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)

Study Arms (2)

Experimental Group Based ACT

EXPERIMENTAL

Stroke survivors and individuals with brain injury were randomised into an adapted acceptance and commitment therapy (ACT) group-based intervention. This consisted of 2.5 hour sessions over 5 consecutive weeks.

Behavioral: Acceptance and Commitment Therapy (ACT)

Waitlist Control Group -

ACTIVE COMPARATOR

Stroke survivors and individuals with brain injury were randomised into an adapted acceptance and commitment therapy (ACT) group-based intervention. Participants within the waitlist control arm of the study had to wait six weeks before they were offered the same intervention as the intervention arm. They received treatment as usual.

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

ACT is a psychological intervention. ACT encourages individuals to remain open to internal experiences (positive, negative and neutral), rather than attempting to control or ameliorate them (which may only serve to increase pain and suffering). It also encourages individuals to focus on committing to a life that is congruent with their core values, regardless of the experiences that show up for them. The premise of this model is to learn to modify the relationship one has with their internal experiences (thoughts, feelings, physical sensations etc.), rather than change the experiences per se. This is achieved through different processes including mindfulness, acceptance, defusion and exploration of values. These core tenets of ACT help to cultivate psychological flexibility. This ACT intervention is delivered as a 5-week group for stroke survivors and adults with brain injury. It comprises of experiential and didactic components.

Experimental Group Based ACT; Waitlist Control Group -

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 of age or older.
• Participants must have a clinical diagnosis of stroke or brain injury
• Must be able to understand English and communicate responses
• The target participant has been referred to the adapted ACT group by a clinician, stroke association co-ordinator or senior Headway professional.
• Participants with a mild to moderate level of psychological need
• Participants must be capable of giving informed consent

You may not qualify if:

• Candidates with significant cognitive/language/behavioural impairment that would prevent them from engaging with the group
• Candidates with a diagnosed degenerative condition (e.g. dementia). (NB candidates with a brain tumour diagnosis who are currently stable will be eligible.)
• Candidates experiencing severe/active psychotic symptoms
• Candidates with a high level of psychological need that would be better met through a more intensive intervention
• Candidates receiving other therapies, as part of a multi-component intervention that would prevent any changes specific to the group psychotherapy to be estimated (except drugs for depression and anxiety)

Sponsors & Collaborators

• Anna Pennington: lead
• Stroke Implementation Group: collaborator
• Aneurin Bevan University Health Board: collaborator
• Swansea Bay University Health Board: collaborator

Study Sites (1)

Aneurin Bevan University Health Board

Newport, Wales, NP20 4SZ, United Kingdom

Location

Related Publications (8)

• Fleminger S, Ponsford J. Long term outcome after traumatic brain injury. BMJ. 2005 Dec 17;331(7530):1419-20. doi: 10.1136/bmj.331.7530.1419. No abstract available.

  PMID: 16356951 BACKGROUND

• Lincoln, N. B., Kneebone, I. I., Macniven, J. A., & Morris, R. C. (2012). Psychological management of stroke. John Wiley & Sons.

  BACKGROUND

• Graves JM, Rivara FP, Vavilala MS. Health Care Costs 1 Year After Pediatric Traumatic Brain Injury. Am J Public Health. 2015 Oct;105(10):e35-41. doi: 10.2105/AJPH.2015.302744. Epub 2015 Aug 13.

  PMID: 26270293 BACKGROUND

• Naylor, C., Parsonage, M., McDaid, D., Knapp, M., Fossey, M. & Galea, A. (2012). Long-term conditions and mental health: the cost of co-morbidities. The King's Fund, London, UK.

  BACKGROUND

• Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145. https://doi.org/10.1016/j.jcbs.2016.05.003

  BACKGROUND

• Evans, C., Mellor-Clark, J., Margison, F., Barkham, M., Audin, K., Connell, J., & McGrath, G. (2000). CORE: Clinical Outcomes in Routine Evaluation. Journal of Mental Health, 9(3), 247-255

  BACKGROUND

• Snyder CR, Harris C, Anderson JR, Holleran SA, Irving LM, Sigmon ST, Yoshinobu L, Gibb J, Langelle C, Harney P. The will and the ways: development and validation of an individual-differences measure of hope. J Pers Soc Psychol. 1991 Apr;60(4):570-85. doi: 10.1037//0022-3514.60.4.570.

  PMID: 2037968 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rebecca Large, Dr

  ABUHB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trials Manager

Model Details: Randomised waitlist control model.

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: April 8, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 23, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)