Evaluation of an Acceptance and Commitment Therapy Group for Adjustment Difficulties in Neurological Conditions

NCT02454465 | Completed

• 1 other identifier: LMS/PG/NHS/00370
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

With an increase of over 38% in neurological related hospital admissions between 2008-13, there are now over 12.5 million cases of individuals with neurological conditions in the UK. Following diagnosis of a neurological condition, there is often a period of adjustment to new life circumstances, with changes to relationships, ability to work and leisure activities. With a future often fraught with uncertainty, psychological difficulties such as Anxiety and Depression are common. It is estimated that following diagnosis of a neurological condition, up to 60% of individual's will experience mental health difficulties. Acceptance and Commitment Therapy (ACT) has been gaining popularity in supporting those with neurological conditions. ACT is based on emotional acceptance and supporting individuals to live a valued life, despite ongoing symptoms. Research into the use of ACT with this population has found it to be effective in reducing levels of psychological distress and increasing psychological flexibility. With limited resources and an ever increasing desire to improve interventions offered to patients, services are now looking at new and innovative ways of offering increasingly effective and satisfactory treatments. Therefore, in early 2014, the author devised a six week ACT group intervention for adjustment following diagnosis of a neurological condition. The intervention provides a combination of ACT techniques, in addition to a space for group members to build relationships and share their difficulties, to help individuals increase acceptance of their difficulties and reduce psychological distress. Following an initial pilot, findings illustrated that participants' psychological distress reduced and psychological flexibility increased. Therefore, this research project aims to further evaluate the intervention under controlled conditions.

Conditions

Brain Injuries; Multiple Sclerosis; Parkinson Disease; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Psychological Flexibility on the Acceptance and Action Questionnaire between baseline, 6 weeks and 10 weeks.

  Periodic assessment

  Participants will be assessed at baseline, 6 weeks and 10-12 weeks.

Secondary Outcomes (3)

• Change in Low mood on the Patient Health Questionnaire -9 between baseline, 6 weeks and 10 weeks.

  Participants will be assessed at baseline, 6 weeks and 10-12 weeks.

• Anxiety on the Generalised Anxiety Disorder Questionnaire -7 between baseline, 6 weeks and 10 weeks.

  Participants will be assessed at baseline, 6 weeks and 10-12 weeks.

• Severity of individual difficulties on a Visual Analog Scale between baseline, 6 weeks and 10 weeks.

  Participants will be assessed at baseline, 6 weeks and 10-12 weeks.

Study Arms (2)

Intervention group

EXPERIMENTAL

The first group at the top of the waiting list will receive the Acceptance and Commitment Therapy group intervention, which is 1 hour per week for six weeks.

Other: Acceptance and Commitment Therapy group

Waiting list group

NO INTERVENTION

The outcomes of those on the waiting list will be compared with those in the intervention group. Once the intervention group completes, those on the waiting list will be invited to attend the Acceptance and Commitment Therapy group intervention.

Interventions

Acceptance and Commitment Therapy group OTHER

Six week, Acceptance and Commitment Therapy group for those with adjustment difficulties following an acquired/traumatic brain injury or other neurological condition.

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have been diagnosed with a neurological condition
• Experiencing difficulties with adjustment as identified through assessment with Psychology team
• Adult aged 18 and above
• Sufficient cognitive capacity and English language skills to participate in group discussions and complete written tasks

You may not qualify if:

• Current drug or alcohol abuse
• Significant cognitive impairment
• Unable to consent to trial due to cognitive impairment

Sponsors & Collaborators

• University of Hertfordshire: lead

Study Sites (1)

Jacketts Field

Abbots Langley, WD50PA, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries; Multiple Sclerosis; Parkinson Disease; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Saskia Keville

  University of Hertfordshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 27, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

GB (1)