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

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ClinicalTrials.gov Identifier: NCT02454465
Recruitment Status : Unknown
Verified May 2015 by Ilan Ben-Zion, University of Hertfordshire.
Recruitment status was:  Not yet recruiting
First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Ilan Ben-Zion, University of Hertfordshire

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.


Condition or disease Intervention/treatment Phase
Brain Injuries Multiple Sclerosis Parkinson Disease Stroke Other: Acceptance and Commitment Therapy group Not Applicable

Detailed Description:

A variety of psychological approaches have been developed in order to support this population. One of the most popular approaches to working psychologically with this population is through the use of Cognitive Behavioural Therapy (CBT). However, research suggests that the use of CBT in this population has varying levels of effectiveness with some evidence of negative outcomes (Lincoln and Flannagan, 2003). Therefore, it would be worthwhile investigating other models of working with this population, such as Acceptance and Commitment Therapy (ACT). ACT which has been gaining popularity and is a growing area in supporting those with neurological conditions.

Contrary to widespread symptom reduction approaches such as CBT, the use of ACT is based on emotional acceptance and supporting individuals to live a valued life, despite ongoing symptoms. It appears under the umbrella of "third-wave" approaches and focuses on altering an individual's relationship with their thoughts and feelings, rather than focusing on altering the content of such experiences. In addition to this, ACT aims to support people to experience their internal processes in a non-judgemental and mindful manner, which enables them to participate in meaningful action. In order to do this, the ACT model focuses on six core concepts which each contribute to helping an individual to develop their Psychological Flexibility. Psychological Flexibility is defined by the ability to connect with the present moment and act according to one's set of values. In a move away from experiential avoidance (ie. avoiding ones thoughts and feelings), the ability to be flexible offers individuals the choice to commit to their values and change their actions or persist with those which are working for them.

It has been suggested that ACT may be particularly helpful for those adjusting to neurological conditions as it works to enable emotional acceptance and an integration of an individual's impairments into their new self-concept. This has been supported by research investigating the effectiveness of ACT in working with those with adjustment difficulties following traumatic and acquired brain injury. One such study investigated the use of ACT in the promotion of psychological adjustment following Traumatic Brain Injury. Findings indicated reduced psychological distress and increased Psychological Flexibility following the ACT intervention. One reason ACT is more desirable for this population is through the use of more experiential methods and less reliance on verbal expression, as verbal abilities can sometimes be compromised by a neurological condition. Rather than attempt to reduce symptomatology, techniques such as mindfulness encourage the individual to notice their difficulties and experience these with curiosity and openness. In addition to this, there is evidence that the use of acceptance based techniques support individuals to adapt their behaviour and reintegrate socially in a way that is meaningful to them. As a result, this may enable the individual to adjust to their new circumstances and enable them to reconnect with their values and commit to moving their life in a direction they value.

Overall, the use of ACT is a promising intervention for individuals adjusting following a diagnosis of a neurological disorder. However, with a limited number of studies investigating the topic, further research is required into the effectiveness of ACT within neuro-rehabilitation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Time to ACT": Multi-site Evaluation of an Acceptance and Commitment Therapy Group Intervention for Adjustment Difficulties in Neurological Conditions
Study Start Date : July 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention group
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
Six week, Acceptance and Commitment Therapy group for those with adjustment difficulties following an acquired/traumatic brain injury or other neurological condition.
No Intervention: Waiting list group
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.



Primary Outcome Measures :
  1. Change in Psychological Flexibility on the Acceptance and Action Questionnaire between baseline, 6 weeks and 10 weeks. [ Time Frame: Participants will be assessed at baseline, 6 weeks and 10-12 weeks. ]

Secondary Outcome Measures :
  1. Change in Low mood on the Patient Health Questionnaire -9 between baseline, 6 weeks and 10 weeks. [ Time Frame: Participants will be assessed at baseline, 6 weeks and 10-12 weeks. ]
  2. Anxiety on the Generalised Anxiety Disorder Questionnaire -7 between baseline, 6 weeks and 10 weeks. [ Time Frame: Participants will be assessed at baseline, 6 weeks and 10-12 weeks. ]
  3. Severity of individual difficulties on a Visual Analog Scale between baseline, 6 weeks and 10 weeks. [ Time Frame: Participants will be assessed at baseline, 6 weeks and 10-12 weeks. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454465


Contacts
Contact: Ilan Ben-Zion 01707 286322 i.ben-zion@herts.ac.uk

Sponsors and Collaborators
University of Hertfordshire
Investigators
Principal Investigator: Saskia Keville University of Hertfordshire

Responsible Party: Ilan Ben-Zion, Mr Ilan Ben-Zion, University of Hertfordshire
ClinicalTrials.gov Identifier: NCT02454465     History of Changes
Other Study ID Numbers: LMS/PG/NHS/00370
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Parkinson Disease
Multiple Sclerosis
Brain Injuries
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries