Brain InjuriesNCT02454465
Evaluation of an Acceptance and Commitment Therapy Group for Adjustment Difficulties in Neurological Conditions
A study testing Acceptance and Commitment Therapy group in people with Brain Injuries and Multiple Sclerosis, run by University of Hertfordshire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Brain Injuries, Multiple Sclerosis, Parkinson Disease
- What is being tested?
- Acceptance and Commitment Therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current drug or alcohol abuse
- Significant cognitive impairment
- Unable to consent to trial due to cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Time to ACT": Multi-site Evaluation of an Acceptance and Commitment Therapy Group Intervention for Adjustment Difficulties in Neurological Conditions
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.
Read more
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.
Read the 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.
- Conditions
- Brain Injuries, Multiple Sclerosis, Parkinson Disease, Stroke
- Being tested
- Acceptance and Commitment Therapy group
- Medical subject headings
- Brain Injuries, Multiple Sclerosis, Parkinson Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy groupOther
Six week, Acceptance and Commitment Therapy group for those with adjustment difficulties following an acquired/traumatic brain injury or other neurological condition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Flexibility on the Acceptance and Action Questionnaire between baseline, 6 weeks and 10 weeks.
Periodic assessment
Measured: 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.
Periodic assessment
Measured: 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.
Periodic assessment
Measured: 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.
Periodic assessment
Measured: Participants will be assessed at baseline, 6 weeks and 10-12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hertfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saskia Keville, Principal investigator, University of Hertfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454465
- Sponsor's protocol ID
- LMS/PG/NHS/00370
- Status last verified
- Sep 2021
- First submitted
- 19 May 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Time to ACT": Multi-site Evaluation of an Acceptance and Commitment Therapy Group Intervention for Adjustment Difficulties in Neurological Conditions
- ClinicalTrials.gov ID
- NCT02454465
- Acronym / sponsor ID
- LMS/PG/NHS/00370
- Conditions
- Brain Injuries, Multiple Sclerosis, Parkinson Disease, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Acceptance and Commitment Therapy groupThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Current drug or alcohol abuse
- Significant cognitive impairment
- Unable to consent to trial due to cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy groupSix week, Acceptance and Commitment Therapy group for those with adjustment difficulties following an acquired/traumatic brain injury or other neurological condition. | Other | Intervention group |
Primary outcome
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.
Periodic assessment
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saskia Keville principal investigator
University of Hertfordshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy group in people with Brain Injuries and Multiple Sclerosis, run by University of Hertfordshire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.