Huntington DiseaseNCT02464293
A Pilot Evaluation of Mindfulness-based Cognitive Therapy for People With Huntington's Disease
A study testing Mindfulness-based cognitive therapy in people with Huntington Disease, run by Lancaster University at 1 site in United Kingdom.
Trial summary
This is a pilot study to see whether mindfulness-based cognitive therapy, which is a type of psychological therapy, is able to improve the psychological wellbeing of people who have the gene for Huntington's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Mindfulness-based cognitive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to 31 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For those with HD:
- Patient at Manchester Centre for Genomic Medicine (UK)
- All participants will have had genetic testing and shown to have the requisite CAG expansion on the huntingtin gene.
- Participants must be pre-symptomatic or at stage 1 (still able to function at home and at work and handle financial affairs)
- Clinical sign of depression (score on HADS of 7 or above)
- No significant medication changes in 6 weeks prior to starting the course
- For those who are relatives or friends of those with HD:
- Must be a relative or friend of someone participating in the MBCT course
Who cannot join
- Active suicidal intent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust
Manchester
About this study
This is a pilot study to see whether mindfulness-based cognitive therapy, which is a type of psychological therapy, is able to improve the psychological wellbeing of people who have the gene for Huntington's disease.
Read the detailed description
Huntingdon's disease (HD) is a genetic neurodegenerative condition which causes problems with movement, coordination and cognitive functioning, and emotional difficulties are also commonly experienced. It is believed to affect around five to ten in 100,000 people of European descent, with recent UK estimates as high as 11.2-13.5. Each child of an affected person has a 50% chance of inheriting the condition. As age of diagnosis is typically around 35-55, with time from diagnosis to death around 20 years, those who are diagnosed have often seen their parents affected by the condition.
Many people at various stages of HD (including those who carry the gene but are pre-symptomatic) experience low mood, anxiety and other psychological difficulties. Indeed, alongside functional capacity, mood may be one of the main factors which contributes to health related quality of life, more so than discrete motor problems, or cognitive impairment. In addition, reports from patients suggest emotional and social concerns are important for individuals with the condition at the pre-symptomatic stage, and these concerns remain throughout the disease course. Medication may be effective to alleviate psychological difficulties for some people, but its efficacy has not been conclusively proven and it is not suitable for all. Psychological interventions may provide an alternative or additional way of alleviating distress.
Although it is commonly presumed that biological factors are the main determinants of psychological distress in people with HD, several studies have indicated that, while these may indeed be important, psychological factors are also significant. For example beliefs about the disease and coping mechanisms are associated with poorer mental health and higher levels of depression. Such psychological beliefs and coping patterns can be adaptively changed using psychological interventions, for example cognitive-based psychological therapies.
Little progress has been reported on the development of psychological interventions in HD despite the fact that people with HD have expressed an interest in psychological approaches and these are currently being successfully developed for people with other neurological conditions (e.g., in people with Parkinson's disease). It is therefore proposed to pilot mindfulness-based cognitive therapy (MBCT) which, although originally developed to help people with remitted depression from relapse, has been increasingly used to help people with current difficulties. It has also been piloted with people with Parkinson's disease who found it an acceptable intervention and reported improvements in self-management and psychological wellbeing. In general, MBCT has also recorded other gains including improved sleep quality and social functioning. It has also received sufficient evidence for it to be a recommended approach in the UK NICE guidelines for people with a history of depression. MBCT can also reduce anxiety and provides group support. There are also indications that mindfulness training can improve neurocognitive functioning, even in people with neurodegenerative disease. Finally, a psychological therapy subgroup within the European Huntington's Disease Network has recently been formed, thus indicating the rise of interest in psychological approaches and the timely nature of this work.
Hence this study will provide the first indication of whether MBCT, a therapeutic approach with an established evidence base, would be acceptable and useful for people with HD. In order to meet this aim, MBCT will be delivered to two groups, one to individuals who carry the gene but are pre-symptomatic and one to individuals who have begun to experience symptoms but are at an early stage of the disease course.
Approaches to outcome evaluation should be incremental, with lower cost studies, e.g., qualitative investigations and case studies, being conducted before investment in randomised controlled trials is considered. Thus this study will follow this guidance by collecting both qualitative and quantitative data. The qualitative data will be analysed using interpretative phenomenological analysis, a methodology previously used in other qualitative studies on MBCT. Semi-structured interviews will provide data on the acceptability of the intervention and detailed accounts of participants' experience after the intervention has been provided. This will inform whether the MBCT intervention needs to be changed or adapted in further trials. The quantitative data will be used to provide basic pre and post intervention comparisons on a number of outcome variables relevant to MBCT, with the hypothesis that performance on these measures will improve post training. These data will also be used to estimate effect sizes for further trials so that these are suitably powered.
Given the considerable physical, cognitive and emotional consequences of the disease, HD not only affects the person with HD, but also those with whom they live, even in the pre-clinical phase. Family members often become caregivers and can have a reduced quality of life as a result, including experiencing low mood themselves. In fact, caregiver burden and caregiver depression is associated with depression of the person with HD and, alongside motor disturbances, depression of the person with HD is one of the main predictors of caregiver burden. Partners of people with HD can also experience reduced satisfaction with their relationship, sometimes more so than the person with HD themselves.
Thus this study will also investigate the views of a family member (e.g. partner, parent, child) of the person participating in the intervention. As the intervention is aimed at alleviating psychological distress in the person with HD, it is hypothesised that this in turn will also have an effect on the family member's wellbeing. Also, higher levels of mindfulness are associated with higher levels of satisfaction in partner relationships, perhaps due to more adaptive conflict resolution and better emotional recognition and management. Participants in MBCT have reported increased empathy and perspective taking, being more able to respond mindfully in relationships. Thus increased mindfulness of the person with HD may benefit family and social relationships.
In addition, caregivers' views about the symptoms or quality of life of the person with HD may not always match the person with HD themselves. Furthermore, certain symptom changes which are beneficial to the person with HD may not be so to the caregiver, and thus the caregiver can offer an alternative perspective of the wellbeing (including behavioural and psychological changes) of the person with HD.
Both qualitative and quantitative data will be collected from a family member or close friend of the person with HD, where such a person is available and willing to take part. Semi-structured interviews with the family member will explore their perceptions on the acceptability of the intervention and experiences of the person with HD, as well as the impact on the family member personally and the wider family system. Data collected pre and post the intervention will assess any changes in their psychological wellbeing, caregiver burden and family relationships, with the hypothesis that wellbeing and relationships will improve post training and caregiver burden will decrease.
- Conditions
- Huntington Disease
- Being tested
- Mindfulness-based cognitive therapy
- Keywords
- depression, anxiety, stress
- Medical subject headings
- Huntington Disease, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based cognitive therapyOther
An 8 week course of mindfulness-based cognitive therapy
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based cognitive therapy | Experimental | Not described Receives: Other: Mindfulness-based cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression post intervention
Change in Hospital Anxiety and Depression Scale (HADS) depression score pre to post intervention (People with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
depression at 3 months
Change in HADS depression score pre to 3 months post intervention
Measured: 3 months post-intervention
depression at 1 year
Change in HADS depression score pre to 1 year post intervention
Measured: 1 year post-intervention
Secondary outcomes (29)
depression mid-course
Change in HADS depression score pre to mid-course (4 weeks after start) (people with HD only)
Measured: 4 weeks after start of intervention
anxiety mid-course
Change in HADS anxiety score pre to mid-course (4 weeks after start) (people with HD only)
Measured: 4 weeks after start of intervention
anxiety post intervention
Change in HADS anxiety score pre to post-intervention (people with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
anxiety at 3 months
Change in HADS anxiety score pre to 3 months post intervention
Measured: 3 months post-intervention
anxiety at 1 year
Change in HADS anxiety score pre to 1 year post intervention
Measured: 1 year post-intervention
stress mid course
Change in Depression Anxiety and Stress Scale (DASS) stress score pre to mid-course (4 weeks after start) (people with HD only)
Measured: 4 weeks after start of intervention
stress post intervention
Change in DASS stress score pre to post course (people with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
stress at 3 months
Change in DASS stress score pre to 3 months post intervention
Measured: 3 months post-intervention
stress at 1 year
Change in DASS stress score pre to 1 year post intervention
Measured: 1 year post-intervention
mindfulness mid-course
Change in Five Factor Mindfulness Questionnaire (FFMQ) score pre to mid-course (4 weeks after start) (people with HD only)
Measured: 4 weeks after start of intervention
mindfulness post intervention
Change in FFMQ score pre to post course (people with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
mindfulness at 3 months
Change in FFMQ score pre to 3 months post intervention
Measured: 3 months post-intervention
mindfulness at 1 year
Change in FFMQ score pre to 1 year post intervention
Measured: 1 year post-intervention
sleep post intervention
Change in Pittsburgh Sleep Quality Index (PSQI) score pre to post course (people with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
sleep at 3 months
Change in PSQI score pre to 3 months post intervention (people with HD only)
Measured: 3 months post-intervention
sleep at 1 year
Change in PSQI score pre to 1 year post intervention (people with HD only)
Measured: 1 year post-intervention
quality of life post intervention
Change in World Health Organisation Quality of Life BREF) score (WHOQOL) pre to post course (people with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
quality of life at 3 months
Change in WHOQOL score pre to 3 months post intervention
Measured: 3 months post-intervention
quality of life at 1 year
Change in WHOQOL score pre to 1 year post intervention
Measured: 1 year post-intervention
positive affect post intervention
Change in Positive And Negative Affect Scale (PANAS) positive items score pre to post course (people with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
positive affect at 3 months
Change in PANAS positive items score pre to 3 months post intervention
Measured: 3 months post-intervention
positive affect at 1 year
Change in PANAS positive items score pre to 1 year post intervention
Measured: 1 year post-intervention
coping post intervention
Change in brief COPE score pre to post course (people with HD only)
Measured: immediately post-intervention (up to two weeks afterwards)
coping at 3 months
Change in brief COPE score pre to 3 months post intervention
Measured: 3 months post-intervention
coping at 1 year
Change in brief COPE score pre to 1 year post intervention
Measured: 1 year post-intervention
relationship satisfaction at 3 months
Change in Relationship Assessment Scale (RAS) score pre to 3 months post intervention (relatives/friends only)
Measured: 3 months post-intervention
relationship satisfaction at 1 year
Change in RAS score pre to 1 year post intervention (relatives/friends only)
Measured: 1 year post-intervention
carer burden at 3 months
Change in carer burden inventory score pre to 3 months post intervention (relatives/friends only)
Measured: 3 months post-intervention
carer burden at 1 year
Change in carer burden inventory score pre to 1 year post intervention (relatives/friends only)
Measured: 1 year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Jane Simpson, Lancaster University
- Investigators
- Jane Simpson, PhD, Principal investigator, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464293
- Sponsor's protocol ID
- EHDN Seed Fund Project 561
- Other IDs
- 15/NW/0238
- Status last verified
- Jan 2020
- First submitted
- 3 Jun 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Arran N, Craufurd D, Simpson J. Illness perceptions, coping styles and psychological distress in adults with Huntington's disease. Psychol Health Med. 2014;19(2):169-79. doi: 10.1080/13548506.2013.802355. Epub 2013 Jun 14.
PubMed 23767964Aoun, S, Kristjanson, L, Oldham, L.The Challenges and Unmet Needs of People with Neurodegenerative Conditions and their Carers. Journal for Community Nurses, 11(1): 17-20, 2006.
Aubeeluck A, Buchanan H. The Huntington's disease quality of life battery for carers: reliability and validity. Clin Genet. 2007 May;71(5):434-45. doi: 10.1111/j.1399-0004.2007.00784.x.
PubMed 17489849Aubeeluck AV, Buchanan H, Stupple EJ. 'All the burden on all the carers': exploring quality of life with family caregivers of Huntington's disease patients. Qual Life Res. 2012 Oct;21(8):1425-35. doi: 10.1007/s11136-011-0062-x. Epub 2011 Nov 13.
PubMed 22081218Banaszkiewicz K, Sitek EJ, Rudzinska M, Soltan W, Slawek J, Szczudlik A. Huntington's disease from the patient, caregiver and physician's perspectives: three sides of the same coin? J Neural Transm (Vienna). 2012 Nov;119(11):1361-5. doi: 10.1007/s00702-012-0787-x. Epub 2012 Mar 8.
PubMed 22398875Barnes S, Brown KW, Krusemark E, Campbell WK, Rogge RD. The role of mindfulness in romantic relationship satisfaction and responses to relationship stress. J Marital Fam Ther. 2007 Oct;33(4):482-500. doi: 10.1111/j.1752-0606.2007.00033.x.
PubMed 17935531Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.
PubMed 19249017Bihari, J, Mullan, E. Relating Mindfully: A Qualitative Exploration of Changes in Relationships Through Mindfulness-Based Cognitive Therapy. Mindfulness 5(1): 46-59, 2014.
Cairns V, Murray C. How do the features of mindfulness-based cognitive therapy contribute to positive therapeutic change? A meta-synthesis of qualitative studies. Behav Cogn Psychother. 2015 May;43(3):342-59. doi: 10.1017/S1352465813000945. Epub 2013 Nov 11.
PubMed 24229765Craufurd, D, Snowden, JS. Neuropsychiatry and Neuropsychology. In G Bates, SJ Tabrizi, L Jones (Eds.), Huntington's disease (4th ed., pp. 36-65). Oxford: Oxford University Press. (2014)
Craufurd D, Thompson JC, Snowden JS. Behavioral changes in Huntington Disease. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):219-26.
PubMed 11725215Dobkin RD, Menza M, Allen LA, Gara MA, Mark MH, Tiu J, Bienfait KL, Friedman J. Cognitive-behavioral therapy for depression in Parkinson's disease: a randomized, controlled trial. Am J Psychiatry. 2011 Oct;168(10):1066-74. doi: 10.1176/appi.ajp.2011.10111669. Epub 2011 Jun 15.
PubMed 21676990Eisendrath SJ, Delucchi K, Bitner R, Fenimore P, Smit M, McLane M. Mindfulness-based cognitive therapy for treatment-resistant depression: a pilot study. Psychother Psychosom. 2008;77(5):319-20. doi: 10.1159/000142525. Epub 2008 Jul 4. No abstract available.
PubMed 18600038Evans SJ, Douglas I, Rawlins MD, Wexler NS, Tabrizi SJ, Smeeth L. Prevalence of adult Huntington's disease in the UK based on diagnoses recorded in general practice records. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1156-60. doi: 10.1136/jnnp-2012-304636. Epub 2013 Mar 12.
PubMed 23482661Fitzpatrick L, Simpson J, Smith A. A qualitative analysis of mindfulness-based cognitive therapy (MBCT) in Parkinson's disease. Psychol Psychother. 2010 Jun;83(Pt 2):179-92. doi: 10.1348/147608309X471514. Epub 2009 Oct 19.
PubMed 19843353
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of Mindfulness-based Cognitive Therapy for People With Huntington's Disease
- ClinicalTrials.gov ID
- NCT02464293
- Acronym / sponsor ID
- EHDN Seed Fund Project 561
- Conditions
- Huntington Disease
- Keywords
- depression, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Jun 2015
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 8 Jun 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.
This is a pilot study to see whether mindfulness-based cognitive therapy, which is a type of psychological therapy, is able to improve the psychological wellbeing of people who have the gene for Huntington's disease.
Detailed description
Huntingdon's disease (HD) is a genetic neurodegenerative condition which causes problems with movement, coordination and cognitive functioning, and emotional difficulties are also commonly experienced. It is believed to affect around five to ten in 100,000 people of European descent, with recent UK estimates as high as 11.2-13.5. Each child of an affected person has a 50% chance of inheriting the condition. As age of diagnosis is typically around 35-55, with time from diagnosis to death around 20 years, those who are diagnosed have often seen their parents affected by the condition.
Many people at various stages of HD (including those who carry the gene but are pre-symptomatic) experience low mood, anxiety and other psychological difficulties. Indeed, alongside functional capacity, mood may be one of the main factors which contributes to health related quality of life, more so than discrete motor problems, or cognitive impairment. In addition, reports from patients suggest emotional and social concerns are important for individuals with the condition at the pre-symptomatic stage, and these concerns remain throughout the disease course. Medication may be effective to alleviate psychological difficulties for some people, but its efficacy has not been conclusively proven and it is not suitable for all. Psychological interventions may provide an alternative or additional way of alleviating distress.
Although it is commonly presumed that biological factors are the main determinants of psychological distress in people with HD, several studies have indicated that, while these may indeed be important, psychological factors are also significant. For example beliefs about the disease and coping mechanisms are associated with poorer mental health and higher levels of depression. Such psychological beliefs and coping patterns can be adaptively changed using psychological interventions, for example cognitive-based psychological therapies.
Little progress has been reported on the development of psychological interventions in HD despite the fact that people with HD have expressed an interest in psychological approaches and these are currently being successfully developed for people with other neurological conditions (e.g., in people with Parkinson's disease). It is therefore proposed to pilot mindfulness-based cognitive therapy (MBCT) which, although originally developed to help people with remitted depression from relapse, has been increasingly used to help people with current difficulties. It has also been piloted with people with Parkinson's disease who found it an acceptable intervention and reported improvements in self-management and psychological wellbeing. In general, MBCT has also recorded other gains including improved sleep quality and social functioning. It has also received sufficient evidence for it to be a recommended approach in the UK NICE guidelines for people with a history of depression. MBCT can also reduce anxiety and provides group support. There are also indications that mindfulness training can improve neurocognitive functioning, even in people with neurodegenerative disease. Finally, a psychological therapy subgroup within the European Huntington's Disease Network has recently been formed, thus indicating the rise of interest in psychological approaches and the timely nature of this work.
Hence this study will provide the first indication of whether MBCT, a therapeutic approach with an established evidence base, would be acceptable and useful for people with HD. In order to meet this aim, MBCT will be delivered to two groups, one to individuals who carry the gene but are pre-symptomatic and one to individuals who have begun to experience symptoms but are at an early stage of the disease course.
Approaches to outcome evaluation should be incremental, with lower cost studies, e.g., qualitative investigations and case studies, being conducted before investment in randomised controlled trials is considered. Thus this study will follow this guidance by collecting both qualitative and quantitative data. The qualitative data will be analysed using interpretative phenomenological analysis, a methodology previously used in other qualitative studies on MBCT. Semi-structured interviews will provide data on the acceptability of the intervention and detailed accounts of participants' experience after the intervention has been provided. This will inform whether the MBCT intervention needs to be changed or adapted in further trials. The quantitative data will be used to provide basic pre and post intervention comparisons on a number of outcome variables relevant to MBCT, with the hypothesis that performance on these measures will improve post training. These data will also be used to estimate effect sizes for further trials so that these are suitably powered.
Given the considerable physical, cognitive and emotional consequences of the disease, HD not only affects the person with HD, but also those with whom they live, even in the pre-clinical phase. Family members often become caregivers and can have a reduced quality of life as a result, including experiencing low mood themselves. In fact, caregiver burden and caregiver depression is associated with depression of the person with HD and, alongside motor disturbances, depression of the person with HD is one of the main predictors of caregiver burden. Partners of people with HD can also experience reduced satisfaction with their relationship, sometimes more so than the person with HD themselves.
Thus this study will also investigate the views of a family member (e.g. partner, parent, child) of the person participating in the intervention. As the intervention is aimed at alleviating psychological distress in the person with HD, it is hypothesised that this in turn will also have an effect on the family member's wellbeing. Also, higher levels of mindfulness are associated with higher levels of satisfaction in partner relationships, perhaps due to more adaptive conflict resolution and better emotional recognition and management. Participants in MBCT have reported increased empathy and perspective taking, being more able to respond mindfully in relationships. Thus increased mindfulness of the person with HD may benefit family and social relationships.
In addition, caregivers' views about the symptoms or quality of life of the person with HD may not always match the person with HD themselves. Furthermore, certain symptom changes which are beneficial to the person with HD may not be so to the caregiver, and thus the caregiver can offer an alternative perspective of the wellbeing (including behavioural and psychological changes) of the person with HD.
Both qualitative and quantitative data will be collected from a family member or close friend of the person with HD, where such a person is available and willing to take part. Semi-structured interviews with the family member will explore their perceptions on the acceptability of the intervention and experiences of the person with HD, as well as the impact on the family member personally and the wider family system. Data collected pre and post the intervention will assess any changes in their psychological wellbeing, caregiver burden and family relationships, with the hypothesis that wellbeing and relationships will improve post training and caregiver burden will decrease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based cognitive therapy | Experimental | Other: Mindfulness-based cognitive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient at Manchester Centre for Genomic Medicine (UK)
- All participants will have had genetic testing and shown to have the requisite CAG expansion on the huntingtin gene.
- Participants must be pre-symptomatic or at stage 1 (still able to function at home and at work and handle financial affairs)
- Clinical sign of depression (score on HADS of 7 or above)
- No significant medication changes in 6 weeks prior to starting the course
Key exclusion criteria (1 listed)
- Active suicidal intent
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 |
|---|---|---|
| Mindfulness-based cognitive therapyAn 8 week course of mindfulness-based cognitive therapy | Other | mindfulness-based cognitive therapy |
Primary outcome
depression post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
Change in Hospital Anxiety and Depression Scale (HADS) depression score pre to post intervention (People with HD only)
depression at 3 months
Time frame: 3 months post-intervention
Change in HADS depression score pre to 3 months post intervention
depression at 1 year
Time frame: 1 year post-intervention
Change in HADS depression score pre to 1 year post intervention
29 secondary outcomes
depression mid-course
Time frame: 4 weeks after start of intervention
anxiety mid-course
Time frame: 4 weeks after start of intervention
anxiety post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
anxiety at 3 months
Time frame: 3 months post-intervention
anxiety at 1 year
Time frame: 1 year post-intervention
stress mid course
Time frame: 4 weeks after start of intervention
stress post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
stress at 3 months
Time frame: 3 months post-intervention
stress at 1 year
Time frame: 1 year post-intervention
mindfulness mid-course
Time frame: 4 weeks after start of intervention
mindfulness post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
mindfulness at 3 months
Time frame: 3 months post-intervention
mindfulness at 1 year
Time frame: 1 year post-intervention
sleep post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
sleep at 3 months
Time frame: 3 months post-intervention
sleep at 1 year
Time frame: 1 year post-intervention
quality of life post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
quality of life at 3 months
Time frame: 3 months post-intervention
quality of life at 1 year
Time frame: 1 year post-intervention
positive affect post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
positive affect at 3 months
Time frame: 3 months post-intervention
positive affect at 1 year
Time frame: 1 year post-intervention
coping post intervention
Time frame: immediately post-intervention (up to two weeks afterwards)
coping at 3 months
Time frame: 3 months post-intervention
coping at 1 year
Time frame: 1 year post-intervention
relationship satisfaction at 3 months
Time frame: 3 months post-intervention
relationship satisfaction at 1 year
Time frame: 1 year post-intervention
carer burden at 3 months
Time frame: 3 months post-intervention
carer burden at 1 year
Time frame: 1 year post-intervention
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 7 Jan 2020.
- Background: PubMed 23767964Arran N, Craufurd D, Simpson J. Illness perceptions, coping styles and psychological distress in adults with Huntington's disease. Psychol Health Med. 2014;19(2):169-79. doi: 10.1080/13548506.2013.802355. Epub 2013 Jun 14.
- BackgroundAoun, S, Kristjanson, L, Oldham, L.The Challenges and Unmet Needs of People with Neurodegenerative Conditions and their Carers. Journal for Community Nurses, 11(1): 17-20, 2006.
- Background: PubMed 17489849Aubeeluck A, Buchanan H. The Huntington's disease quality of life battery for carers: reliability and validity. Clin Genet. 2007 May;71(5):434-45. doi: 10.1111/j.1399-0004.2007.00784.x.
- Background: PubMed 22081218Aubeeluck AV, Buchanan H, Stupple EJ. 'All the burden on all the carers': exploring quality of life with family caregivers of Huntington's disease patients. Qual Life Res. 2012 Oct;21(8):1425-35. doi: 10.1007/s11136-011-0062-x. Epub 2011 Nov 13.
- Background: PubMed 22398875Banaszkiewicz K, Sitek EJ, Rudzinska M, Soltan W, Slawek J, Szczudlik A. Huntington's disease from the patient, caregiver and physician's perspectives: three sides of the same coin? J Neural Transm (Vienna). 2012 Nov;119(11):1361-5. doi: 10.1007/s00702-012-0787-x. Epub 2012 Mar 8.
- Background: PubMed 17935531Barnes S, Brown KW, Krusemark E, Campbell WK, Rogge RD. The role of mindfulness in romantic relationship satisfaction and responses to relationship stress. J Marital Fam Ther. 2007 Oct;33(4):482-500. doi: 10.1111/j.1752-0606.2007.00033.x.
- Background: PubMed 19249017Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.
- BackgroundBihari, J, Mullan, E. Relating Mindfully: A Qualitative Exploration of Changes in Relationships Through Mindfulness-Based Cognitive Therapy. Mindfulness 5(1): 46-59, 2014.
- Background: PubMed 24229765Cairns V, Murray C. How do the features of mindfulness-based cognitive therapy contribute to positive therapeutic change? A meta-synthesis of qualitative studies. Behav Cogn Psychother. 2015 May;43(3):342-59. doi: 10.1017/S1352465813000945. Epub 2013 Nov 11.
- BackgroundCraufurd, D, Snowden, JS. Neuropsychiatry and Neuropsychology. In G Bates, SJ Tabrizi, L Jones (Eds.), Huntington's disease (4th ed., pp. 36-65). Oxford: Oxford University Press. (2014)
- Background: PubMed 11725215Craufurd D, Thompson JC, Snowden JS. Behavioral changes in Huntington Disease. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):219-26.
- Background: PubMed 21676990Dobkin RD, Menza M, Allen LA, Gara MA, Mark MH, Tiu J, Bienfait KL, Friedman J. Cognitive-behavioral therapy for depression in Parkinson's disease: a randomized, controlled trial. Am J Psychiatry. 2011 Oct;168(10):1066-74. doi: 10.1176/appi.ajp.2011.10111669. Epub 2011 Jun 15.
- Medical Research Council. (2008). Developing and evaluating complex interventions: new guidance.Link provided by the sponsor.
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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.
Jane Simpson, PhD principal investigator
Lancaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based cognitive therapy in people with Huntington Disease, run by Lancaster University 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 8 inclusion and 1 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 7 Jan 2020. 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?
depression post intervention (time frame: immediately post-intervention (up to two weeks afterwards)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464293, which also lists 47 linked publications.
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 7 Jan 2020.