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A Pilot Evaluation of Mindfulness-based Cognitive Therapy for People With Huntington's Disease

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ClinicalTrials.gov Identifier: NCT02464293
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
Dr Jane Simpson, Lancaster University

Brief 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.

Condition or disease Intervention/treatment Phase
Huntington Disease Other: Mindfulness-based cognitive therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Evaluation of Mindfulness-based Cognitive Therapy for People With Huntington's Disease
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mindfulness-based cognitive therapy Other: Mindfulness-based cognitive therapy
An 8 week course of mindfulness-based cognitive therapy




Primary Outcome Measures :
  1. 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)

  2. depression at 3 months [ Time Frame: 3 months post-intervention ]
    Change in HADS depression score pre to 3 months post intervention

  3. depression at 1 year [ Time Frame: 1 year post-intervention ]
    Change in HADS depression score pre to 1 year post intervention


Secondary Outcome Measures :
  1. depression mid-course [ Time Frame: 4 weeks after start of intervention ]
    Change in HADS depression score pre to mid-course (4 weeks after start) (people with HD only)

  2. anxiety mid-course [ Time Frame: 4 weeks after start of intervention ]
    Change in HADS anxiety score pre to mid-course (4 weeks after start) (people with HD only)

  3. anxiety post intervention [ Time Frame: immediately post-intervention (up to two weeks afterwards) ]
    Change in HADS anxiety score pre to post-intervention (people with HD only)

  4. anxiety at 3 months [ Time Frame: 3 months post-intervention ]
    Change in HADS anxiety score pre to 3 months post intervention

  5. anxiety at 1 year [ Time Frame: 1 year post-intervention ]
    Change in HADS anxiety score pre to 1 year post intervention

  6. stress mid course [ Time Frame: 4 weeks after start of intervention ]
    Change in Depression Anxiety and Stress Scale (DASS) stress score pre to mid-course (4 weeks after start) (people with HD only)

  7. stress post intervention [ Time Frame: immediately post-intervention (up to two weeks afterwards) ]
    Change in DASS stress score pre to post course (people with HD only)

  8. stress at 3 months [ Time Frame: 3 months post-intervention ]
    Change in DASS stress score pre to 3 months post intervention

  9. stress at 1 year [ Time Frame: 1 year post-intervention ]
    Change in DASS stress score pre to 1 year post intervention

  10. mindfulness mid-course [ Time Frame: 4 weeks after start of intervention ]
    Change in Five Factor Mindfulness Questionnaire (FFMQ) score pre to mid-course (4 weeks after start) (people with HD only)

  11. mindfulness post intervention [ Time Frame: immediately post-intervention (up to two weeks afterwards) ]
    Change in FFMQ score pre to post course (people with HD only)

  12. mindfulness at 3 months [ Time Frame: 3 months post-intervention ]
    Change in FFMQ score pre to 3 months post intervention

  13. mindfulness at 1 year [ Time Frame: 1 year post-intervention ]
    Change in FFMQ score pre to 1 year post intervention

  14. sleep post intervention [ Time Frame: immediately post-intervention (up to two weeks afterwards) ]
    Change in Pittsburgh Sleep Quality Index (PSQI) score pre to post course (people with HD only)

  15. sleep at 3 months [ Time Frame: 3 months post-intervention ]
    Change in PSQI score pre to 3 months post intervention (people with HD only)

  16. sleep at 1 year [ Time Frame: 1 year post-intervention ]
    Change in PSQI score pre to 1 year post intervention (people with HD only)

  17. quality of life post intervention [ Time Frame: immediately post-intervention (up to two weeks afterwards) ]
    Change in World Health Organisation Quality of Life BREF) score (WHOQOL) pre to post course (people with HD only)

  18. quality of life at 3 months [ Time Frame: 3 months post-intervention ]
    Change in WHOQOL score pre to 3 months post intervention

  19. quality of life at 1 year [ Time Frame: 1 year post-intervention ]
    Change in WHOQOL score pre to 1 year post intervention

  20. positive affect post intervention [ Time Frame: immediately post-intervention (up to two weeks afterwards) ]
    Change in Positive And Negative Affect Scale (PANAS) positive items score pre to post course (people with HD only)

  21. positive affect at 3 months [ Time Frame: 3 months post-intervention ]
    Change in PANAS positive items score pre to 3 months post intervention

  22. positive affect at 1 year [ Time Frame: 1 year post-intervention ]
    Change in PANAS positive items score pre to 1 year post intervention

  23. coping post intervention [ Time Frame: immediately post-intervention (up to two weeks afterwards) ]
    Change in brief COPE score pre to post course (people with HD only)

  24. coping at 3 months [ Time Frame: 3 months post-intervention ]
    Change in brief COPE score pre to 3 months post intervention

  25. coping at 1 year [ Time Frame: 1 year post-intervention ]
    Change in brief COPE score pre to 1 year post intervention

  26. relationship satisfaction at 3 months [ Time Frame: 3 months post-intervention ]
    Change in Relationship Assessment Scale (RAS) score pre to 3 months post intervention (relatives/friends only)

  27. relationship satisfaction at 1 year [ Time Frame: 1 year post-intervention ]
    Change in RAS score pre to 1 year post intervention (relatives/friends only)

  28. carer burden at 3 months [ Time Frame: 3 months post-intervention ]
    Change in carer burden inventory score pre to 3 months post intervention (relatives/friends only)

  29. carer burden at 1 year [ Time Frame: 1 year post-intervention ]
    Change in carer burden inventory score pre to 1 year post intervention (relatives/friends only)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Active suicidal intent

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): NCT02464293


Locations
United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
Sponsors and Collaborators
Lancaster University
Manchester University NHS Foundation Trust
Investigators
Principal Investigator: Jane Simpson, PhD Lancaster University

Additional Information:
Publications:
Aoun, 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.
Bihari, J, Mullan, E. Relating Mindfully: A Qualitative Exploration of Changes in Relationships Through Mindfulness-Based Cognitive Therapy. Mindfulness 5(1): 46-59, 2014.
Craufurd, 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)
Kaptein, A.A, Helder, DI, Scharloo, M, Van Kempen, GMJ, Weinman, J, Van Houwelingen, HJC, Roos, RAC. Illness perceptions and coping explain well-being in patients with Huntington's disease. Psychology & Health, 21(4): 431-446. (2006)
Kay, C, Fisher, E, Hayden, MR. Epidemiology. In G. Bates, S. J. Tabrizi & L. Jones (Eds.), Huntington's disease (4th ed., pp. 131-164). Oxford: Oxford University Press. 2014.
Pickett T, Altmaier E, Paulsen, JS. Caregiver burden in Huntington's disease. Rehabilitation Psychology 52(3): 311-318. 2007.
Ree MJ, Craigie M A. Outcomes following mindfulness-based cognitive therapy in a heterogeneous sample of adult outpatients. Behavior Change 24(2): 70-86, 2007.
Smith JA. Interpretative phenomenological analysis : theory, method and research. London: Sage. 2009.
Teasdale JD, Williams JMG, Segal, ZV. The Mindful Way Workbook: An 8-week Program to Free Yourself from Depression and Emotional Distress. New York, New York: Guildford Press. 2014.

Responsible Party: Dr Jane Simpson, Research Director, Doctorate in Clinical Psychology, Lancaster University
ClinicalTrials.gov Identifier: NCT02464293     History of Changes
Other Study ID Numbers: EHDN Seed Fund Project 561
15/NW/0238 ( Other Identifier: NHS National Research Ethics Service REC )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017

Keywords provided by Dr Jane Simpson, Lancaster University:
depression
anxiety
stress

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders