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

NCT02464293 | Completed

• 2 other identifiers: EHDN Seed Fund Project 56115/NW/0238
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington Disease

Keywords

depression; anxiety; stress

Outcome Measures

Primary Outcomes (3)

• depression post intervention

  Change in Hospital Anxiety and Depression Scale (HADS) depression score pre to post intervention (People with HD only)

  immediately post-intervention (up to two weeks afterwards)

• depression at 3 months

  Change in HADS depression score pre to 3 months post intervention

  3 months post-intervention

• depression at 1 year

  Change in HADS depression score pre to 1 year post intervention

  1 year post-intervention

Secondary Outcomes (29)

• depression mid-course

  4 weeks after start of intervention

• anxiety mid-course

  4 weeks after start of intervention

• anxiety post intervention

  immediately post-intervention (up to two weeks afterwards)

• anxiety at 3 months

  3 months post-intervention

• anxiety at 1 year

  1 year post-intervention

Study Arms (1)

mindfulness-based cognitive therapy

EXPERIMENTAL

Other: Mindfulness-based cognitive therapy

Interventions

Mindfulness-based cognitive therapy OTHER

An 8 week course of mindfulness-based cognitive therapy

mindfulness-based cognitive therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Active suicidal intent

Sponsors & Collaborators

• Lancaster University: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Central Manchester University Hospitals NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (47)

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  PMID: 32595978 DERIVED

Related Links

• Medical Research Council. (2008). Developing and evaluating complex interventions: new guidance.

MeSH Terms

Conditions

Huntington Disease; Depression; Anxiety Disorders

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jane Simpson, PhD

  Lancaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Doctorate in Clinical Psychology

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: June 1, 2015
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

GB (1)