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Acceptance and Commitment Therapy for Muscle Disease (ACTMuS)

This study is currently recruiting participants.
Verified June 2016 by King's College Hospital NHS Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02810028
First Posted: June 22, 2016
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
King's College London
Barts & The London NHS Trust
Muscular Dystrophy UK
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
King's College Hospital NHS Trust
  Purpose
In adults, muscle diseases are usually chronic long-term conditions that do not have a definitive cure. Supportive care has been shown to reduce complications from muscle disease and improved survival in some cases. However, there has been limited research to evaluate interventions that may improve quality of life (QoL) with this patient group. The QoL of those with MD is not just affected by the severity of their MD but also a variety of psychological variables. Based upon the knowledge of these psychological variables the investigators feel that a particular type of psychological intervention known as "acceptance and commitment therapy" (ACT) could potentially improve QoL in those with MD. The investigators therefore propose to test whether ACT does in fact improve QoL in those with MD by randomising 154 patients to receive either standard medical care plus a guided self-help ACT programme, or standard medical care only.

Condition Intervention
Muscle Diseases Behavioral: Acceptance and Commitment Therapy (ACT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy for Muscle Disease

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Life areas [ Time Frame: 9 weeks post randomisation ]
    Measures impact of MD on life areas: activities, independence, social functioning, emotional functioning and body image.


Secondary Outcome Measures:
  • Individualised Neuromuscular Quality of Life Questionnaire (INQoL) - Symptom impact domains [ Time Frame: 9 weeks post randomisation ]
    Measures the impact of key muscle disease symptoms: weakness, fatigue and pain.

  • Work and Social Adjustment Scale (WSAS) [ Time Frame: 9 weeks post randomisation ]
    Assesses how much symptoms interfere with participation in life i.e. work, home management, social, private and relationships.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 9 weeks post randomisation ]
    Measures mood.

  • Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: 9 weeks post randomisation ]
    Measures functional impairment.

  • Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: 9 weeks post randomisation ]
    Measures psychological flexibility.

  • Mindfulness Attention Awareness Scale (MAAS) [ Time Frame: 9 weeks post randomisation ]
    Measures dispositional open awareness of and attention to the present moment.

  • Committed Action Scale (CAS) [ Time Frame: 9 weeks post randomisation ]
    Measures commitment towards goals.

  • IBM Functional Rating Scale [ Time Frame: 9 weeks post randomisation ]
    Assesses function in people with Inclusion Body Myositis.

  • Patient Global Impression of Change scale (PGIC) [ Time Frame: 9 weeks post randomisation ]
    Assesses patient's own impression of change during the course of the study.

  • Patient rating of treatment satisfaction [ Time Frame: 9 weeks post randomisation ]
    Measures patient's satisfaction with the treatment they have received.


Other Outcome Measures:
  • 6-minute timed walk test [ Time Frame: Baseline only ]
    Measures mobility.

  • Adult Ambulatory Neuromuscular Assessment (AANA) [ Time Frame: Baseline only ]
    An adult version of the North Star Ambulatory Assessment that measures motor function.

  • Manual Muscle Strength Testing (MMST) [ Time Frame: Baseline only ]
    Measures muscle strength.


Estimated Enrollment: 154
Study Start Date: July 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT + Standard Medical Care (SMC)
This consists of 4 self-guided psycho-education modules supported by weekly telephone contact with a health professional trained in Acceptance and Commitment Therapy (ACT). Standard medical care will be provided as usual.
Behavioral: Acceptance and Commitment Therapy (ACT)
Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy focused explicitly on promoting psychological flexibility. An ACT programme suits the aims of the study because it targets avoidance of distress, promotes acceptance of illness through motivating meaningful activity outside of illness, improves the processes that underlie beliefs rather than by directly challenging beliefs, thus reducing possible trivialisation of the understandable distress caused by living with MD.
No Intervention: Standard Medical Care (SMC)
All participants will receive SMC. As such, they will receive all the treatment and support they would otherwise receive outside of a research trial including a personalised assessment from the physiotherapist.

Detailed Description:

Previous research has shown that while QoL is determined by the severity of the MD, this does not explain all aspects of the reduced QoL of those with MD. Previous research suggested that a cognitive behavioural approach using Acceptance and Commitment Therapy (ACT) would best suit those with MD. A pilot study of this approach in seven participants with MD was promising, and has led to this definitive trial of ACT. The aim of this study is to determine the efficacy of an ACT intervention to improve the QoL of individuals with MD.

Patients with one of the following muscle diseases will be recruited: limb girdle muscular dystrophy, dystrophinopathies resulting in a Becker' muscular dystrophy phenotype, facioscapulohumeral muscular dystrophy and inclusion body myositis. Patients will be recruited primarily through muscle clinics at King's College Hospital (KCH) and The Royal London Hospital (RLH) but also via Muscular Dystrophy UK (MDUK) and UK registries of patients with these muscle diseases.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Diagnosed with one of four specific muscle diseases on the basis of diagnostic criteria:

    1. Limb girdle muscular dystrophy; symptomatic limb girdle muscular dystrophy genetically or pathologically proven
    2. Dystrophinopathies resulting in a Becker' muscular dystrophy phenotype (excluding Duchenne muscular dystrophy) with pathology or genetic diagnosis
    3. Facioscapulohumeral muscular dystrophy diagnosed clinically with specific genetic abnormality in the subject or their family
    4. Inclusion body myositis clinic-pathologically defined, clinically defined or probable IBM based on ENMC research diagnostic criteria 2013 (submitted)
  2. duration of muscle disease greater than six months
  3. over the age of 18 years
  4. access to the internet and a computer on which they can receive the intervention materials
  5. HADS scores > 8 for depression or >8 for anxiety

Exclusion Criteria:

  1. Major active co-morbidities unrelated to muscle disease such as arthritis, respiratory disease, cardiovascular disease
  2. Unstable complications of muscle disease including:

    1. neuromuscular respiratory weakness
    2. cardiomyopathy
  3. Cognitive impairment that prevents comprehension of the questionnaires; assessed using the Montreal Cognitive Assessment
  4. Unable to read English questionnaires
  5. Major diagnosed active mental health co-morbidities e.g. psychosis, major depression, obsessive compulsive disorder, active suicide risk
  6. Current or recent participation in other treatment intervention studies (< 4 weeks after completion)
  7. Currently receiving psychological support or psychotherapy
  Contacts and Locations
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): NCT02810028


Contacts
Contact: Trudie Chalder 020 7848 0406 trudie.chalder@kcl.ac.uk
Contact: Chiara Vari 0782 597 8905 chiara.vari@kcl.ac.uk

Locations
United Kingdom
King's College Hospital; The Royal London Hospital; King's College London Recruiting
London, United Kingdom
Contact: Chiara Vari    0782 597 8905    chiara.vari@kcl.ac.uk   
Contact: Victoria Edwards    020 7848 8462    victoria.1.edwards@kcl.ac.uk   
Principal Investigator: Michael Rose         
Sub-Investigator: Trudie Chalder         
Sub-Investigator: Lance McCracken         
Sub-Investigator: Christopher Graham         
Sub-Investigator: Sam Norton         
Sub-Investigator: Aleksandar Radunovic         
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London
Barts & The London NHS Trust
Muscular Dystrophy UK
University Hospital Southampton NHS Foundation Trust
Investigators
Principal Investigator: Michael Rose King's College Hospital NHS Trust
Principal Investigator: Trudie Chalder King's College London
Principal Investigator: Lance McCracken King's College London
Principal Investigator: Christopher Graham University of Leeds
Principal Investigator: Sam Norton King's College London
Principal Investigator: Aleksandar Radunovic Barts & The London NHS Trust
  More Information

Publications:
Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02810028     History of Changes
Other Study ID Numbers: PB-PG-061331085
First Submitted: June 20, 2016
First Posted: June 22, 2016
Last Update Posted: October 11, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by King's College Hospital NHS Trust:
Limb girdle muscular dystrophy
Becker's muscular dystrophy
Facioscapulohumeral muscular dystrophy
Inclusion-body myositis
Acceptance and Commitment Therapy
ACT

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases