Clinical Trial: Acceptance and Commitment Therapy for Muscle Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Acceptance and Commitment Therapy for Muscle Disease

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: King's College Hospital NHS Trust

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: King's College Hospital NHS Trust

Dates:
Date Received: June 20, 2016
Date Started: July 2016
Date Completion: July 2018
Last Updated: February 15, 2017
Last Verified: June 2016