Acceptance and Commitment Therapy for Muscle Disease (ACTMuS)
|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.|
|ClinicalTrials.gov Identifier: NCT02810028|
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Muscle Diseases||Behavioral: Acceptance and Commitment Therapy (ACT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Acceptance and Commitment Therapy for Muscle Disease|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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.
- 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.
- 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.
- 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.
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
|Contact: Trudie Chalder||020 7848 email@example.com|
|Contact: Nicola O'Connell||020 7848 firstname.lastname@example.org|
|King's College Hospital; The Royal London Hospital; University Hospital Southampton; King's College London||Recruiting|
|London, United Kingdom|
|Contact: Nicola O'Connell 020 7848 8462 email@example.com|
|Principal Investigator: Michael Rose|
|Sub-Investigator: Trudie Chalder|
|Sub-Investigator: Lance McCracken|
|Sub-Investigator: Christopher Graham|
|Sub-Investigator: Sam Norton|
|Sub-Investigator: Aleksandar Radunovic|
|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|