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ACT for ME/CFS - an Open Case Trial

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ClinicalTrials.gov Identifier: NCT03562325
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Skandia Insurance Company, Ltd.
Information provided by (Responsible Party):
Rikard Wicksell, Karolinska Institutet

Brief Summary:
The goal of this research project is to evaluate if our well-researched behavior medicine treatment model for chronic pain, based on Acceptance and Commitment Therapy, is safe and effective in increasing quality of life and functioning also in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). To date there are no effective treatments for ME/CFS as the ethology and pathophysiology are unknown, while levels of functioning and quality of life as well as secondary effects such as depressive and anxiety symptoms indicate a highly affected patient population. As such, there is a need for behavior medicine approaches that aim to alleviate suffering and promote increases in quality of life for these patients. The aim of the present study is to do a preliminary evaluation of the safety, acceptability and efficacy of an ACT-based treatment protocol for ME/CFS. An additional aim is to explore potential mediators of change for the effect of treatment on disability.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Behavioral: Acceptance and Commitment Therapy (ACT) Not Applicable

Detailed Description:

Background Medical strategies alone appear insufficient to increase functioning and quality of life in ME/CFS. Cognitive behavioral therapy (CBT) is the only treatment approach with preliminary evidence of efficacy for improving functioning and quality of life. However, effect sizes are generally modest.

Behavior medicine treatment approaches based on Acceptance & Commitment Therapy (ACT) have gained increasing attention and research support within clinical trials for similar diagnoses (e.g. chronic pain, Fibromyalgia). Results from these areas illustrate the utility of this approach for individuals with somatic symptomatology. To date, the efficacy of ACT has not been evaluated for ME/CFS.

Purpose The aims of this pilot study are to explore the utility of ACT and to evaluate the feasibility of the treatment model for patients with ME/CFS.

Method Treatment program: 13 weekly to bi-weekly individual ACT sessions with a psychologist (10) and a physician (3) respectively.

An open trial design is used, with assessments at pre-, mid- and post-treatment as well as at 3 and 6 months follow-up. Further, yearly follow-ups until 5-year follow-up are planned.

Measures: History data, illness factors, psychological factors, functioning and quality of life.

Patients: Consecutively recruited via referrals to a specialist treatment centre (n=40). Once patients have been found eligible and expressed interest in study participation they will be assessed by a psychologist and by a physician, via semi-structured interviews to confirm eligibility and to ensure that the patient meet the study criteria. Informed consent is obtained from all participants prior to the assessment.

Statistical analysis: Evaluations of treatment effects are primarily based on intent-to-treat analyses. The statistical approach will primarily be based on linear multilevel modeling (LMM), which takes into account dependencies between repeated measures and differences between patients in pre-treatment status and treatment response (i.e. random effects modeling) and also provide means of handling missing data.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open case trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) - an Open Case Trial
Actual Study Start Date : November 10, 2012
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ACT
Acceptance & Commitment Therapy (ACT)
Behavioral: Acceptance and Commitment Therapy (ACT)
The main target in ACT for ME/CFS (as for Fibromyalgia and Chronic pain in previous studies by our group) is to promote a shift of perspective in life from symptom reduction (when it does not work) to a valued life. As such it entails acceptance and exposure to discomfort, in order to lessen the effects of negative experiences (symptoms, emotions, thoughts) on behaviours in everyday life.




Primary Outcome Measures :
  1. ME/CFS Disability Index (changes between assessments) [ Time Frame: Baseline to 6-month follow-up ]
    Self-reported ME/CFS-related disability in 7 life domains (domestic; recreational activities; social activities; occupational; sexual life; daily activities; life-sustaining activities). Each item is scored 0-10 (0= no disability, 10=total disability).

  2. Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments) [ Time Frame: Baseline to 6-month follow-up ]
    Self-rated psychological inflexibility related to fatigue


Secondary Outcome Measures :
  1. ME/CFS Symptoms (changes between assessments) [ Time Frame: Baseline to 6-month follow-up ]
    Self-reported prevalence and intensity (0-4) of ME/CFS symptoms based on the 2003 clinical case definition (0=symptom absence, 4=unbearable).



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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: Subjects were included if

  • Referred to a specialist behavior medicine treatment unit for ME/CFS
  • 18 years of age or older
  • Fulfilling CDC ME/CFS diagnostic criteria AND 2003 clinical case definition ME/CFS diagnostic criteria
  • Treatment resistent symptomatology
  • Evident ME/CFS-related disability (assessed with self-report questionnaires and clinical interviews)
  • Stabile medication during the last 2 months with no planned changes during active study treatment

Exclusion Criteria: Subjects were excluded if:

  • psychiatric or somatic comorbidity was prevalent and assessed as more primary than ME/CFS illness;
  • non-adherence during assessment phase;
  • they did not speak Swedish;
  • ongoing or recently (less than six months) completed CBT-oriented treatment;
  • other treatment than standard care (pharmacological, psychological or otherwise) planned in the coming six months

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): NCT03562325


Locations
Sweden
Karolinska Institutet
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Rikard Wicksell
Stockholm County Council, Sweden
Skandia Insurance Company, Ltd.
Investigators
Study Director: Rikard Wicksell, PhD Director of Functional Area Medical Psychology, Karolinska Univ Hospital, assoc professor and head of research group Behavior Medcine, Karolinska Institutet, Karolinska Institutet

Responsible Party: Rikard Wicksell, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03562325     History of Changes
Other Study ID Numbers: 2015/370-31/4
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases