ACT for ME/CFS - an Open Case Trial
Primary Purpose
Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome
Eligibility 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
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ACT
Arm Description
Acceptance & Commitment Therapy (ACT)
Outcomes
Primary Outcome Measures
ME/CFS Disability Index (changes between assessments)
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).
Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)
Self-rated psychological inflexibility related to fatigue
Secondary Outcome Measures
ME/CFS Symptoms (changes between assessments)
Self-reported prevalence and intensity (0-4) of ME/CFS symptoms based on the 2003 clinical case definition (0=symptom absence, 4=unbearable).
Full Information
NCT ID
NCT03562325
First Posted
June 8, 2018
Last Updated
June 8, 2018
Sponsor
Rikard Wicksell
Collaborators
Region Stockholm, Skandia Insurance Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03562325
Brief Title
ACT for ME/CFS - an Open Case Trial
Official Title
Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) - an Open Case Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2012 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rikard Wicksell
Collaborators
Region Stockholm, Skandia Insurance Company, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open case trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACT
Arm Type
Other
Arm Description
Acceptance & Commitment Therapy (ACT)
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
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 Measure Information:
Title
ME/CFS Disability Index (changes between assessments)
Description
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).
Time Frame
Baseline to 6-month follow-up
Title
Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)
Description
Self-rated psychological inflexibility related to fatigue
Time Frame
Baseline to 6-month follow-up
Secondary Outcome Measure Information:
Title
ME/CFS Symptoms (changes between assessments)
Description
Self-reported prevalence and intensity (0-4) of ME/CFS symptoms based on the 2003 clinical case definition (0=symptom absence, 4=unbearable).
Time Frame
Baseline to 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikard Wicksell, PhD
Organizational Affiliation
Director of Functional Area Medical Psychology, Karolinska Univ Hospital, assoc professor and head of research group Behavior Medcine, Karolinska Institutet, Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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ACT for ME/CFS - an Open Case Trial
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