ACT for ME/CFS - an Open Case Trial

Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) - an Open Case Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT)

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 77
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to 6-month follow-up
Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)	Self-rated psychological inflexibility related to fatigue	Baseline to 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to 6-month follow-up

Collaborators and Investigators

• Sponsor: Rikard Wicksell
• Collaborators: Region Stockholm; 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

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2012
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 2015/370-31/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No