ACT for ME/CFS - an Open Case Trial

NCT03562325 | Completed

• 1 other identifier: 2015/370-31/4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• ME/CFS Symptoms (changes between assessments)

  Baseline to 6-month follow-up

Study Arms (1)

ACT

OTHER

Acceptance \& Commitment Therapy (ACT)

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

ACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to a specialist behavior medicine treatment unit for ME/CFS
• 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

You may not qualify 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

Sponsors & Collaborators

• Rikard Wicksell: lead
• Region Stockholm: collaborator
• Skandia Insurance Company, Ltd.: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open case trial

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 19, 2018
• Study Start: November 10, 2012
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)