An interventional study of Acceptance and Commitment Therapy (ACT) in Chronic Fatigue Syndrome, sponsored by Rikard Wicksell. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Rikard Wicksell · Not applicable, Interventional, and Treatment
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.
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.
263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 177 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Rikard Wicksell is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Subjects were included if
Exclusion Criteria: Subjects were excluded if:
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.
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).
Time frame: Baseline to 6-month follow-up
Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)
Self-rated psychological inflexibility related to fatigue
Time frame: Baseline to 6-month follow-up
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).
Time frame: Baseline to 6-month follow-up
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2012 to primary completion in Oct 2017, 59 months.
Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 59 months is above that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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