Chronic Fatigue SyndromeNCT03562325
ACT for ME/CFS - an Open Case Trial
A study testing Acceptance and Commitment Therapy (ACT) in people with Chronic Fatigue Syndrome, run by Rikard Wicksell at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 10 Nov 2012to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Acceptance and Commitment Therapy (ACT)
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT | Other | Acceptance \& Commitment Therapy (ACT) Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 6-month follow-up
Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)
Self-rated psychological inflexibility related to fatigue
Measured: Baseline to 6-month follow-up
Secondary outcomes (1)
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).
Measured: Baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start10 Nov 2012
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open case trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rikard Wicksell
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Skandia Insurance Company, Ltd.
- Responsible party
- Sponsor-investigator, Rikard Wicksell, Karolinska Institutet
- Investigators
- Rikard Wicksell, PhD, Study director, Director of Functional Area Medical Psychology, Karolinska Univ Hospital, assoc professor and head of research group Behavior Medcine, Karolinska Institutet, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562325
- Sponsor's protocol ID
- 2015/370-31/4
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) - an Open Case Trial
- ClinicalTrials.gov ID
- NCT03562325
- Acronym / sponsor ID
- 2015/370-31/4
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rikard WicksellUniversity, hospital or other
- Collaborators
- Region Stockholm, Skandia Insurance Company, Ltd.
- Study start
- 10 Nov 2012 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open case trial
| Arm | Type | Receives |
|---|---|---|
| ACT | Other | Behavioral: Acceptance and Commitment Therapy (ACT)Acceptance \& Commitment Therapy (ACT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT |
Primary outcome
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).
Psychological Inflexibility in Fatigue Scale (PIFS) (changes between assessments)
Time frame: Baseline to 6-month follow-up
Self-rated psychological inflexibility related to fatigue
1 secondary outcome
ME/CFS Symptoms (changes between assessments)
Time frame: Baseline to 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Fatigue Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Active, not recruiting
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Chronic Insomnia, Cancer-related Problem/Condition
RecruitingPhase 2
LIFT: Life Improvement Trial
ME/CFS, Long COVID
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikard Wicksell, PhD study director
Director of Functional Area Medical Psychology, Karolinska Univ Hospital, assoc professor and head of research group Behavior Medcine, Karolinska Institutet, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) in people with Chronic Fatigue Syndrome, run by Rikard Wicksell at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ME/CFS Disability Index (changes between assessments) (time frame: Baseline to 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.