Characterization, Treatment, and Long-term Follow-up of Fatigued Patients in Primary Care (iFAS)

March 9, 2026 updated by: Elin Lindsäter, Karolinska Institutet

The overarching purpose of this project is to further the understanding of fatigue as a symptom in primary care patients, and to build evidence for a highly accessible treatment targeting fatigue that can be readily implemented in primary care clinics.

Data will be collected within a randomized controlled superiority trial. The primary aim is to evaluate the effectiveness of a transdiagnostic cognitive behavioral therapy (tCBT) for fatigued patients as compared to care as usual (CAU). Primary outcome will be change in fatigue severity (as measured by the Checklist Individual Strengths, fatigue subscale) pre- to post-treatment (6 months), with long-term controlled follow-up after 12 months. A register-based follow-up will be conducted up to 60 months post baseline. Moderators and mechanisms of treatment effect will be investigated with the aim to identify potential subgroups of fatigued individuals across and within diagnostic categories that may respond differently to treatment. Lastly, a health economic evaluation of long-term treatment effects will be conducted, which incorporates much needed detailed mapping of care as usual for fatigued patients.

Study Overview

Detailed Description

Background:

Fatigue can be defined as extreme and persistent tiredness, weakness, or exhaustion that that could be mental physical, or both. Fatigue is associated with increased healthcare consumption, work disability, and excess mortality, and has been studied extensively under different labels since the 1800's (e.g., neurasthenia, burnout, chronic fatigue syndrome). Studies in primary care populations indicate that about 20-30% of patients report fatigue, with up to 10% of patients presenting with fatigue as their main complaint. Although often considered a disorder-specific characteristic, the etiology and pathogenesis of fatigue are largely unknown and are generally believed to be multifactorial. No biological markers or other objectively measurable factors (such as cognitive impairment) have been found thus far that consistently and sufficiently explain the onset and perpetuation of disorder-specific fatigue. The high prevalence and non-specific nature of fatigue presents a challenge to general practitioners who generally have limited time and resources for assessment and intervention.

Importantly, a potential break-through to how we can understand fatigue has been achieved in recent years, with studies showing that variance in fatigue severity is better explained by transdiagnostic factors (i.e., factors not attributable to a specific medical condition, such as demographic and psychosocial variables and aspects of daily functioning) than by disorder-specific pathophysiology. Further, similar cognitive and behavioral perpetuating mechanisms of fatigue (such as fear avoidance, symptom catastrophizing, self-efficacy, and resting-behavior) have been found across disorders. These findings suggest that a transdiagnostic approach to understanding and treating persistent fatigue might be beneficial for patients and healthcare practitioners, with potentially important implications for treatment.

Treatment of fatigue:

As with other aspects of fatigue, intervention research on fatigue has primarily been conducted in disorder-specific pipelines using disorder-specific protocols. CBT is the most studied treatment, with promising effects for patients with, for example, chronic fatigue syndrome, post-infectious fatigue, and various long-term medical conditions where fatigue is often central (both face-to-face and when delivered via the internet; ICBT). Results from previous RCTs conducted by the investigators have indicated that CBT can be an effective treatment to reduce symptom burden in patients diagnosed with stress-induced exhaustion disorder. Importantly, disorder-specific CBT-protocols for fatigue are largely similar across clinical groups, and the same cognitive and behavioral responses to fatigue have been found to moderate and mediate fatigue severity after CBT across a range of fatigued patient groups.

Even though CBT may hold promise to reduce fatigue severity in different clinical groups, many fatigued patients still do not receive treatment, and not all patients who receive CBT are sufficiently helped. Further research is needed to understand symptom presentation and development as well as treatment moderators, predictors, and mediators of change. Also, there is a significant knowledge gap regarding how fatigue can be identified and treated in an early phase in the primary care context. Given the similarities in effective treatment protocols across fatigued samples, together with potentially common change mechanisms, investigating the effectiveness of a transdiagnostic treatment protocol is a promising avenue with enormous potential utility to increase clinical effects, accessibility, and large-scale implementation. To date, no transdiagnostic treatment specifically targeting fatigue across patient groups has been evaluated.

The current study:

Based on previous disorder-specific treatment protocols aimed to reduce fatigue severity in various fatigued populations, the investigators have developed a transdiagnostic CBT treatment (tCBT) adapted for primary care patients who suffer from persistent fatigue independent of primary diagnosis. The treatment is delivered in a blended format (face-to-face therapy combined with internet-delivered texts and exercises) and is administrated over 4 - 6 months. The feasibility of tCBT has recently been evaluated in a non-randomized feasibility trial (Clinical trials ID: NCT06341751).

Study design:

The planned study is a randomized clinical superiority trial that will recruit fatigued patients listed at primary healthcare clinics in Region Stockholm. Study participants will be randomized to tCBT or to CAU by a person not related to the study. Due to the nature of the study, blinding to treatment condition will not be possible.

Data collection includes clinician-rated data, self-rated symptom measures, and register-based data using interlinked microdata from regional and national registers. Cognitive functioning will be assessed using a digital cognitive test-battery that will be administered at baseline and at the 12-month follow up. Additionally, the study will explore changes in physiological variables (in a subset of participants) from baseline to the 12-month follow-up using continuous data collected from biometric rings.

Research questions:

RQ1. Is tCBT associated with a greater post-treatment reduction in fatigue severity (primary outcome) and secondary outcome domains (self-rated symptoms, cognitive functioning, net days on sick leave) compared to CAU?

RQ2. What characterizes the fatigued sample at baseline in terms of sociodemographic, clinical, and biometric variables? Can clinically relevant subgroups of patients be identified that share similar characteristics?

RQ3. Which factors moderate and mediate the effect of tCBT vs. CAU and which factors predict symptom development? We hypothesize (1) that there will be transdiagnostic subgroups of patients that differ in treatment response based on baseline characteristics as identified in RQ2, that (2) these characteristics can be used to model treatment outcomes using supervised machine learning, and further that (3) changes in cognitive and behavioral responses to fatigue (e.g., fear avoidance, catastrophizing about symptoms, all-or-nothing behavior) as well as sleep- and physical activity patterns will mediate the effect of tCBT vs. CAU.

RQ4. Are there differences between participants who received tCBT vs. CAU at the 12- and 60-month follow-up and do individual characteristics moderate these differences?

RQ5. Is tCBT vs. CAU a cost-effective treatment at the 12 month follow-up? Indirect (e.g., work absenteeism, sick leave) and direct (e.g., healthcare consumption) costs will be evaluated using data from national registers.

RQ6. Which healthcare interventions are provided for participants who are randomized to CAU, and do sociodemographic, geographic, and clinical factors predict the type and extent of treatment delivered?

Recruitment procedure:

This study will recruit participants directly from primary care clinics in Region Stockholm. Hence, no advertisement in newspapers or in social media will be conducted to target potential study participants. All information about the study, aimed at both study participants and primary care staff, will be made available on a study webpage.

Patients can be referred to the study by their primary care physician if they (a) report at least three months of persistent, functionally disabling fatigue as a central symptom and (b) the general practitioner (GP) has assessed that the fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia, sleep apnea, post-traumatic stress disorder) or a side-effect of medication. See below ("Eligibility") for inklusion/exclusion criteria.

Estimated sample size and power:

When the trial was initially planned, a preliminary power-analysis was conducted based on research investigating the effect of transdiagnostic CBT vs. active control conditions and our assessment of the smallest clinically meaningful difference. With 90% power to detect a standardized effect size of d = 0.25 on the primary outcome fatigue severity, given an alpha of .05, an intraclass correlation between measurements of 0.7, and an expected attrition of 20%, we needed to include 250 participants in each arm (a total sample size of N = 500).

A later Monte Carlo simulation was conducted based on more relevant previous literature and data from the feasibility trial of the current study (see file:///C:/Users/50QZ/Downloads/power_analysis_report.html). This analysis recommended a sample size of 95 participants per group (190 total), ensuring a 90% power to detect an effect size of Cohen's d=0.6 on the primary outcome.

Statistical methods:

Analyses will be based on an intention-to-treat approach. Change in the primary outcome measure will be analyzed using mixed effects linear regression. Change from baseline to treatment completion (6 months post baseline) will be the primary endpoint. Fixed predictors in these analyses will be time, group and their interaction effect while taking individual variation in baseline symptom levels and change over time into account (i.e., random intercept and/or slope).

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Gustavsberg
      • Stockholm, Gustavsberg, Sweden, 134 40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age 18-67
  2. enrollment at a primary care clinic in Region Stockholm
  3. severe, functionally disabling fatigue as a central symptom for at least 3 months
  4. The fatigue has an identifiable start and hence has not been life-long;
  5. The fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia) or the effect of medication
  6. regular access to a computer and to the Internet
  7. ability to read and write in Swedish.
  8. ability to visit a study center for participation in potential assessments and treatment sessions (maximum 60 minutes) and to take part of written material via the internet.

Exclusion Criteria:

  1. substance abuse disorder in the past 6 months
  2. Current or past psychosis or bipolar disorder
  3. Primary psychiatric disorder of such severity that it merits evidence-based treatment (e.g., obsessive compulsive disorder, moderate to severe depression, post-traumatic stress disorder, anorexia nervosa)
  4. elevated risk for suicide
  5. deliberate self harm in the past 6-months (e.g., cutting, burning, poisoning);
  6. BMI>40
  7. Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month
  8. ongoing chemotherapy
  9. intellectual disability (e.g., severe autism) that affects ability to work with the treatment
  10. pregnancy
  11. life circumstances that complicate or make treatment impossible (e.g., domestic violence, ongoing legal disputes, disputes with social insurance agency, planed or on-going work capacity assesment regarding permanent work disability pension or planed surgery)
  12. ongoing psychological treatment and/or multimodal rehabilitation.
  13. working night shifts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavioral therapy for persistent fatigue
The treatment consists of three main phases: 1) goal-setting; stabilizing sleep-wake patterns and even distribution of activities over the day (pacing). Attention-shifting and cognitive reappraisal 2. Gradual increase in physical activity followed by gradual increase in mental and social activity 3. Gradual steps to reach individual goals.

The treatment is based on a treatment manual that has previously been evaluated in several randomized controlled trials for persistently fatigued patients with various types of chronic somatic disorders (primarily in specialized healthcare settings).

In this trial we have translated the treatment manual to Swedish and adopted it for implementation in a Swedish primary care setting. The treatment format is "blended", meaning that the treatment is administered both via an online platform (where the participant can communicate with the therapist through asynchronous text-messages) and via face-to-face therapy sessions with the therapist.

Other Names:
  • tCBT
Other: Care as usual (CAU)
Since there are no standardized, structured care programs and guidelines for the patient group, CAU may include a broad variety of psychosocial support, psychological treatment, physiotherapy, occupational therapy, pharmacological treatment, follow-up within specialist healthcare, and/or follow-up by general practitioners. An important aim of the project is to carefully map the content and scope of the care offered to patients in the study within the framework of CAU.
Since there are no standardized, structured care programs and guidelines for the patient group, CAU may include a broad variety of psychosocial support, psychological treatment, physiotherapy, occupational therapy, pharmacological treatment, follow-up within specialist healthcare, and/or follow-up by general practitioners. An important aim of the project is to carefully map the content and scope of the care offered to patients in the study within the framework of CAU.
Other Names:
  • CAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rated fatigue severity
Time Frame: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline))
Fatigue severity (self-rated) using the Checklist Individual Strengths - Fatigue severity subscale (CIS-F). The domain Fatigue severity contains 8 items scored on a 7-point Likert scale (range 8-56; higher scores=more severe fatigue).
Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline))

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration
Time Frame: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Concentration is a subscale in the Checklist Individual Strengths (CIS). The subscale contains 5 items scored on a 7-point Likert scale. Higher ratings indicate more problems with concentration.
Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Motivation
Time Frame: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Motivation is a subscale in the Checklist Individual Strengths (CIS). The subscale contains 4 items scored on a 7-point Likert scale. Higher ratings indicate more difficulties with motivation.
Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Activity
Time Frame: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Activity is a subscale in the Checklist Individual Strengths (CIS). The subscale contains 3 items scored on a 7-point Likert scale. Higher ratings indicate reduced activity.
Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Self-rated depressive symptoms
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months). Suicide-item will be administered every three weeks during the treatment phase.
Patient Health Questionnaire-9 (PHQ-9). Scale range is from 0 to 27, higher scores representing more depressive symptoms. NOTE: The suicide-item will be administered every three weeks during the treatment phase).
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months). Suicide-item will be administered every three weeks during the treatment phase.
Somatic symptoms
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
Physical Health Questionnaire-15 (PHQ-15). Scale range is from 0 to 30, higher scores representing more somatic symptoms
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
General anxiety
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
The General Anxiety Questionnaire (GAD-7). Scale range is from 0 to 21, higher scores representing more anxiety.
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
Insomnia Severity
Time Frame: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)

The Insomnia Severity Inventory (ISI) 7 items. Scale range is from 0 to 28, higher scores representing higher insomnia severity.

An additional item will be added to assess hypersomnia.

Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Perceived Stress
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
The Perceived Stress Scale (PSS-10). Scale range is from 0 to 40, higher scores representing a higher level of perceived stress.
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
Burnout
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
The Shirom-Melamed Burnout Questionnaire (SMBQ-18). Scale range is from 0 to 6, higher scores representing a higher level of burnout.
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
Self-rated health
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
The Self-rated health questionnaire (SRH-5). A single item with 5 response-categories, 0 (very bad health); 4 (very good health)
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
Cognitive and behavioral responses to symptoms
Time Frame: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Process measure: Cognitive and behavioral responses to symptoms questionnaire (CBRQ), 18-items. The scale assesses six domains: Fear avoidance (3 items, scale range 0-12); Damage beliefs (3 items, scale range 0-12); Embarrassment avoidance (3 items, scale range 0-12); Symptom focusing (3 items, scale range 0-12); All-or-nothing behaviour (3 items, scale range 0-12); Resting behaviour (3 items, scale range 0-12).
Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
General self-efficacy
Time Frame: Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Process measure: The General self-efficacy scale (GSE), 10 items. Scale range is from 10 to 40, higher scores representing a higher level of self-efficacy.
Baseline (Pre intervention), during treatment phase (every three weeks), post (6 months after baseline) and long term follow up (12 months after baseline)
Functional disability
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12 items. Scoring from 0 (maximum functional disability) to 100 (no functional disability)
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
Work and Social Adjustment
Time Frame: Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
The Work and Social Adjustment Scale (WSAS), 5 items. Scale range 0 to 40 with higher scores representing better work and social adjustment.
Baseline (Pre treatment), Post treatment (6 months), long-term follow-up (12 months).
Self-rated exhaustion disorder (s-UMS)
Time Frame: Baseline, post treatment (6 months) and 12-month follow-up from baseline.
s-UMS is a questionnaire developed for self-assessment of diagnostic criteria for exhaustion disorder. Eight diagnostic items are responded to as "yes" or "no". The last item pertains to consequences and functional disability and is responded to on a scale of 0 (no functional disability), 1 (yes, some functional disability), or 2 (yes, significant functional disability).
Baseline, post treatment (6 months) and 12-month follow-up from baseline.
Symptoms of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Time Frame: Baseline, post treatment (6 months) and 12-month follow-up from baseline.

A 25-item self-rated symptom questionnaire in which respondents first respond yes/no to each symptom and then in a second step, if "Yes", respond to the severity level of that symptom on a scale from 1-4 ("mild", "moderate", "severe", "very severe").

Scores of symptom severity are added for a scale range of 1-100 (higher scores indicate higher symptom severity).

Baseline, post treatment (6 months) and 12-month follow-up from baseline.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment credibility
Time Frame: Three weeks after treatment start
Assessed using the Credibility/Expectancy Questionnaire (C-Scale). The C-Scale is a 5-item measure, scale range is 0 to 50 points with higher scores indicating higher treatment credibility.
Three weeks after treatment start
Patient satisfaction with treatment/healthcare
Time Frame: Post-treatment (6 months)

Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater treatment satisfaction.

A slightly revised version will be administered to participants in the CAU group to probe satisfaction with healthcare.

Post-treatment (6 months)
Negative effects of treatment
Time Frame: Post treatment (6 months from baseline)

The Negative Effects of Treatment Questionnaire (NEQ-20). The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (dummy coded as a variable: 1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely", 0-4 ("0" being minimum and "4" being maximum). Third, the respondents attribute the negative effect to "The treatment I received" (1) or "Other circumstances" (0) (dummy coded as a variable: 1/0).

A slightly revised version will be administered to participants in the CAU group to probe negative effects of healthcare.

Post treatment (6 months from baseline)
Adverse events related to study participation/treatment
Time Frame: weeks 6, 12, 18
Open-ended questions regarding potential adverse events will be administered to study participants in both treatment arm every 6 weeks during the treatment phase.
weeks 6, 12, 18
Cognitive functioning
Time Frame: Baseline and 12-month follow-up from baseline
Will be assessed using a validated digital cognitive test battery. The test will assess attention and processing speed, executive functioning, and memory. The total test takes approximately 25 minutes to complete.
Baseline and 12-month follow-up from baseline
Healthcare consumption
Time Frame: Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Data will be collected from Region Stockholm's database (VAL) that provides information about all publicly funded outpatient and inpatient healthcare provided in Stockholm County, including number of healthcare visits.
Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Sickness absence
Time Frame: Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Data on sickness benefits as well as sickness and activity compensation will be retrieved from the Swedish Social Insurance Agency's database (MiDAS).
Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Individual-level socioeconomic information
Time Frame: Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Data will be retrieved from Statistics Sweden's LISA database (Longitudinal Integration Database for Health Insurance and Labour Market Studies) and include information about occupation and type of income and benefits.
Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Medication use
Time Frame: Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.

Registry data: National Board of Health and Welfares registry

From the Prescribed Drug Register: Dispensed prescribed medications (ATC codes, dates, DDD).

Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Cause of death
Time Frame: Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.

Registry data: National Board of Health and Welfares registry

From the Cause of Death register: (1) date of death and (2) causes of mortality.

Data will be collected from two years before inclusion in the study up to 60 months after inclusion, meaning from 2023-2030.
Heart rate variability
Time Frame: Continuous data-collection from baseline to 12-month follow-up.
A subset of participants will receive a non-invasive biometric ring (worn on participant finger) to collect data on heart rate variability from baseline to the 12-month follow up.
Continuous data-collection from baseline to 12-month follow-up.
Sleep- and activity patterns
Time Frame: Continuous data-collection from baseline to 12-month follow-up.
A subset of participants will receive a non-invasive biometric ring (worn on participant finger) to collect data on movement and sleep from baseline to the 12-month follow up.
Continuous data-collection from baseline to 12-month follow-up.
Body temperature fluctuations
Time Frame: Continuous data-collection from baseline to 12-month follow-up.
A subset of participants will receive a non-invasive biometric ring (worn on participant finger) to collect data on fluctuations in body temperature from baseline to the 12-month follow up.
Continuous data-collection from baseline to 12-month follow-up.
Working alliance
Time Frame: Week 3 and 15 of treatment
Assessed using the Working Alliance Questionnaire (WAI - short version). Scale range is from 6 to 42 with higher scores indicating a better percieved working alliance. Will only be administered to the exerimental treatment arm (iFAS)
Week 3 and 15 of treatment
Alcohol Use
Time Frame: Pre inclusion screening only
AUDIT (Alcohol Use Disorders Identification Test) is used for screening for unhealthy alcohol use, defined as risky or hazardous consumption or any alcohol use disorder. It identifies alcohol intake, potential dependence on alcohol and, experience of alcohol-related harm.
Pre inclusion screening only
Symptoms of autism
Time Frame: Pre inclusion screening only.
The Ritvo Autism and Asperger Diagnostic Scale-Revised (RAADS-14) is a diagnostic tool specifically designed to assist in the identification of autism spectrum disorder (ASD) in adults. The scale ranges from 0-42 and covers three areas: Mentalizing deficits, Social anxiety and Sensory reactivity.
Pre inclusion screening only.
Symptoms of adhd in childhood
Time Frame: Pre inclusion screening only
The Wender Utah Rating Scale - 25 item version (WURS-25) is a self-report instrument that is designed to retrospectively evaluate the presence and severity of childhood symptoms of ADHD in adults in the following areas: Impulsivity and Behavioural problems, Inattentiveness and School problems, Self Esteem and Negative mood. Scale ranges from 0-100 with scores above 36 indicating high likelihood of ahdh.
Pre inclusion screening only
Hypermobility
Time Frame: Pre inclusion screening only
The self-assessment five-part questionnaire on hypermobility (5PQ) consists of five items rated "Yes" or "No", with two or more "Yes" answers indicating generalised joint hypermobility.
Pre inclusion screening only
Comorbidity (self-registered)
Time Frame: Pre inclusion screening only
A list of 34 common somatic and psychiatric diagnosis known as the "Comorbidity table" was used. For each specific diagnosis the answers given are "No, never", "Yes, previous", and "Yes, ongoing".
Pre inclusion screening only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elin Lindsäter, PhD, Ass. Prof, Region Stockholm and Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2033

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Cognitive behavioral therapy for persistent fatigue

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