iFASTransdiagnostic Fatigue Treatment for Primary Care Patients
Cognitive behavioral therapy for persistent fatigue
+ Care as usual
Burnout, Psychological+4
+ Behavior
+ Behavioral Symptoms
Treatment Study
Summary
Study start date: February 6, 2025
Actual date on which the first participant was enrolled.This clinical trial focuses on understanding and treating fatigue, a condition characterized by extreme and persistent tiredness or exhaustion. Fatigue is a common complaint among 20-30% of patients in primary care, with up to 10% presenting it as their main issue. Despite its high prevalence, the causes of fatigue remain largely unknown. Recent research suggests that factors not attributable to a specific medical condition, such as demographic and psychosocial variables, may better explain fatigue severity. This study aims to evaluate a transdiagnostic cognitive behavioral therapy (tCBT) adapted for primary care patients suffering from persistent fatigue, independent of their primary diagnosis. Participants in this study will be recruited from primary healthcare clinics in Region Stockholm and randomly assigned to either the tCBT group or the care as usual (CAU) group. The tCBT treatment is delivered in a blended format, combining face-to-face therapy with internet-delivered texts and exercises, over a period of 4 - 6 months. The study will measure fatigue severity as the primary outcome, using the Checklist Individual Strengths - Fatigue severity subscale (CIS-F). Secondary outcomes include self-rated symptoms, cognitive functioning, and net days on sick leave. Data collection includes clinician-rated data, self-rated symptom measures, and register-based data. Cognitive functioning will be assessed using a digital cognitive test-battery at baseline and at the 12-month follow up. Additionally, changes in physiological variables will be explored in a subset of participants from baseline to the 12-month follow-up using continuous data collected from biometric rings.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.190 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 67 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Gustavsberg University Primary Care Clinic
Stockholm, SwedenOpen Gustavsberg University Primary Care Clinic in Google Maps