Clinical Research Directory

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

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.

Step by Step Back - A Feasibility Study of a Physical Activity Intervention for Adults With Stress-related Exhaustion

The goal of this clinical study is to learn whether a psychologist- or psychotherapist-guided physical activity program can be delivered and used as part of regular care for adults experiencing stress-related exhaustion. The program is designed to be integrated into regular psychological treatment as usual and supports participants in developing physical activity habits in a gradual, individualized, and sustainable way. The main questions this study aims to answer are: * Can participants complete the program and attend the planned sessions? * Do participants and clinicians find the program acceptable, relevant, and useful? * Is the program safe, and do any negative experiences occur during the program? * What practical barriers and facilitators affect participation and delivery in routine care? * What descriptive patterns of change are seen in physical activity, symptoms, and everyday functioning from before to after the program? The program is based on cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). It includes strategies to help participants set meaningful goals, take step-by-step actions toward those goals, and respond more flexibly to uncomfortable thoughts, emotions, and body sensations that may arise in relation to physical activity. About 12 to 20 participants will take part. The program is designed to be integrated into about 5 to 6 individual sessions delivered over a flexible time period, depending on each participant's pace and circumstances. Participants will: * Take part in the physical activity program as part of their regular psychological treatment * Complete online questionnaires before and after the program * Log their physical activity during the program * Provide feedback after the program (and some participants will also take part in an interview) The results will be used to assess whether the program is feasible and acceptable for participants and clinicians and to inform further refinement and future evaluation.

Comparing ACT, Recuperation, and ACT Plus Vocational Support for Clinical Burnout

This study compares three different online psychological treatments for people with clinical burnout (stress-related exhaustion) who are on sick leave or have major difficulties coping at work or in daily life. Many patients with burnout receive broad, recuperation-focused interventions (rest, stress reduction, lifestyle changes), but there is still no clearly evidence-based treatment or agreed clinical model. It is also known that returning to work can be difficult, and there is a need for more structured support. In this trial, 210 adults in Sweden with clinical burnout will be randomly assigned to one of three 10-week, internet-based treatments: Online Acceptance and Commitment Therapy (ACT) A structured, values-based CBT approach that focuses on helping participants clarify what matters to them, relate differently to difficult thoughts and feelings, and gradually re-engage in meaningful activities despite exhaustion. Online Recuperation-focused treatment An active comparison condition that emphasizes rest, recuperation, and healthy daily routines. It provides psychoeducation and practical tools for sleep, relaxation, physical activity, pacing, and balance in everyday life, but does not include ACT-specific methods such as exposure or values work. Online ACT plus Vocational Support The same ACT program as in group 1, together with three additional sessions with a licensed psychologist focused on work. These sessions help the participant identify work-related barriers, plan a gradual return-to-work (RTW), and formulate a written RTW plan that can be shared with the employer and treating physician. All three treatments are delivered via a secure digital platform. Participants work through weekly online modules, receive written feedback from a therapist, and have three video sessions during the 10-week period. Clinical psychology students in their final semester deliver the ACT and recuperation treatments, and licensed psychologists deliver the ACT + vocational support condition. The study has two primary aims: 1. to test whether online ACT reduces self-rated burnout symptoms more than the recuperation-focused treatment at the end of treatment, and 2. to test whether adding structured vocational support to ACT reduces the total number of registered sick-leave days in the year after treatment, compared with ACT alone. Key secondary outcomes include perceived stress, depression, anxiety, insomnia, everyday memory problems, quality of life, functional impairment, treatment response and remission, treatment credibility and satisfaction, and cost-effectiveness. Outcomes are measured before treatment, weekly during treatment (for selected measures), immediately after treatment, and at 6- and 12-month follow-ups. Sick-leave data are obtained from the Swedish Social Insurance Agency. To be eligible, participants must be 18 years or older, have symptoms consistent with clinical burnout (including pronounced fatigue and reduced stress tolerance after prolonged psychosocial stress), be on at least 25% sick leave or have marked functional impairment due to these symptoms, have a stable occupation or study situation, and be able to read and write Swedish. People with very long sick leave (more than two years), severe psychiatric conditions (such as severe depression, bipolar disorder, untreated PTSD, or psychosis), current substance abuse, or active suicidal ideation will not be included. Potential risks include temporary increases in distress, fatigue, or symptom awareness when working with emotions, behavior change, or work-related issues. Participants are monitored closely through weekly questionnaires and therapist contact. If risk for self-harm or serious deterioration is detected, a licensed psychologist will perform a risk assessment and, if needed, refer the participant to appropriate health care. The hope is that this study will identify effective, scalable, and theory-based online treatments for clinical burnout and clarify whether adding structured vocational support improves long-term work outcomes.

Returning to Work After Stress-Related Sick Leave: An Effectiveness Trial of Work-Focused Treatments in Primary Care

The goal of this clinical trial is to learn if work-focused cognitive behaviour (WCBT) works to treat patients on sick leave due to non-traumatic long-term stress-related disorders. The main questions it aims to answer are: * Is WCBT more effective in improving work ability compared to standard care? * Do participants in WCBT have less sick leave days than those in standard care? * Is WCBT more effective in improving health outcomes and function than standard care? * Is WCBT a more cost-effective treatment option than standard care? Researchers will compare WCBT to standad care to see if there are differences in effect. Participants will participate in: * WCBT * Standard care