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.
Clinical burnout (also referred to as stress-related exhaustion) is a common reason for long-term sick leave in Sweden. Although many patients receive psychological or rehabilitative support, there is currently no established evidence-based treatment for clinical burnout, and the theoretical models guiding clinical care vary widely. Two dominant approaches in current practice are (1) recuperation-focused interventions emphasizing rest, balance, and lifestyle change, and (2) cognitive-behavioral approaches that aim to modify patterns of behavior and internal experience. Return-to-work (RTW) support is also widely regarded as important, yet structured, scalable, and well-defined RTW models tailored for burnout remain scarce. This randomized controlled trial evaluates three 10-week online treatments for adults with clinical burnout: 1. Online Acceptance and Commitment Therapy (ACT) ACT is a contextual behavioral approach that aims to increase psychological flexibility-defined as the capacity to act in accordance with one's values while remaining open to difficult internal experiences. The intervention uses value clarification, behavior change strategies, mindfulness exercises, and structured exposure to behaviors that maintain exhaustion (e.g., avoidance, perfectionism, rigid rules around rest and activity). The program frames burnout as a crisis of engagement driven by excessive "musts" and "shoulds," helping participants reconnect with personally meaningful activities. 2. Online Recuperation-Focused Treatment This comparator is an active, credible intervention resembling what many patients receive in Swedish primary care. It focuses on rest, variation, energy monitoring, sleep hygiene, pacing, relaxation exercises, and general stress management. The treatment is primarily supportive and non-directive, emphasizing recuperation rather than behavioral exposure or value-guided change. 3. Online ACT plus Vocational Support This condition combines the ACT program with three additional sessions conducted by licensed psychologists focusing on work-related functioning. These sessions guide participants in mapping barriers to work participation, identifying feasible adjustments, and creating a written long-term RTW plan that can be shared with employers and treating physicians. This component is intended to support coordinated and gradual work reintegration. Study Rationale Existing interventions for clinical burnout are often broad, multimodal, and resource-intensive. They may rely heavily on rest-based strategies and physiologically oriented explanations that risk reinforcing avoidance and passivity. ACT offers a theoretically coherent alternative that emphasizes behavioral re-engagement, values-based action, and psychological flexibility, which may be particularly relevant in burnout characterized by disengagement and rigid coping patterns. At the same time, many patients with burnout struggle to return to work, and early coordination between the individual, employer, and health care system is often lacking. Integrating structured vocational support into an ACT treatment may help translate behavioral gains into improved work functioning. Study Design This is a three-arm, parallel-group, randomized controlled superiority trial with a 1:1:1 allocation ratio. A total of 210 participants will be recruited across Sweden and randomized to one of the three interventions. Treatments are delivered over 10 weeks via the secure digital platform BASS. Each treatment includes 10 self-guided online modules, therapist feedback via weekly written chat, and three scheduled video sessions. The ACT + Vocational arm includes three additional vocational sessions. All assessments, consent procedures, and follow-ups are conducted online. Registry data on sick leave will be obtained from the Swedish Social Insurance Agency for the 12 months following treatment, allowing for objective evaluation of long-term functional recovery. Assessments occur at baseline, weekly during treatment (selected measures), mid-treatment, post-treatment, and at 6- and 12-month follow-up. Intervention Delivery and Therapist Training Therapists in the ACT and Recuperation conditions are clinical psychology students in their final semester who have completed training in CBT. Licensed psychologists with experience in rehabilitation deliver the ACT + Vocational condition. All therapists receive structured protocols, two days of training, and weekly supervision to ensure consistent delivery and fidelity across conditions. Primary Objectives Symptom reduction Evaluate whether ACT produces greater improvements in self-rated burnout symptoms than a recuperation-focused treatment at post-treatment and at follow-up. Return-to-work outcomes Determine whether adding structured vocational support to ACT reduces the number of registered net sick-leave days during the 12 months after treatment. Secondary and Exploratory Objectives Secondary objectives include comparing treatments on perceived stress, depression, anxiety, insomnia, everyday memory problems, quality of life, functional impairment, treatment adherence, treatment response and remission, and adverse effects. Process outcomes (e.g., psychological flexibility, recuperation behaviors, RTW self-efficacy) will also be assessed to examine change processes. Economic evaluations will estimate cost-effectiveness from healthcare and societal perspectives. A qualitative sub-study will explore participants' experiences of ACT and, to a smaller extent, the other treatment arms. Statistical Overview Repeated self-report outcomes will be analyzed using linear mixed-effects models with fixed effects for group, time, and group × time interactions, and random effects for participants. Sick-leave outcomes will be analyzed using negative binomial or Poisson regression models. All primary analyses will follow the intention-to-treat principle. Sensitivity, adjusted, and missing-data analyses (including multiple imputation) are planned. The study is powered to detect small-to-moderate between-group effects on symptom trajectories and medium-sized differences in sick leave. Data Monitoring and Safety Given the low-risk, non-pharmacological nature of the interventions, no independent data monitoring committee is established. Participants are monitored weekly, including automated alerts for worsening symptoms. Emergent risk (e.g., suicidal ideation) triggers same-day assessment by a licensed psychologist. Adverse events will be recorded systematically during and after treatment. Expected Contributions This study directly compares two theoretically distinct treatment models for clinical burnout and evaluates whether structured vocational support enhances functional recovery. It is among the first trials to assess an integrated, scalable ACT-based model for clinical burnout delivered entirely online. Findings may help identify effective strategies for reducing symptoms, supporting return to work, and informing the development of future evidence-based guidelines for clinical burnout.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
The ACT intervention targets psychological flexibility using value clarification, functional analysis of stress-maintaining behaviors, mindfulness exercises, and structured exposure to avoidance, perfectionism, and rigid behavioral patterns associated with clinical burnout. The treatment content emphasizes reconnecting with personal values, increasing engagement in meaningful activities, and reducing ineffective coping strategies, such as excessive rest, overcontrol, and avoidance of work-related or emotionally difficult situations.
The recuperation intervention emphasizes restoring balance through rest, energy management, and healthy daily routines. Core content includes psychoeducation about stress and recovery, sleep hygiene, relaxation and breathing exercises, pacing strategies, gentle physical activity, and establishing structured routines for variation and recuperation. The treatment focuses on supporting restorative habits and reducing overload without using exposure, values work, or other ACT-specific methods.
The vocational support component provides structured guidance to identify work-related barriers, clarify functional limitations, and develop a realistic, individualized return-to-work (RTW) plan. Content includes mapping job demands, exploring feasible work adjustments, formulating stepwise RTW goals, and identifying supports needed from the employer. Sessions focus on helping the participant create a written RTW plan that can be shared with relevant stakeholders.
Burnout Symptom Severity
This is one of two co-primary outcomes. Burnout symptoms will be assessed using the Shirom-Melamed Burnout Measure-12 (SMBM-12), a 12-item self-report scale measuring the core components of burnout: emotional and physical exhaustion (items 1-6) and cognitive/mental exhaustion (items 7-12). Each item is rated from 1 (almost never) to 7 (almost always). Items are averaged to produce a total mean score ranging from 1 (lowest level of burnout) to 7 (highest level of burnout). Higher scores indicate more severe burnout symptoms. Only the total mean score will be used as the primary outcome. Unit of Measure: SMBM-12 mean total score (1-7)
Time frame: Baseline (Week 0); weekly assessments during treatment (Weeks 1-10); mid-treatment (Week 5); post-treatment (Week 10, primary endpoint); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
Net Sick-Leave Days
This is one of two co-primary outcomes. This outcome reflects the total number of registered sick-leave days during the 12-month period following treatment. Data will be obtained from the Swedish Social Insurance Agency. Part-time sick leave will be converted into net days (e.g., 50% sick leave = 0.5 net day). Higher values indicate worse functional outcome (i.e., more days of sick leave). Unit of Measure: Net sick-leave days (0 to no upper limit)
Time frame: From post-treatment (Week 10) to 12-month follow-up (Month 12 post-treatment)
Perceived Stress
Perceived stress will be measured using the Perceived Stress Scale-10 (PSS-10), a 10-item self-report questionnaire assessing the degree to which situations in one's life are appraised as stressful. Items are rated on a 0-4 scale and summed to a total score ranging from 0 (lowest perceived stress) to 40 (highest perceived stress). Higher scores indicate greater perceived stress.
Time frame: Baseline (Week 0); weekly assessments during treatment (Weeks 1-10); mid-treatment (Week 5); post-treatment (Week 10, primary endpoint); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
Anxiety Symptoms Severity
Anxiety severity will be measured using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire. Each item is rated from 0 (not at all) to 3 (nearly every day). Items are summed to produce a total score ranging from 0 (no anxiety) to 21 (severe anxiety). Higher scores indicate greater anxiety severity. Unit of Measure: GAD-7 total score (0-21)
Time frame: Baseline (Week 0); mid-treatment (Week 5); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
Depressive symptoms severity
Depressive Symptom Severity will be measured using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale. Each item is rated from 0 (not at all) to 3 (nearly every day). Items are summed to produce a total score ranging from 0 (no depressive symptoms) to 27 (severe depressive symptoms). Higher scores indicate greater depressive symptom severity. Unit of Measure: PHQ-9 total score (0-27)
Time frame: Baseline (Week 0); mid-treatment (Week 5); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
Insomnia severity
Sleep disturbance will be measured using the Insomnia Severity Index (ISI), a 7-item self-report scale assessing the severity and impact of insomnia symptoms. Each item is rated on a 0-4 scale, with response options reflecting increasing severity (e.g., from "no problem" to "very severe problem"). Item scores are summed to produce a total score ranging from 0 (no insomnia) to 28 (severe insomnia). Higher scores indicate greater sleep disturbance. Unit of Measure: ISI total score (0-28)
Time frame: Baseline (Week 0); mid-treatment (Week 5); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
Health-Related Quality of Life
Health-related quality of life will be measured using the EQ-5D-5L, which assesses five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-level scale from 1 (no problems) to 5 (extreme problems). Responses are converted into a single index value based on the Swedish value set, ranging from values below 0 (states worse than death) to 1 (full health). Higher values indicate better health-related quality of life. Unit of Measure: EQ-5D-5L index value
Time frame: Baseline (Week 0); mid-treatment (Week 5); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
Overall Quality of Life
Quality of life will be measured using the Brunnsviken Brief Quality of Life Inventory (BBQ), which includes six life domains, each represented by a pair of items assessing importance and satisfaction. For each domain, the satisfaction rating is multiplied by the corresponding importance rating, producing a domain score ranging from 0 to 16. The total BBQ score is the sum of all weighted domain scores and ranges from 0 (lowest quality of life) to 96 (highest quality of life). Higher scores indicate better overall quality of life. Unit of Measure: BBQ weighted total score (0-96)
Time frame: Baseline (Week 0); mid-treatment (Week 5); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
Treatment Satisfaction
Treatment satisfaction will be measured using the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item self-report scale assessing satisfaction with received treatment. Each item is rated from 1 to 4, with response anchors varying by item; however, in all items 1 reflects low satisfaction and 4 reflects high satisfaction. Item scores are summed to produce a total score ranging from 8 (lowest satisfaction) to 32 (highest satisfaction). Higher scores indicate greater treatment satisfaction. Unit of Measure: CSQ-8 total score (8-32)
Time frame: Post-treatment (Week 10)
Negative effects of Treatment
Potential adverse or unwanted effects of treatment will be assessed using the Negative Effects Questionnaire-20 (NEQ-20), a 20-item self-report measure. The NEQ-20 consists of five subscales, each scored by summing the items within the domain: Symptoms: items 1, 2, 3, 4, 6, 7, 8, 10 Quality: items 15, 16, 17, 18, 19, 20 Dependency: item 14 Stigma: items 9, 11 Hopelessness: items 5, 12, 13 Subscale scores are summed to produce a total score, with higher scores indicating a greater number or severity of negative effects. Response formats vary by item (e.g., presence, severity, or attribution). Unit of Measure: NEQ-20 total and subscale scores (higher = more negative effects).
Time frame: Post-treatment (Week 10)
Healthcare Utilization and Costs
Healthcare utilization, productivity loss, and associated costs will be measured using the Trimbos and Institute of Medical Technology Cost Questionnaire for Psychiatry (TiC-P). The TiC-P assesses contacts with healthcare providers, medication use, informal care, and sickness absence/productivity loss. Cost categories will be calculated according to TiC-P scoring guidelines. Higher values reflect greater healthcare use or higher associated costs, depending on the component analyzed. Unit of Measure: TiC-P cost and utilization metrics
Time frame: Baseline (Week 0); mid-treatment (Week 5); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)
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