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BurnoutNCT07272421

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

A study testing ACT, Recuperation and Vocational support in people with Burnout and Clinical Burnout, run by Uppsala University at 1 site in Sweden.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burnout, Clinical Burnout, Exhaustion Disorder
What is being tested?
ACT, Recuperation and Vocational support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteSweden
Study dates
1 Dec 2025to 31 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age 18 years or older
  • Self-reported or clinically verified symptoms consistent with clinical burnout (e.g., pronounced fatigue, cognitive difficulties, and reduced stress tolerance following prolonged psychosocial stress)
  • Currently on ≥25% sick leave and experiencing significant functional impairment in work or daily life due to these symptoms
  • Stable occupation or engagement (employment or studies)
  • Ability to read and write Swedish
  • Daily access to the internet

Who cannot join

  • Sick leave > 2 years for the current episode
  • Severe acute psychiatric conditions, including: severe depression, bipolar disorder, untreated PTSD, schizophrenia, or other psychotic disorders
  • Current substance abuse
  • Active suicidal ideation (as assessed during clinical evaluation)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jakob Clason van de Leur, PhD contact

018-471 6802 ext. +46

jakob.clason-vandeleur@psyk.uu.se

Sweden1 site, 1 recruiting
  • Instution of Psychology (online)

    Uppsala, Uppsala County, 752 37

    Jakob Clason van de Leur, PhD, +4618-471 6802, jakob.clason-vandeleur@psyk.uu.se

    Recruiting

Other trials in Sweden

About this study

Official title: A Three-Arm Randomized Controlled Trial Comparing Online 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, ca 400 adults in Sweden with clinical burnout will be randomly assigned to one of three 10-week, internet-based treatments:

Read more

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.

Read the detailed description

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 ca 400 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. In addition, clinicians will provide prognostic ratings of expected symptom improvement and work participation outcomes at post-treatment and 12-month follow-up.

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.

Being tested
ACT, Recuperation, Vocational support
Keywords
ACT, Online, Burnout, Return To Work, Recovery
Medical subject headings
Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTBehavioural

    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.

  • RecuperationBehavioural

    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.

  • Vocational supportBehavioural

    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.

Study groups in NCT07272421
Study groupRoleWhat they receive
Arm 1: ACTExperimentalA 10-week online ACT program focusing on psychological flexibility, value clarification, and exposure to behaviors that maintain exhaustion (e.g., avoidance, perfectionism, rigid rules). Participants complete weekly digital modules with therapist guidance via written feedback and three brief video sessions.
Receives: Behavioral: ACT
Arm 2: RecuperationActive comparatorA 10-week online program emphasizing rest, recuperation, and healthy daily routines. Content includes psychoeducation, sleep hygiene, pacing, relaxation, and gentle physical activity, without ACT-specific components. Participants complete weekly modules with therapist support through written feedback and three brief video sessions.
Receives: Behavioral: Recuperation
Arm 3: ACT + vocational supportActive comparatorA 10-week online ACT program combined with three additional sessions focused on work-related barriers and return-to-work planning. Participants receive weekly ACT modules with therapist guidance, three standard video sessions, and three vocational sessions delivered by licensed psychologists to create a structured, individualized RTW plan.
Receives: Behavioral: ACT; Behavioral: Vocational support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 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)

  2. 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)

    Measured: From post-treatment (Week 10) to 12-month follow-up (Month 12 post-treatment)

Secondary outcomes (8)
  1. 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)

    Measured: 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)

  2. 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)

    Measured: 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)

  3. 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)

    Measured: 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)

  4. 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

    Measured: 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)

  5. 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)

    Measured: 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)

  6. 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)

    Measured: Post-treatment (Week 10)

  7. 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).

    Measured: Post-treatment (Week 10)

  8. 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
This is a three-arm, parallel-group, randomized controlled superiority trial evaluating three distinct 10-week psychological interventions for adults with clinical burnout. Participants are randomized in a 1:1:1 allocation ratio to: 1. online Acceptance and Commitment Therapy (ACT), 2. an online recuperation-focused program, or 3. online ACT combined with structured vocational support.
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07272421
Sponsor's protocol ID
2025-05666-01
Other IDs
2025
Status last verified
Oct 2026
First submitted
17 Nov 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified participant data for all reported outcomes will be shared upon reasonable request after publication. Access will be granted to qualified researchers who provide a methodologically sound proposal and sign a data-sharing agreement. Data will be transferred through a secure repository in accordance with GDPR requirements.

Questions about this trial

What is this clinical trial studying?

A study testing ACT, Recuperation and Vocational support in people with Burnout and Clinical Burnout, run by Uppsala University 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 4 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jakob Clason van de Leur, PhD (018-471 6802 ext. +46, jakob.clason-vandeleur@psyk.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burnout Symptom Severity (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)). 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 16 Oct 2026.

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