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

NCT07272421 | Not Yet Recruiting

• 1 other identifier: 2025-05666-01
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 1.to test whether online ACT reduces self-rated burnout symptoms more than the recuperation-focused treatment at the end of treatment, and
2. 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.

Conditions

Burnout; Clinical Burnout; Exhaustion Disorder

Keywords

ACT; Online; Burnout; Return To Work; Recovery

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

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

Secondary Outcomes (9)

• Perceived Stress

  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

  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

  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

  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

  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)

Other Outcomes (4)

• Treatment Credibility and Expectancy

  Week 1; mid-treatment (Week 5)

• Psychological Flexibility

  Baseline (Week 0); weekly during treatment (Weeks 1-10); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)

• Recuperation Behaviors

  Baseline (Week 0); weekly during treatment (Weeks 1-10); post-treatment (Week 10); 6-month follow-up (Month 6 post-treatment); 12-month follow-up (Month 12 post-treatment)

Study Arms (3)

Arm 1: ACT

EXPERIMENTAL

A 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.

Behavioral: ACT

Arm 2: Recuperation

ACTIVE COMPARATOR

A 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.

Behavioral: Recuperation

Arm 3: ACT + vocational support

ACTIVE COMPARATOR

A 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.

Behavioral: ACT; Behavioral: Vocational support

Interventions

ACT BEHAVIORAL

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.

Arm 1: ACT; Arm 3: ACT + vocational support

Recuperation BEHAVIORAL

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.

Arm 2: Recuperation

Vocational support BEHAVIORAL

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.

Arm 3: ACT + vocational support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uppsala University: lead

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Jakob Clason van de Leur, PhD

CONTACT

018-471 6802; jakob.clason-vandeleur@psyk.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This trial uses an open-label design in which participants and therapists are not masked to treatment allocation due to the nature of the psychological interventions. No additional parties are masked. Outcome data are collected through self-report questionnaires and registry-based sick-leave records, which are not influenced by treatment visibility. Statistical analysts will work with pseudonymized datasets, but this is for data protection rather than formal blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 9, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available beginning after publication of the primary results and for at least 5 years thereafter.
• Access Criteria: Deidentified individual participant data and supporting documents will be accessible to qualified researchers affiliated with an academic institution or research organization. Access will be granted for purposes such as replication, meta-analysis, or other scientifically sound projects that align with the original study objectives. Researchers must submit a written request to the Principal Investigator describing the planned analyses and data requirements. Before access is granted, applicants must sign a data-sharing agreement ensuring compliance with ethical approvals, Swedish data protection legislation, and GDPR. Approved users will be able to access the data through a secure institutional repository at Uppsala University or via encrypted data transfer. Only deidentified datasets and approved supporting documents (e.g., protocol, analytic code) will be shared; no directly identifiable information will be provided.