Feasibility and Acceptability of the Unified Protocol for Burnout

NCT07370038 | Not Yet Recruiting

• 1 other identifier: F&A:UP-B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The present study has three primary objectives: (1) to evaluate the feasibility of implementing the Unified Protocol for Burnout (UP-B) an intervention derived from the Unified Protocol (Barlow et al., 2018); (2) to assess the acceptability of the intervention among both recipients and psychotherapists; and (3) to examine preliminary signals of the UP-B's efficacy. The main questions it aims to answer are:

1. 1.Is the intervention feasible as indicated by recruitment rates, data collection procedures, and acceptable rates of participant retention and treatment completion?
2. 2.Is the UP-B acceptable for both participants and psychotherapists considering content, content structure, mode of delivery, and adherence?
3. 3.Does the UP-B show preliminary evidence of effectiveness (i.e., efficacy signals) in reducing burnout, anxiety, depression, and increasing well-being?

Conditions

Clinical Burnout

Keywords

transdiagnostic; cognitive-behavioral intervention; clinical burnout

Outcome Measures

Primary Outcomes (6)

• Feasibility of the UP-B

  Feasibility will be assessed in terms of recruitment capability, practicality, adaptability, and implementation fidelity. Recruitment capability refers to the number of participants successfully identified and enrolled. Practicality concerns whether the intervention can be delivered using available resources, time, training, and materials. Adaptability refers to the flexibility of the intervention procedures to accommodate diverse needs. Implementation fidelity refers to the extent to which professionals are able to deliver the intervention as intended.

  From baseline through post-intervention and 1-month follow-up

• Feasibility: Protocol fidelity (TARS-UP)

  Therapist adherence will be evaluated using the Therapist Adherence Rating Scale for the Unified Protocol (TARS-UP), adapted for use with the Unified Protocol for Burnout. Each intervention module will be evaluated by an observer using a checklist that captures the presence or absence of core treatment components and provides global ratings of therapist performance (e.g., rapport, engagement, session management, and overall session quality).

  From baseline to post-intervention (8 weeks)

• Module-Specific Acceptability (Participant Perspective)

  A questionnaire assessing participants' module-specific acceptability will be administered following each intervention module. The questionnaire includes five Likert-type items (two assessing group process and three assessing module content) and two open-ended questions designed to capture qualitative feedback.

  After each intervention module (across the intervention period)

• Module-Specific Acceptability (Psychotherapist Perspective)

  A brief module-specific acceptability questionnaire developed for this study will be administered to psychotherapists following delivery of each intervention module. The questionnaire consists of structured yes/no and yes/somewhat/no questions assessing implementation issues (e.g., barriers to delivery and adequacy of session time), numeric rating questions (1-10) assessing perceived fit of the module content and participant engagement, and open-ended questions allowing therapists to elaborate on their responses and provide feedback on strengths of the module and areas for improvement.

  After each intervention module (across the intervention period)

• Global Acceptability

  An 8-item questionnaire developed by Sekhon et al. (2022) will be used to assess acceptability of the intervention from both participant and psychotherapist perspectives. The questionnaire is based on the Theoretical Framework of Acceptability (TFA). Items corresponding to each TFA construct will be analysed separately. No composite total score will be calculated. Overall acceptability will be assessed using the single general acceptability item.

  Post-intervention (8 weeks)

• Behavioral indicators of Acceptability

  Attrition will be operationalized in terms of drop-out rates. Adherence will be operationalized as the number of sessions attended and the quality of completed homework assignments.

  Post-intervention (8 weeks)

Secondary Outcomes (6)

• Burnout

  From baseline through post-intervention and 1-month follow-up.

• Depression Severity

  From baseline through post-intervention and 1-month follow-up.

• Anxiety Severity

  From baseline through post-intervention and 1-month follow-up.

• Well-being

  From baseline through post-intervention and 1-month follow-up.

• Emotion Regulation

  From baseline through post-intervention and 1-month follow-up.

Study Arms (1)

Unified Protocol for Burnout

EXPERIMENTAL

All participants will be included in this program.

Behavioral: Unified Protocol for Burnout

Interventions

Unified Protocol for Burnout BEHAVIORAL

During the intervention, participants will complete eight modules designed to equip them with a defined set of skills for managing clinical burnout (i.e., understanding emotions, mindful emotion awareness, awareness and confrontation of physical sensations, cognitive flexibility, enhancement of cognitive functioning, and emotion-focused exposures). After each module, participants will be assigned homework exercises, which will be reviewed and discussed during the subsequent session.

Unified Protocol for Burnout

Eligibility Criteria

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

You may qualify if:

• Participants must score above the moderate burnout threshold on the Burnout Assessment Tool (BAT) to be considered eligible. Those who meet this cutoff will subsequently undergo a structured clinical interview to verify the presence of clinical burnout symptoms. The interview will assess whether the symptom profile is consistent with clinical burnout and will document the onset, progression, and course of symptoms. To be considered eligible for the study, the cause of symptoms must be burnout.

You may not qualify if:

• Current engagement in psychotherapy, defined as receiving ongoing psychological treatment at the time of screening;
• Current use of psychotropic medication (e.g., antidepressants, anxiolytics, mood stabilizers);
• Presence of a diagnosed personality disorder and as determined by the clinical interview;
• Presence of a psychiatric disorder;
• Presence or history of a psychotic disorder;
• Suicidal ideation, as assessed through the clinical interview.

Sponsors & Collaborators

• West University of Timisoara: lead

Study Sites (1)

West University of Timișoara

Timișoara, Timiș County, 300223, Romania

Location

Related Publications (9)

• World Health Organization. Regional Office for Europe; Wellbeing measures in primary health care / the DepCare Project: report on a WHO meeting: Stockholm, Sweden, 12-13 February 1998; World Health Organization. Regional Office for Europe; 1998

  BACKGROUND

• Bjureberg, J.; Ljótsson, B.; Tull, M. T.; Hedman, E.; Sahlin, H.; Lundh, L.-G.; Bjärehed, J.; DiLillo, D.; Messman-Moore, T.; Gumpert, C. H.; Gratz, K. L.; Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16; Journal of Psychopathology and Behavioral Assessment; 2016; 38; 284-296.

  BACKGROUND

• Bentley, K. H., Gallagher, M. W., Carl, J. R., & Barlow, D. H., Development and validation of the overall depression severity and impairment scale, Psychological assessment, 2014, 26(3), 815.

  BACKGROUND

• Schaufeli, W. B., De Witte, H. & Desart, S., Manual Burnout Assessment Tool (BAT) - Version 2.0, KU Leuven. 2020, Unpublished internal report.

  BACKGROUND

• Norman, S. B., Hami Cissell, S., Means-Christensen, A. J., & Stein, M. B., Development and validation of an overall anxiety severity and impairment scale (OASIS), Depression and anxiety, 2006, 23(4), 245-249.

  BACKGROUND

• Barlow, D. H., Unified protocol for transdiagnostic treatment of emotional disorders: Therapist guide, Oxford University Press, 2018. 2nd edition

  BACKGROUND

• Tasca, G. A., Cabrera, C., Kristjansson, E., MacNair-Semands, R., Joyce, A. S., & Ogrodniczuk, J. S. The Therapeutic Factors Inventory-8: Using item response theory to create a brief scale for continuous process monitoring for group psychotherapy. 2016. Psychotherapy Research, 26(2), 131-145

  BACKGROUND

• Tennant, R., Hiller, L., Fishwick, R., Platt, S., Joseph, S., Weich, S., Parkinson, J., Secker, J., & Stewart-Brown, S., The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. 2007. Health and quality of life outcomes, 5, 63.

  BACKGROUND

• Sekhon, M., Cartwright, M., & Francis, J. J. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC health services research, 2022, 22(1), 279.

  BACKGROUND

Study Officials

• Andrei Rusu, PhD

  West University of Timisoara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Athena Gândilă

CONTACT

+40747877850; athena.gandila99@e-uvt.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

RO (1)