Feasibility and Acceptability of the Unified Protocol for Burnout

Official title

Implementing the Unified Protocol for Burnout (UP-B): A Feasibility and Acceptability Study.

Overview

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

Detailed description

This research employs a single-arm, open-label trial design with a one-month follow-up assessment. In addition, two post-intervention focus groups will be conducted-one with participating psychotherapists and one with participants-to explore potential barriers to implementation and to identify the strengths and weaknesses of the intervention.

The Unified Protocol for Burnout consists of eight modules delivered in a group format, with approximately eight participants per group. The intervention is administered across eight two-hour sessions and is designed to treat clinical burnout. Participants will learn a set of transdiagnostic skills aimed at improving their ability to manage burnout and associated symptoms, such as anxiety and depression. These skills include mindful emotion awareness, cognitive flexibility, and strategies for countering maladaptive emotional behaviors.

The psychotherapists involved in the study (n= 3) will receive specialized training in the Unified Protocol and will be supervised throughout the intervention by two licensed clinical psychologists and psychotherapists with extensive experience in developing and implementing the Unified Protocol.

Interventions

• Behavioral Unified Protocol for Burnout
  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.

Primary outcome measures

• Feasibility of the UP-B [Time frame: From baseline through post-intervention and 1-month follow-up]
• Feasibility: Protocol fidelity (TARS-UP) [Time frame: From baseline to post-intervention (8 weeks)]
• Module-Specific Acceptability (Participant Perspective) [Time frame: After each intervention module (across the intervention period)]
• Module-Specific Acceptability (Psychotherapist Perspective) [Time frame: After each intervention module (across the intervention period)]
• Global Acceptability [Time frame: Post-intervention (8 weeks)]
• Behavioral indicators of Acceptability [Time frame: Post-intervention (8 weeks)]

Secondary outcome measures (6)

• Burnout [Time frame: From baseline through post-intervention and 1-month follow-up.]
• Depression Severity [Time frame: From baseline through post-intervention and 1-month follow-up.]
• Anxiety Severity [Time frame: From baseline through post-intervention and 1-month follow-up.]
• Well-being [Time frame: From baseline through post-intervention and 1-month follow-up.]
• Emotion Regulation [Time frame: From baseline through post-intervention and 1-month follow-up.]
• Group factors [Time frame: Post-intervention (8 weeks)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Romania · 1 center

• West University of Timișoara — Timișoara

Publications

• 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
• Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14. PMID 27239096
• Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7. PMID 24708078
• Schaufeli, W. B., De Witte, H. & Desart, S., Manual Burnout Assessment Tool (BAT) - Version 2.0, KU Leuven. 2020, Unpublished internal report.
• Norman SB, Cissell SH, Means-Christensen AJ, Stein MB. Development and validation of an Overall Anxiety Severity And Impairment Scale (OASIS). Depress Anxiety. 2006;23(4):245-9. doi: 10.1002/da.20182. PMID 16688739
• Barlow, D. H., Unified protocol for transdiagnostic treatment of emotional disorders: Therapist guide, Oxford University Press, 2018. 2nd edition
• Tasca GA, Cabrera C, Kristjansson E, MacNair-Semands R, Joyce AS, Ogrodniczuk JS. The therapeutic factor inventory-8: Using item response theory to create a brief scale for continuous process monitoring for group psychotherapy. Psychother Res. 2016;26(2):131-45. doi: 10.1080/10503307.2014.963729. Epub 2014 Oct 8. PMID 25297516
• 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. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. PMID 18042300

Identifiers

NCT: NCT07370038 · F&A:UP-B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗