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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unified Protocol for Burnout | Experimental | All participants will be included in this program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Burnout | Burnout will be assessed using the Burnout Assessment Tool-23 (BAT-23; Schaufeli et al., 2020), a 23-item self-report measure rated on a 5-point Likert-type scale. The BAT-23 assesses core burnout symptoms, which can be analysed separately or as a composite score, as well as secondary distress symptoms, which are summed and interpreted as a single score. | From baseline through post-intervention and 1-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Athena Gândilă | Contact | +40747877850 | athena.gandila99@e-uvt.ro |
| Name | Affiliation | Role |
|---|---|---|
| Andrei Rusu, PhD | West University of Timisoara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West University of Timișoara | Timișoara | Timiș County | 300223 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 27239096 | Background | 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. | |
| 24708078 |
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| 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) |
| Depression Severity | To assess depression severity, the Overall Depression Severity and Impairment Scale (ODSIS-5; Bentley et al., 2014) will be used. The ODSIS-5 is a 5-item Likert-type scale, with total scores ranging from 0 to 20. Higher scores indicate greater depression severity. | From baseline through post-intervention and 1-month follow-up. |
| Anxiety Severity | To assess anxiety severity, the Overall Anxiety Severity and Impairment Scale (OASIS-5; Norman et al., 2006) will be used. The OASIS-5 is a 5-item Likert-type scale, with total scores ranging from 0 to 20. Higher scores indicate greater anxiety severity. | From baseline through post-intervention and 1-month follow-up. |
| Well-being | Well-being will be assessed using the The World Health Organization-Five Well-Being Index (WHO-5), a 5-item self-report measure rated on a 6-point Likert-type scale (World Health Organization, Regional Office for Europe, 1998). Total scores range from 0 to 25, with higher scores indicating greater well-being. | From baseline through post-intervention and 1-month follow-up. |
| Emotion Regulation | Emotional regulation will be assessed using the Difficulties in Emotional Regulation scale -16 (DERS-16; Bjureberg et al., 2016), an 16-item self-report measure rated on a 5-point Likert scale. Item responses will be summed to yield a total score ranging from 16 to 80, with higher scores indicating greater difficulties in emotion regulation. | From baseline through post-intervention and 1-month follow-up. |
| Group factors | Group therapeutic processes will be assessed using the Therapeutic Factors Inventory-8 (TFI-8; Tasca et al., 2014), an 8-item self-report measure rated on a 7-point Likert scale. Item responses will be summed to yield a total score ranging from 8 to 56, with higher scores indicating stronger perceived group therapeutic factors. | Post-intervention (8 weeks) |
| Background |
| 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. |
| Background | Schaufeli, W. B., De Witte, H. & Desart, S., Manual Burnout Assessment Tool (BAT) - Version 2.0, KU Leuven. 2020, Unpublished internal report. |
| 16688739 | Background | 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. |
| Background | Barlow, D. H., Unified protocol for transdiagnostic treatment of emotional disorders: Therapist guide, Oxford University Press, 2018. 2nd edition |
| 25297516 | Background | 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. |
| 18042300 | 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. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. |
| 35232455 | Background | Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3. |