Feasibility and Acceptability of the Unified Protocol for Burnout

N/ANot Yet RecruitingNCT07370038

West University of Timisoara24 enrolled

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?

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

Interventions

Unified Protocol for BurnoutBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Post-intervention (8 weeks)

Secondary Outcomes

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.