Feasibility and Acceptability of the Unified Protocol for Burnout
ConditionClinical Burnout
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest University of Timisoara
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Unified Protocol for Burnout
BehavioralDuring 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Unified Protocol for BurnoutExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-up2
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)3
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)4
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)Secondary outcomes
1
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.
Time frame
From baseline through post-intervention and 1-month follow-up.2
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.
Time frame
From baseline through post-intervention and 1-month follow-up.3
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.
Time frame
From baseline through post-intervention and 1-month follow-up.4
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.
Time frame
From baseline through post-intervention and 1-month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: