- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06190353
Development, Acceptability and Preliminary Efficacy of an Internet-Based Self-Help Program
January 3, 2024 updated by: CanSagligi Foundation
Development, Acceptability and Preliminary Efficacy of an Internet-Based Self-Help Program Using Acceptance and Commitment Therapy for Coping With Burnout Among Healthcare Workers: A Randomized Controlled Pilot Study
This study aims to evaluate acceptability and initial effectiveness of an internet-based self-help program utilizing Acceptance and Commitment Therapy specifically for healthcare workers, intending to address burnout.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This pilot study is a randomized controlled trial of two parallel groups.
The study will comprise of an intervention and a wait-list control group.
The intention of this study is to evaluate the acceptability and preliminary efficacy of an internet-based self-help program with minimal telephone support utilizing Acceptance and Commitment Therapy for alleviating burnout among healthcare workers.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Havvanur Uysal Akdemir, MS
- Phone Number: +90 (212) 269 66 11
- Email: havvanur.uysal@cansagligivakfi.org
Study Locations
-
-
Uskudar
-
Istanbul, Uskudar, Turkey
- Recruiting
- CanSagligi Foundation
-
Contact:
- Eda Aksoy
- Phone Number: +90(216) 269 66 11
- Email: eda.aksoy@cansagligivakfi.org
-
Principal Investigator:
- Ahmet Nalbant, MD
-
Sub-Investigator:
- Havvanur Uysal Akdemir, MS
-
Sub-Investigator:
- Edanur Gürbüz, BA
-
Sub-Investigator:
- Kaasım Fatih Yavuz, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Currently employed in the healthcare field as a doctor, nurse, technician, pharmacist or other healthcare profession for a minimum of six months.
- Proficiency in using computer and email.
- Experiencing symptoms of burnout related to the workplace.
Exclusion Criteria:
- Currently prescribed psychotropic medication.
- Currently undergoing psychotherapy.
- Presently experiencing thoughts of suicide or self-mutilation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The experimental group which will have an immediate access to web-based psychotherapy.
|
An eight module self help program
|
No Intervention: Control
A wait-list control group which have one month delayed access to intervention program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burnout Assessment Tool
Time Frame: At baseline and 4 weeks
|
Burnout Assessment Tool is a validated measure which evaluates to what extend people experience burnout.
|
At baseline and 4 weeks
|
Valued Living Questionnaire (VLQ)
Time Frame: At baseline and 4 weeks
|
VLQ is a validated measure and its aim is to evaluate valued living.
|
At baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance and Action Questionnaire-2 (AAQ-2)
Time Frame: At baseline and 4 weeks
|
AAQ-2 is a measure aiming to evaluate experiential avoidance
|
At baseline and 4 weeks
|
System Usability Scale (SUS)
Time Frame: 4 weeks
|
SUS aims to measure evaluations of participants about an internet based program.
|
4 weeks
|
Attendance rate
Time Frame: 4 weeks
|
To evaluate feasibility, participants attendance rate to the program will be recorded.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmet Nalbant, MD, CanSagligi Foundation Center for Contextual Behavioral Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
January 3, 2024
First Posted (Actual)
January 5, 2024
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 3, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSV202301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data would be available upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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