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A Comparison of the Effectiveness of Dialectical Behavior Therapy and Mindfulness-Based Cognitive Therapy Packages on Weight-Related Self-Efficacy, Fear of Negative Evaluation, and Psychological Distress in Patients with Obesity.

Protocol summary

Study aim
A Comparison of the Effectiveness of Dialectical Behavior Therapy (DBT) and Mindfulness-Based Cognitive Therapy (MBCT) Packages on Weight-Related Self-Efficacy, Fear of Negative Evaluation, and Psychological Distress in Patients with Obesity
Design
A clinical trial with a control group, parallel groups, unblinded, randomized, on 45 patients
Settings and conduct
The present study will be conducted as a quasi-experimental study among individuals with obesity who refer to medical centers in Tehran. Using purposive sampling method, 45 participants will be selected based on the study's inclusion criteria. They will then be randomly assigned to three groups: experimental group 1, experimental group 2, and a control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having literacy skills for reading and writing, not taking any medication, at least 2 years have passed since the diagnosis of obesity, Body Mass Index between 30 and 35, age range between 18 and 45 years. Exclusion Criteria: Substance and alcohol abuse, receiving psychological interventions during the past 6 months, having chronic physical illnesses or psychological disorders.
Intervention groups
Intervention Group 1: DBT 8 weekly 90-min group sessions. Content: Intro, emotional awareness, self-acceptance, craving control, inner/outer wisdom, meditation, mind-body-emotion connection, post-test. Intervention Group 2: MBCT 8 weekly 90-min group sessions. Content: Intro, distress tolerance, mind levels, emotion management, nutrition, chain analysis (binge eating), behavior management, post-test. Control Group No intervention during study; receives treatment post-study (optional).
Main outcome variables
Weight-related self-efficacy, fear of negative evaluation, and psychological distress.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251101067851N1
Registration date: 2026-03-15, 1404/12/24
Registration timing: registered_while_recruiting

Last update: 2026-03-15, 1404/12/24
Update count: 0
Registration date
2026-03-15, 1404/12/24
Registrant information
Name
Sahar Saeidiasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 4096
Email address
sahar.saeidiasl@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-01, 1404/12/10
Expected recruitment end date
2026-04-14, 1405/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the Effectiveness of Dialectical Behavior Therapy and Mindfulness-Based Cognitive Therapy Packages on Weight-Related Self-Efficacy, Fear of Negative Evaluation, and Psychological Distress in Patients with Obesity.
Public title
A Comparison of the Effect of Behavioral Therapy Packages on Mindfulness in Patients with Obesity.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having literacy skills for reading and writing Willingness to participate in the study and complete the consent form to receive the therapeutic intervention Not taking any medication At least 2 years have passed since the diagnosis of obesity Body Mass Index (BMI) between 30 and 35 Age range between 18 and 45 years old
Exclusion criteria:
Substance and alcohol abuse. Receiving psychological interventions during the past 6 months. Having chronic physical illnesses or psychological disorders.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The sample of the present study will be selected using purposive sampling. Specifically, from among individuals with obesity who will refer to selected medical centers in Tehran during the study period and who meet the study's inclusion and exclusion criteria, 45 individuals will be selected. The random sequence will be generated using Random Allocation Software by someone outside the research team (a research assistant). The method used will be simple randomization with equal allocation ratio (1:1:1) for the three groups. That is, the software will generate a random list of 45 numbers consisting of 1, 2, and 3 (corresponding to Experimental Group 1, Experimental Group 2, and Control Group, respectively). The process of randomly allocating these 45 participants into three groups of 15 will be carried out as follows: After obtaining informed consent and completing the pre-test, each participant will be assigned a unique identification code. Then, based on the random sequence generated by the software, participants will be placed into one of the three groups in the order they enter the study (from code 1 to 45). All allocation steps will be performed by a research assistant who will not be involved in the subsequent intervention and assessment stages, and the final result will be recorded and stored in sealed envelopes to maintain the principle of allocation concealment. Due to the psychological nature of the interventions, blinding the interventionist and participants will not be possible; however, to reduce measurement bias, the primary outcome assessor (the person collecting the post-test data) will be kept unaware of each participant's group assignment (blinded assessment).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Research Ethics Committee of Islamic Azad University - Tehran North Branch
Street address
5th Floor, Shahid Fakhrizadeh Research and Laboratory Building, Islamic Azad University, Tehran North Branch, Vafadar Boulevard, Shahid Sadoughi Street, Hakimiyeh Exit, Shahid Babaei Highway (Westbound), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1651153511
Approval date
2025-09-06, 1404/06/15
Ethics committee reference number
IR.IAU.TNB.REC.1404.241

Health conditions studied

1

Description of health condition studied
Patients with obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Weight-related self-efficacy
Timepoint
Before the start of the intervention and at the end of the intervention sessions.
Method of measurement
Weight Self-Efficacy Questionnaire (WSEQ)

2

Description
Fear of negative evaluation
Timepoint
Before the start of the intervention and at the end of the intervention sessions.
Method of measurement
Brief Fear of Negative Evaluation Scale

3

Description
Psychological distress
Timepoint
Before the start of the intervention and at the end of the intervention sessions.
Method of measurement
Depression Anxiety Stress Scales

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention Group (Dialectical Behavior Therapy): The content of this intervention was extracted using the research synthesis method based on dialectical behavior therapy, and its validity was confirmed by expert professors. This intervention was delivered to participants in eight 90-minute group sessions over 8 weeks (one session per week). Detailed session content: Session 1 (Introduction and Conceptualization): Introduction, motivation building and case conceptualization, creating a safe space and introducing group rules, teaching the psychological model of obesity; Session 2 (Emotional Awareness and Identifying Real Needs): Types of hunger, increasing emotional awareness, and identifying real needs; Session 3 (Teaching the Inner Critic, Cultivating Self-Acceptance): Introducing and identifying mental wandering; Session 4 (Controlling Cravings and Temptations); Session 5 (Teaching Inner and Outer Wisdom); Session 6 (Breathing and Mindful Meditation Exercises); Session 7 (Integrating the Mind-Body-Emotion Connection); Session 8 (Session Summary and Post-test Administration).
Category
Treatment - Other

2

Description
Second Intervention Group: Mindfulness-Based Cognitive Therapy: The content of this intervention was extracted using the research synthesis method based on mindfulness-based cognitive therapy for binge eating and obesity, and its validity was confirmed by expert professors. This intervention was delivered to participants in eight 90-minute group sessions over 8 weeks (one session per week).Detailed session content: Session 1 (Introduction and Conceptualization): Establishing a therapeutic relationship, presenting the dialectical framework (acceptance vs. change), defining weight-related problems in terms of difficulty managing emotions and behaviors, and setting realistic personal goals. Session 2 (Distress Tolerance and Flexibility): Teaching survival skills for distressing situations without resorting to binge eating. Session 3 (Levels of Mind): Increasing awareness of different states of mind and their impact on decision-making and eating behaviors. Session 4 (Emotion Management): Identifying, naming, and modulating problematic emotions instead of suppressing them or acting impulsively. Session 5 (Nutrition and Body Awareness): Providing scientifically-based nutritional information (with a non-restrictive, acceptance-based approach), without imposing strict diets, and fostering a healthy relationship with the body and food. Session 6 (Chain Analysis of Events Contributing to Binge Eating): Precise and personalized identification of triggers, thoughts, emotions, and consequences related to binge eating. Session 7 (Managing Unhealthy Behaviors and Thought Patterns): Modifying dysfunctional beliefs about food, body, and self, reducing weight-related avoidance behaviors, and interpersonal skills training. Session 8 (Session Summary, Mindful Attention, Post-test): Reviewing and integrating skills, assessing progress, and developing a plan to maintain achievements, cope with future challenges, and prevent relapse.
Category
Treatment - Other

3

Description
Control group: does not receive any intervention.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Borna Specialized Rehabilitation Polyclinic
Full name of responsible person
Sahar Saeidiasl
Street address
599, 5th Floor, Units 18, 19, 20, Corner of Mashayekhi Alley, Solaymaniyeh Intersection, Piroozi Street.
City
Tehran
Province
Tehran
Postal code
1735745466
Phone
+98 912 071 4972
Email
dr.s.saeidi62@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rahmatollah Keramati Asl
Street address
Islamic Azad University, International Branch of Kish, Jahan Road, Kish Island, Iran
City
Kish Island
Province
Hormozgan
Postal code
7941775883
Phone
+98 912 071 4972
Email
4250589234@iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Kish International Branch
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahar Saeigiasl
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 18, No. 12, 20th Western Alley, Allameh North Street, Sarv Sharghi Street, Kaj Square, Sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1997977449
Phone
+98 21 2213 4096
Email
dr.s.saeidi62@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahar Saeidiasl
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 18, No. 12, 20th Western Alley, Allameh North Street, Sarv Sharghi Street, Kaj Square, Sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1997977449
Phone
+98 21 2213 4096
Email
dr.s.saeidi62@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahar Saeidiasl
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 18, No. 12, 20th Western Alley, Allameh North Street, Sarv Sharghi Street, Kaj Square, Sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1997977449
Phone
+98 21 2213 4096
Email
dr.s.saeidi62@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after the participants have been de-identified.
When the data will become available and for how long
Access begins 6 months after final publication.
To whom data/document is available
Eligible applicants include researchers, healthcare professionals (e.g., physicians, psychologists, nutritionists), and postgraduate students (Master’s or Doctoral level) in fields such as psychology, public health, medicine, and related disciplines. Submission of a data access request is permitted following verification of academic credentials and purpose by the Principal Investigator.
Under which criteria data/document could be used
The data and documentation from this study are available for research, educational, and therapeutic development purposes. Access is granted subject to the approval of a formal research proposal by the Principal Investigator and strict adherence to confidentiality protocols, including full data anonymization.
From where data/document is obtainable
Correspondence email: dr.s.saeidi62@gmail.com
What processes are involved for a request to access data/document
Applicants for data who are currently enrolled in a graduate program in one of the fields of psychology, health psychology, therapists and psychology specialists, nutritionists, or physicians can obtain the data file after submitting their documents to the researcher's email address.
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