The effectiveness of cognitive behavioral therapy based on mindfulness on emotional regulation, metacognitive ability, and cognitive flexibility in patients with mood disorders .
Determining the Effectiveness of Mindfulness-Based Cognitive Therapy on Emotion Regulation, Metacognitive Ability, and Cognitive Flexibility in Patients with Mood Disorders
Design
randomized controlled clinical trial with a parallel-group, pre-test/post-test design conducted on 68 hospitalized patients with mood disorders. Participants are randomly allocated using simple randomization (via SPSS software version 22) into two equal groups . The intervention group receives MBCT in addition to routine treatment, while the control group receives routine treatment only. The outcome assessor and data analyst will be blinded to group allocation.
Settings and conduct
68 patients with mood disorders in the psychiatric ward of Farabi Hospital in Isfahan. The intervention group received 8 sessions of mindfulness-based cognitive-behavioral group therapy in addition to routine treatment, and the control group received only routine treatment.
Participants/Inclusion and exclusion criteria
Inclusion: Age 20-50, hospitalized at Farabi Hospital with mood disorder, literate, consenting, without severe mental illness/substance abuse. Exclusion: Condition exacerbation, withdrawal, or >3 absences.
Intervention groups
Intervention group: This group includes patients with mood disorders (depression or bipolar disorder) of moderate to severe intensity. They receive mindfulness-based cognitive-behavioral therapy (MBCT) in eight group sessions, each lasting 45 minutes.
Control group: This group includes patients with mood disorders of moderate to severe intensity who receive only the routine psychiatric care provided by the hospital.
The effectiveness of cognitive behavioral therapy based on mindfulness on emotional regulation, metacognitive ability, and cognitive flexibility in patients with mood disorders .
Public title
he Effect of Mindfulness-Based Cognitive Behavioral Therapy on Emotion and Cognitive Function in Patients with Mood Disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum literacy (ability to read and write)...
Diagnosis of a mood disorder confirmed by a psychiatrist
Hospitalization at Farabi Hospital
Age range between 20 and 50 years.
Written informed consent to participate in the study
Exclusion criteria:
Severe mental disorders (as diagnosed by a psychiatrist) impeding participation in patient education sessions.
history of substance abuse.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
68
More than 1 sample in each individual
Number of samples in each individual:
34
Allocation will result in 34 participants in the intervention group and 34 in the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple individual-level randomization will be used. After eligibility is confirmed and the baseline assessment is completed, each participant will be randomly assigned to either the intervention or control group. The random sequence will be generated by an independent statistician using SPSS software, and the allocation list will be kept confidential by the statistician.
For allocation concealment, a central allocation method will be used: once the participant’s baseline information is fully recorded, the implementing researcher will contact the statistician to obtain the assigned group. Therefore, the implementer will have no prior knowledge of the participant’s group.
Additionally, the person collecting the questionnaires will be blinded to the participants’ group assignments, and the data will be provided to the statistical analyst in a coded form (Groups 1 and 2) to ensure analyses are conducted without knowledge of the intervention type. The codes will only be revealed after the analysis is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
To ensure impartiality, data analysis will be conducted in a single-blind manner. Raw data, after group coding with neutral labels (e.g., Group 1 and Group 2) and without disclosure of the type of intervention, will be provided to the analyst. The analyst will perform all statistical tests based solely on these codes and will remain unaware of the allocation of each group to the intervention or control until the initial analysis is completed. This process prevents bias in the analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746‑73461
Approval date
2026-01-20, 1404/10/30
Ethics committee reference number
IR.MUI.NUREMA.REC.1404.159
Health conditions studied
1
Description of health condition studied
Bipolar affective disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Emotion regulation refers to an individual’s ability to recognize, manage, and control their emotions in a way that responses are appropriate to the context, goals, and social situations. This skill includes identifying emotions, modulating their intensity and duration, and selecting suitable strategies to cope with negative emotions or enhance positive ones. Emotion regulation plays a key role in mental health, decision-making, cognitive flexibility, and interpersonal relationships.
Metacognitive ability refers to an individual’s skill in awareness, monitoring, and control of their own cognitive processes. This ability includes recognizing one’s thoughts and beliefs, understanding cognitive strengths and limitations, and managing strategies for problem-solving and decision-making. Metacognition plays a key role in learning, cognitive flexibility, self-regulation, and mental health enhancement.
Timepoint
pre and post intervention
Method of measurement
Wells’ Metacognitions Questionnaire
3
Description
Cognitive flexibility refers to an individual’s ability to adapt their thoughts, attitudes, and behaviors according to new or unexpected situations. This skill includes the capacity to view problems from different perspectives, select alternative strategies, and adjust to environmental changes, playing a key role in problem-solving, decision-making, and stress management.
Timepoint
pre and post intervention
Method of measurement
Dennis & Vander Wal’s Cognitive Flexibility Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention for the experimental group consists of a structured psychological protocol that combines cognitive-behavioral therapy (CBT) and mindfulness exercises (Mindfulness-Based Cognitive Therapy, MBCT). The primary goal of this intervention is to help patients with mood disorders (depression or bipolar disorder) increase awareness of their present-moment thoughts and feelings without judgment or automatic reactions. The intervention is delivered in the form of 8 in-person group sessions, each lasting 45 minutes, following the standard MBCT protocol, with sessions held three times per week. The total duration of the intervention is approximately three weeks. Sessions are led by a clinical psychologist trained in MBCT and include theoretical instruction, practical exercises, group discussions, and homework assignments. The session content includes the following:• Introduction to the concept of mindfulness and its importance in mood and emotion regulation• Body scan exercises and breathing practices• Identifying and observing thoughts and feelings as transient phenomena• Mindfulness practice in daily activities• Developing a non-judgmental attitude and acceptance without automatic reaction special equipment is required for the intervention other than a group therapy room, chairs, and the ability to play audio files (for some guided meditations). It should be noted that all participants are simultaneously receiving routine psychiatric care at the hospital, and the MBCT intervention is provided as an adjunctive therapy.
Category
Lifestyle
2
Description
Control Group: Participants in this group do not receive any structured mindfulness-based cognitive-behavioral therapy sessions. Their intervention consists of standard routine psychiatric care provided by the hospital. This care includes regular follow-up by the treating psychiatrist for medication management, administration of prescribed psychiatric medications (with names, doses, and frequency according to the physician’s prescription), and routine nursing and environmental care on the ward. No educational programs, structured group therapy sessions, or other specific psychological interventions will be provided to this group during the study period. Like other hospitalized patients, members of this group receive only medical supervision and treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital, Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Fatemeh Lohrasebi Nejad
Street address
3th Moshtagh
City
Isfahan
Province
Isfehan
Postal code
8155113153
Phone
+98 31 3792 7607
Email
Flohrasebi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7514
Email
Akbari@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Lohrasebi Nejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7607
Email
Flohrasebi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Lohrasebi Nejad
Position
Assistant prifessor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7607
Email
Flohrasebi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Lohrasebi Nejad
Position
Assiatant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7607
Email
Flohrasebi@nm.mui.ac.ir
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
Key data include: scores from the Cognitive Emotion Regulation Questionnaire (CERQ), metacognitive ability (Wells Questionnaire), cognitive flexibility (Dennis & Vanderwal), and baseline/demographic data such as age, sex, marital status, and hospitalization history.
When the data will become available and for how long
The access to de-identified participant data and related documents will begin **6 months after the publication of the study results** and will remain available for **5 years**.
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
The de-identified participant data and related documents may be used only for scientific research purposes and secondary analyses related to the study topic. Requests for access to the data must be submitted by independent researchers with a clear research proposal and, upon approval by the ethics committee or the responsible research team, the data will be provided to the requester. Any publication of secondary results must cite the original study, and commercial use of the data is not permitted. Additionally, the requester is required to maintain data confidentiality and must refrain from any attempt to identify study participants.
From where data/document is obtainable
Fatemeh Lohrasebi
Flohrasebi@nm.mui.ac.ir
What processes are involved for a request to access data/document
After submitting a request for access to the data and documents along with a research proposal, the request will be reviewed by the study team and the ethics committee. Once approved, the de-identified data and documents will be provided to the requester through a secure method. This process typically takes 4 to 8 weeks.