Comparing the effectiveness of mindfulness-based cognitive therapy and compassion therapy on self-criticism, anxiety sensitivity, and task intolerance in women with generalized anxiety disorder
The aim of this study is to investigate and compare the effectiveness of mindfulness-based cognitive therapy and compassion therapy on reducing self-criticism, anxiety sensitivity, and intolerance of uncertainty in women with generalized anxiety disorder.
Design
A phase 2, randomized, parallel-group, controlled clinical trial on 45 patients. Participants were assigned to three groups (mindfulness-based cognitive therapy, compassion therapy, and control group). Randomization was performed in a simple manner using the rand function in SPSS software.
Settings and conduct
Location & Procedure:Conducted at Ahvaz psychology clinics, participants are screened by a psychiatrist before therapy. They receive mindfulness-based cognitive therapy or compassion therapy in controlled settings.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Having a diagnosis of generalized anxiety disorder according to psychiatric criteria.
2. Willingness to participate in the study and completing an informed consent form.
Exclusion criteria
1. Having a severe psychiatric disorder such as bipolar disorder or schizophrenia that may affect the results of the study.
2. Receiving concurrent psychological or pharmacological treatments that could interfere with the effectiveness of the treatments being studied.
Intervention groups
Intervention groups:
1. Mindfulness-based cognitive therapy
2. Compassion therapy
3. Control group (no intervention)
Main outcome variables
In this study, the outcome variables include self-criticism, anxiety sensitivity, and intolerance of uncertainty, which are measured as a result of mindfulness-based cognitive therapy and compassion therapy interventions. These variables will be measured at the beginning and end of the study and their changes will be analyzed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250315065094N1
Registration date:2025-05-29, 1404/03/08
Registration timing:registered_while_recruiting
Last update:2025-05-29, 1404/03/08
Update count:0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
masomeh ostad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4222 3225
Email address
4219881875a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2026-03-19, 1404/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of mindfulness-based cognitive therapy and compassion therapy on self-criticism, anxiety sensitivity, and task intolerance in women with generalized anxiety disorder
Public title
Comparing the effectiveness of mindfulness-based cognitive therapy and compassion therapy on psychological characteristics associated with generalized anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Receiving a diagnosis of generalized anxiety disorder based on the criteria of the Fifth Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and based on the diagnosis of the psychiatrist of the counseling center
2. Cooperation and support during the intervention period;
3. No other mental disorders are present at the same time as the diagnosis of the psychiatrist of the counseling center
4. Subjects agree and sign a written consent form
Exclusion criteria:
Continuous use of medication that could interfere with the interventions under study;
Failure to cooperate or attend 2 consecutive treatment sessions.
Age
From 20 years old to 36 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
Simple randomization method, individual unit, using sealed envelopes, in which a card is first prepared for each participant. These cards are usually numbered or marked to indicate the group to which they have been assigned. The cards are then placed in opaque, sealed envelopes. This is done to prevent researchers or participants from seeing the contents of the envelopes. Then, as each participant enters the study, an envelope is randomly selected. The contents of that card are removed and the group assigned to that individual is recorded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, Ahvaz Branch, Faculty of Humanities
Street address
Islamic Azad University, Ahvaz Branch, Faculty of Humanities
City
AHVAZ
Province
Khouzestan
Postal code
61349-37333
Approval date
2025-01-27, 1403/11/08
Ethics committee reference number
IR.IAU.AHVAZ.REC.1403.434
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Participants' self-criticism score after treatment
Timepoint
Before the start of treatment (pre-test), at the end of the intervention period (post-test), at the follow-up 3 months after the end of treatment
Method of measurement
Using the Self-Criticism Questionnaire (NQR), which consists of 20 questions with a five-level response scale from 1 (never) to 5 (always), an overall score is calculated based on the sum of the scores of the questions. A higher score indicates a greater level of self-criticism.
Secondary outcomes
1
Description
Participants' anxiety sensitivity levels after treatment
Timepoint
At the end of treatment and also at follow-up 3 months after the end of the treatment intervention
Method of measurement
Using the Anxiety Sensitivity Questionnaire (ASQ), consisting of 15 questions with a five-level response scale from 1 (strongly disagree) to 5 (strongly agree), the total score is calculated based on the sum of the scores of the questions. A higher score indicates greater anxiety sensitivity.
2
Description
Average Intolerance of Uncertainty Score after Treatment
Timepoint
At the end of the 8-week intervention period and at follow-up 3 months after the end of treatment
Method of measurement
Using the Intolerance of Task Difficulty Scale (IRTQ), which consists of 10 questions with a five-level response, a total score is calculated by summing the scores of the questions. A higher score indicates greater intolerance of task difficulty.
Intervention groups
1
Description
Experimental group 1: Mindfulness-based cognitive therapy - Treatment method: This treatment includes training in present-moment awareness skills, acceptance of thoughts and feelings, and mindfulness meditation exercises. - Number of sessions: 8 therapy sessions - Duration of each session: 90 minutes - Duration of the course: 8 weeks - Session content: Includes training in mindfulness exercises, emotion regulation techniques, and strategies for reducing self-criticism and anxiety - Tools used: Exercise booklet, meditation audio files, and treatment guide
Category
Behavior
2
Description
Intervention group: Experimental group 2: Compassion therapy- Treatment method: This intervention includes training in techniques to increase self-compassion, reduce internal criticism, and exercises related to positive emotions and acceptance.- Number of sessions: 8 therapy sessions- Duration of each session: 90 minutes- Duration of the course: 8 weeks- Content of the sessions: Mental exercises to cultivate compassion, techniques to reduce anxiety related to self-criticism, and emotional acceptance training- Tools used: Exercise booklet, audio files of compassion guidance, and educational resources
Category
Behavior
3
Description
Control group: Control group: Control group: - Intervention: This group does not receive any therapeutic intervention and only routine research assessments are performed on them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
**Islamic Azad University, Ahvaz Branch**
Full name of responsible person
**Fariba Hafezi, Advisor and Associate Professor**
Street address
Culture City, Islamic Azad University, Ahvaz Branch
City
AHVAZ
Province
Khouzestan
Postal code
61349-37333
Phone
+98 916 662 5982
Email
saman.toonjak@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Full name of responsible person
**Fariba Hafezi, Advisor and Associate Professor
Street address
Islamic Azad University, Ahvaz Branch
City
ahvaz
Province
Khouzestan
Postal code
61349-37333
Phone
+98 916 662 5982
Email
saman.toonjak@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
It is entirely funded by the student.
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Fariba Hafezi and Masoumeh Ostad
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Fazhang City, Islamic Azad University, Ahvaz Branch
City
ahvaz
Province
Khouzestan
Postal code
61349-37333
Phone
+98 916 662 5982
Email
iamhihro@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Fariba Ahafzi and Masoumeh Ostad
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Culture City of Islamic Azad University
City
ahvaz
Province
Khouzestan
Postal code
61349-37333
Phone
+98 916 662 5982
Email
iamhihro@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masomeh Ostad
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Golzar Shohada Road, next to Matin Cooperative Company
City
Poldokhtar
Province
Lorestan
Postal code
61349-37333
Phone
+98 66 4222 3225
Fax
Email
4219881875a@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In this study, individual patient data (IPD) will not be published. The reasons for non-publication include the following:
1. Maintaining confidentiality and privacy of participants: Due to the sensitive nature of the data, the personal and clinical information of the participants is protected and will not be published.
2. Legal and ethical requirements: According to ethical regulations and research guidelines, the publication of personal data requires specific consent and strict security controls.
3. Inability to completely anonymize data: Given the structure of the data, even after removing personal details, the data may remain identifiable, which increases the risk of revealing the identity of the participants.
4. Legal and organizational restrictions: Some institutions and organizations related to this study do not allow the publication of raw personal data, and public publication requires legal approval.
5. Research objectives and analysis method: The analyses used in this study are designed to present general results and there is no need to publish individual data.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available