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IRCT20250315065094N1 IRCT 2025-05-29 Islamic Azad University, Ahvaz Branch Comparing the effectiveness of mindfulness-based cognitive therapy and compassion therapy on psychological characteristics associated with generalized anxiety 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 2025-03-21 anticipated 45 Complete https://irct.ir/trial/82853 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, 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. N/A Generalized anxiety disorder. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: Control group: Control group: - Intervention: This group does not receive any therapeutic intervention and only routine research assessments are performed on them. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Fariba Hafezi and Masoumeh Ostad
Fazhang City, Islamic Azad University, Ahvaz Branch
ahvaz Iran (Islamic Republic of) 61349-37333 +98 916 662 5982 iamhihro@gmail.com Islamic Azad University, Ahvaz Branch scientific Fariba Ahafzi and Masoumeh Ostad
Culture City of Islamic Azad University
ahvaz Iran (Islamic Republic of) 61349-37333 +98 916 662 5982 iamhihro@gmail.com Islamic Azad University, Ahvaz Branch Iran (Islamic Republic of) 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 20 years 36 years Both Continuous use of medication that could interfere with the interventions under study; Failure to cooperate or attend 2 consecutive treatment sessions. Behavior Behavior Behavior 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 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 Control group: Control group: Control group: - Intervention: This group does not receive any therapeutic intervention and only routine research assessments are performed on them. 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. 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. 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. It is entirely funded by the student. Approved 2025-01-27 Islamic Azad University, Ahvaz Branch, Faculty of Humanities Islamic Azad University, Ahvaz Branch, Faculty of Humanities AHVAZ Khouzestan Iran (Islamic Republic of)