]>
IRCT20130904014564N3 IRCT 2026-05-30 Vice-chancellor for Research and Technology, Kharazmi University Comparing the Efficacy of Meta-Inner Humor Therapy (MIHT) versus ‎Mindfulness-Based Cognitive Therapy (MBCT) for Generalized Anxiety Disorder with or without ‎Major Depressive Disorder Comparing the Efficacy and Mechanisms of Change of Meta-Inner Humor Therapy (MIHT) versus ‎Mindfulness-Based Cognitive Therapy (MBCT) for Generalized Anxiety Disorder with or without ‎Major Depressive Disorder: A Multilevel Longitudinal Randomized Controlled Trial 2026-06-20 anticipated 90 Complete https://irct.ir/trial/90403 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sample Size and Randomization The sample size will be estimated using Monte Carlo simulations within the simr package in R, ensuring that the Group × Time interaction is detectable with a minimum power of 90% at a significance level of 0.05. Accounting for a 15% attrition rate, the target sample size is set at 90 participants, with 45 participants per treatment arm. Participants will be stratified by diagnostic status (GAD alone vs. GAD + MDD), and other comorbidities will be included as covariates in the analyses. Subsequently, participants will be allocated to one of the two treatment groups—MMIH or MBCT-GAD—using block randomization with a block size of 6. The randomization process will be managed by the REDCap randomizer algorithm to ensure a complete audit trail of the randomization procedure, Blinding description: Blinding and Allocation The allocation process will be double-blind for outcome assessors, therapist, and data analysts. An independent researcher, who has no involvement in participant interaction, will manage the allocation using sequentially numbered, opaque, sealed envelopes. Outcome assessors and statistical analysts will remain completely blinded to the assigned treatment groups. Therapeutic effects will be compared between the two groups at four time points: pre-treatment (baseline), post-treatment (week 10), and at 3-month and 6-month follow-ups. 3 Generalized Anxiety Disorder with or without Major Depressive Disorder. Intervention 1: Intervention group: Meta-Inner Humor Therapy (MMIH). Intervention 2: Intervention group: Mindfulness-Based Cognitive Therapy (MBCT). Yes - There is a plan to make this available What will be shared: Information on the main outcome of the research will be shared. When: Access begins 6 months after results are published. To whom: Data and other scientific documentation can be made available to any person who requests it. Conditions: There are no specific restrictions. Where to obtain: To access the data, you can send a message to Dr.Mehdi Akbari's email address: Akbari.psy@gmail.com or m.akbari@khu.ac.ir How to obtain: One month after the requester sends a message to one of the two emails mentioned in the previous section, individuals can receive the requested information. Comments:
public Mehdi Akbari
No.43, South Mofateh St, Kharazmi University, Tehran, Iran
Tehran Iran (Islamic Republic of) 15719-14911 +98 21 8832 9220 m.akbari@khu.ac.ir Kharazmi University scientific Mehdi Akbari
No.43, South Mofateh St, Kharazmi University, Tehran, Iran
Tehran Iran (Islamic Republic of) 15719-14911 +98 21 8832 9220 m.akbari@khu.ac.ir Kharazmi University Iran (Islamic Republic of) Inclusion Criteria:a) Participants must have Generalized Anxiety Disorder (GAD) as their primary diagnosis, which may present either in isolation or with comorbid Major Depressive Disorder (MDD). Other comorbid disorders, if present, will be recorded and included as covariates in the analyses. Diagnoses will be established based on the DSM-5 using the Structured Clinical Interview for DSM-5 (SCID-5) to ensure diagnostic accuracy and consistency in sample selection. Consequently, the study sample will consist of adults with GAD (with or without depressive comorbidity) who meet the required eligibility criteria.b) Age 18 years or older.c) Provision of written informed consent.Exclusion Criteria:a) Current or lifetime diagnosis of any psychotic disorder, bipolar disorder, severe personality disorders, substance use disorder, or any debilitating medical condition (such as an uncontrolled chronic illness).b) Presence of active suicidal ideation or behavior.Stable psychiatric medication use (e.g., SSRIs, SNRIs, benzodiazepines) is permitted, provided that the dosage has remained unchanged for the past 6 months and remains stable throughout the course of the treatment. 18 years 70 years Both Treatment - Other Treatment - Other Intervention group: Meta-Inner Humor Therapy (MMIH) Intervention group: Mindfulness-Based Cognitive Therapy (MBCT) Severity of generalized anxiety disorder symptoms with or without major depressive disorder. Timepoint: Baseline, post-treatment (week 10), 3-month follow-up, and 6-month follow-up. Method of measurement: The Generalized Anxiety Disorder symptoms questionnaire to assess generalized anxiety disorder symptoms, and the Patient Health Questionnaire-9 (PHQ-9) to assess major depressive disorder symptoms. Worry. Timepoint: Baseline, post-treatment (week 10), 3-month follow-up, and 6-month follow-up. Method of measurement: Penn State Worry Questionnaire (PSWQ). Satisfaction With Life. Timepoint: Baseline, post-treatment (week 10), 3-month follow-up, and 6-month follow-up. Method of measurement: Satisfaction With Life Scale (SWLS). Meta-Inner Humor Beliefs. Timepoint: Baseline, post-treatment (week 10), 3-month follow-up, and 6-month follow-up. Method of measurement: Meta-Inner Humor Beliefs Scale. Mindfulness. Timepoint: Baseline, post-treatment (week 10), 3-month follow-up, and 6-month follow-up. Method of measurement: Five Facet Mindfulness Questionnaire – 15 (FFMQ-15). Repetitive Negative Thinking. Timepoint: Baseline, post-treatment (week 10), 3-month follow-up, and 6-month follow-up. Method of measurement: Repetitive Thinking Questionnaire – 10-item version (RTQ-10). State-Trait Anxiety. Timepoint: Baseline, post-treatment (week 10), 3-month follow-up, and 6-month follow-up. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI). Vice-chancellor for Research and Technology, Kharazmi University Approved 2026-05-13 Ethics committee of Kharazmi University No.43, South Mofateh St, Kharazmi University, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)