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IRCT20130904014564N2 IRCT 2025-09-04 Vice-chancellor for Research and Technology, Kharazmi University Mindfulness based on ‎Meta-Inner Humor MMIH Protocol Randomized Controlled Trial of a Novel Mindfulness based on ‎Meta-Inner Humor for Co-occurrence of Anxiety, OCD, and Depressive Disorders 2024-07-03 anticipated 101 Complete https://irct.ir/trial/84624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be stratified based on diagnosis severity (high/low) and gender, and will then be randomized using permuted block randomization (block size = 6). Randomization will be implemented through an independent and concealed sequence using the REDCap randomizer with a full audit trail. Group assignment will be double-blinded for both outcome assessors and participants. After confirming eligibility, participants will be randomly assigned to one of three study arms: Experimental group (MMIH intervention; n = 31), Placebo-control group (n = 31), and Waitlist control group (n = 31). An independent researcher, not involved in participant recruitment or intervention, will generate the randomization sequence and will oversee allocation concealment using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE). Researchers responsible for outcome assessment and statistical analysis will remain blinded to group assignments, Blinding description: While participants will be blinded to intervention type, outcome assessors will remain blind to group allocation. Therapists and facilitators will be instructed to avoid disclosing any information related to group identity. Participants will be informed that they may receive one of three structured interventions as part of a mental health trial. 3 Condition 1: Generalized Anxiety Disorder. Condition 2: Social Anxiety Disorder. Condition 3: Panic Disorder‎. Condition 4: Specific Phobia. Condition 5: Major Depressive Disorder. Condition 6: Dysthymia. Condition 7: Obsessive-compulsive disorder‎. Condition 8: Body dysmorphic disorder‎. Condition 9: Hoarding disorder. Intervention 1: Intervention group: Mindfulness based on Meta-Inner Humor. Intervention 2: Intervention group: Placebo-Control Intervention (Attention-Matched Psychoeducational Control)‎. Intervention 3: Control group: Waitlist control group. 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) ‎(a) Meeting DSM-5 diagnostic criteria for at least one ‎disorder in each of the following ‎categories—anxiety disorders, depressive disorders, and ‎obsessive-compulsive and related ‎disorders—as determined by the Structured Clinical Interview ‎for DSM-5 (SCID-5); (b) Age 18 ‎years or older; (c) Provision of written informed consent. ‎ 18 years 70 years Both Exclusion criteria were: (a) ‎current or past diagnosis of psychotic disorders, bipolar ‎disorders, severe personality disorders, ‎substance use disorders, or any debilitating medical ‎condition (e.g., uncontrolled chronic ‎illness); (b) Current suicidality. Use of stable pharmacotherapy (e.g., SSRIs, SNRIs, ‎benzodiazepines) was permitted if dosage remained unchanged during the six months prior to ‎enrollment and throughout the intervention.‎ F41.1 F40.1 F41.0 F40.2 F32 F34.1 F42 F45.22 Generalized anxiety disorder Social phobias Panic disorder [episodic paroxysmal anxiety] without agoraphobia Specific (isolated) phobias Major depressive disorder, single episode Dysthymic disorder Obsessive-compulsive disorder Body dysmorphic disorder Behavior Placebo Other Intervention group: Mindfulness based on Meta-Inner Humor Intervention group: Placebo-Control Intervention (Attention-Matched Psychoeducational Control)‎ Control group: Waitlist control group Obsessive compulsive symptoms. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and at 6-month follow-up‎. Method of measurement: The Obsessive-Compulsive Inventory-Revised (OCI-R)‎. Depressive symptom. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and at 6-month follow-up‎. Method of measurement: Patient Health Questionnaire–9 (PHQ-9)‎. Trait anxiety ‎. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and at 6-month follow-up‎. Method of measurement: State-Trait Anxiety Inventory (STAI)‎. Life satisfaction‎. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and at 6-month follow-up‎. Method of measurement: Satisfaction with Life Scale (SWLS)‎. Mindfulness. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and a six-month follow-up‎. Method of measurement: The Mindfulness Attention Awareness Scale (MAAS)‎. Psychological inflexibility. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and a six-month follow-up‎. Method of measurement: Acceptance and Action Questionnaire–II (AAQ-II)‎. Repetitive negative thoughts. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and a six-month follow-up‎. Method of measurement: Repetitive Thinking Questionnaire–10 (RTQ-10)‎. Positive and negative metacognitions. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and a six-month follow-up‎. Method of measurement: Metacognitions Questionnaire–30 (MCQ-30)‎. Self-Compassion. Timepoint: Pre-treatment (baseline), post-treatment (end of week 10), and a six-month follow-up‎. Method of measurement: Self-Compassion Scale–Short Form (SCS-SF)‎. Vice-chancellor for Research and Technology, Kharazmi University Approved 2025-08-31 Ethics committee of Kharazmi University No.43, South Mofateh St, Kharazmi University, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)