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IRCT20251116068014N1 IRCT 2025-11-19 Rose White Chain Clinics (affiliated with Imam Khomeini Relief Foundation) Examining the Effect of a Culturally Adapted Subliminal Stimulation Protocol on Suicidal Ideation in Adolescents Neurocognitive and Clinical Effects of a Culturally Adapted Subliminal Auditory Intervention Integrating Mindfulness and Existential Components on Suicidal Ideation in Adolescents 2025-11-22 anticipated 600 Complete https://irct.ir/trial/87537 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. Randomization Method: This study employs cluster randomization, in which psychological clinics across Iran are considered clusters and are randomly assigned to either the Intervention group or the Control group. To maintain balance between the groups, block randomization at the cluster level will be applied. 2. Unit of Randomization: The unit of randomization is the psychological clinic. To prevent contamination between groups, all eligible adolescents within each clinic will be assigned to the same study arm. 3. Stratification Layers (if applied): This study will use stratified cluster randomization. The stratification layers include: Geographical region (north, south, east, west, central) Clinic size (low-caseload, medium-caseload, high-caseload) 4. Randomization Tools: The random allocation sequence will be generated using standard tools, including: R statistical software for computer-generated random numbers Variable block sizes to avoid predictability A researcher independent from participant recruitment will perform the randomization procedure. 5. Generation of the Random Allocation Sequence: Clinics will first be stratified based on predefined layers. A list of random numbers will then be generated using statistical software, and clinics will be assigned to blocks of 4 to 6 clusters. The allocation sequence will be generated by an independent researcher to prevent bias. 6.Allocation Concealment: To ensure proper allocation concealment: The randomization sequence will be placed in opaque, sealed, sequentially numbered envelopes. These envelopes will only be opened after the completion of baseline assessment at each clinic. The recruitment team will not have access to the allocation sequence. This method prevents prior knowledge of group assignment and reduces selection bias, Blinding description: 1. Participants: Participants are and will remain unaware of their group allocation (intervention or control). Both groups receive an audio file that is indistinguishable in terms of listening experience; therefore, participants remain blinded throughout the entire study. 2. Outcome Assessors: Outcome assessors do not and will not have access to group allocation. All data are provided to them in anonymized, coded format with no indicators of group assignment. 3. Data Collectors: Data collectors do not have access to the randomization sequence and receive all information only through participant codes. They remain blinded throughout the data collection process. 4. Principal Investigator: The principal investigator remains blinded during data collection and outcome assessment and will gain access to group allocation only after the completion of all analyses. Blinding of the principal investigator is maintained during the analysis phase. 5. Clinical Staff: Clinical staff who deliver the audio files to participants are unaware of the file type and the assigned group. Therefore, these staff members also remain blinded during the study procedures. 6. Data Safety and Monitoring Committee (DSMC): The DSMC has access only to coded, anonymized datasets. Unblinding occurs solely in the event of a serious safety concern. 7. Data Analysts and Manuscript Writers: Data analysts and manuscript authors work with fully de-identified datasets and remain blinded to group allocation until the completion of statistical analyses. Unblinding is performed only after the analysis is finalized. N/A Suicidal ideation, Rumination, Anhedonia, Mental health. Intervention 1: Intervention Group:Participants in the intervention group will attend 16 sessions, each lasting 45 minutes. The structure of each session is as follows:• First 15 minutes (Preparation Phase): Stabilizing the baseline state through brief relaxation, focused breathing, and attention adjustment. No direct therapeutic content is delivered in this phase.• Second 15 minutes (Core Intervention): Playback of a culturally adapted subliminal audio file based on mindfulness and existential components. Specifications of the audio file include:• Layer 1: Relaxation-based background music with a steady BPM (played at approximately 60–65 dB).• Layer 2: Therapeutic subliminal messages played below the threshold of conscious awareness (under 30 dB).• Content of subliminal messages: Brief statements targeting reductions in cognitive entrapment, rumination, emotional suppression, and enhancing acceptance, cognitive flexibility, and attentional grounding.• Playback conditions: Standard headphones, quiet setting, fixed sound level.• Final 15 minutes (Post-intervention Assessment): Participants respond to a structured set of questions capturing momentary emotional responses, perceived tension, attentional state, and subjective experience following the audio exposure. This phase is used for real-time monitoring of experiential and emotional changes. Intervention 2: Control group: Participants in the control group will attend 16 sessions, each lasting 45 minutes. The structure of each session is as follows:• First 15 minutes (Preparation): General settling-in period including brief orientation, relaxation, and adjustment of environmental conditions. No therapeutic content is provided.• Second 15 minutes (Placebo Audio): Participants listen to a neutral audio file without any subliminal messages. The file contains only soft instrumental music with fixed volume and no cognitive or emotional therapeutic content.• Final 15 minutes (Post-session Monitoring): Participants complete brief reports assessing their momentary feelings, emotional state, concentration, and subjective listening experience. No therapeutic techniques or interventions are included.This group serves as an auditory placebo, with identical duration, structure, and environmental conditions to the intervention group. Yes - There is a plan to make this available What will be shared: Title of documents: De-identified participant data, including questionnaire results (primary and secondary outcomes) Individual participant data will be shared after removal of all identifiable and personal information. Only data related to primary and secondary outcomes, including questionnaire scores at pre-test, post-test, and 3-month follow-up, will be accessible. Raw identifiable data, audio files, or any confidential information will not be shared. When: Data access will begin 6 months after publication of the study results and will remain available for 5 years following publication. To whom: Data will be available only to researchers affiliated with accredited academic or research institutions, upon formal request and review by the study’s research committee. Conditions: Conditions for data use: Data may be used only for scientific and research purposes. A defined and approved research proposal is required. Commercial use, redistribution, or sharing with third parties is prohibited. Any attempt to identify participants or restore personal information is strictly forbidden. Access will be granted only after signing a responsible data-use agreement. Where to obtain: Investigator using the information below: Name and position: Dr. Khatereh Arbabi (Principal Investigator) Address: No. 33, Rasoulian Lane, Zabeti Street, Heravi, Tehran, Iran Email: arbabikhatere@gmail.com Phone: +98 912 224 3889 Requests will be accepted only via email or formal written communication and data access will be granted after review by the Principal Investigator and approval of the research committee. How to obtain: Process for Requesting and Receiving Data: Submit a formal request to the principal investigator’s email, including a brief description of the proposed research. Initial review of the request by the principal investigator (within approximately 2 weeks). Submission of the full proposal, a data-use commitment form, and documentation of institutional affiliation. Final review and approval by the research committee (within approximately 2–4 weeks). Upon approval, de-identified data will be shared with the applicant through a secure transfer method.Estimated total time for the process: 4–6 weeks. Comments:
public khatereh Arbabi
No. 33, Rasoulian Lane, Zabeti Street, Heravi, Tehran Town
Tehran Iran (Islamic Republic of) 1667838614 +98 21 2294 2918 arbabikhatere@gmail.com Rose White Chain Clinics (affiliated with Imam Khomeini Relief Foundation) scientific khatereh Arbabi
No. 33, Rasoulian Ave, Zabeti St, Heravi, Tehran Town
Tehran Iran (Islamic Republic of) 1667838614 +98 21 2294 1829 Arbabikhatere@gmail.com Rose White Chain Clinics (affiliated with Imam Khomeini Relief Foundation) Iran (Islamic Republic of) Screening for eligibility through a clinical interview (conducted by a psychotherapist) and the Beck Scale (BSSI)for Suicide Ideation (with high scores indicating elevated suicidal thoughts) is administered. 13 years 18 years Both Severe psychiatric disorders (psychosis, bipolar disorder, etc.) Acute suicide risk requiring immediate hospitalization Cognitive impairment that interferes with completing the intervention tasks Treatment - Other Placebo Intervention Group:Participants in the intervention group will attend 16 sessions, each lasting 45 minutes. The structure of each session is as follows:• First 15 minutes (Preparation Phase): Stabilizing the baseline state through brief relaxation, focused breathing, and attention adjustment. No direct therapeutic content is delivered in this phase.• Second 15 minutes (Core Intervention): Playback of a culturally adapted subliminal audio file based on mindfulness and existential components. Specifications of the audio file include:• Layer 1: Relaxation-based background music with a steady BPM (played at approximately 60–65 dB).• Layer 2: Therapeutic subliminal messages played below the threshold of conscious awareness (under 30 dB).• Content of subliminal messages: Brief statements targeting reductions in cognitive entrapment, rumination, emotional suppression, and enhancing acceptance, cognitive flexibility, and attentional grounding.• Playback conditions: Standard headphones, quiet setting, fixed sound level.• Final 15 minutes (Post-intervention Assessment): Participants respond to a structured set of questions capturing momentary emotional responses, perceived tension, attentional state, and subjective experience following the audio exposure. This phase is used for real-time monitoring of experiential and emotional changes. Control group: Participants in the control group will attend 16 sessions, each lasting 45 minutes. The structure of each session is as follows:• First 15 minutes (Preparation): General settling-in period including brief orientation, relaxation, and adjustment of environmental conditions. No therapeutic content is provided.• Second 15 minutes (Placebo Audio): Participants listen to a neutral audio file without any subliminal messages. The file contains only soft instrumental music with fixed volume and no cognitive or emotional therapeutic content.• Final 15 minutes (Post-session Monitoring): Participants complete brief reports assessing their momentary feelings, emotional state, concentration, and subjective listening experience. No therapeutic techniques or interventions are included.This group serves as an auditory placebo, with identical duration, structure, and environmental conditions to the intervention group. Primary outcome: Suicidal ideation score on the Beck Scale for Suicidal Ideation (BSSI). Timepoint: Measured at pre-test, post-test, and 3-month follow-up. Method of measurement: Beck Scale for Suicidal Ideation. Rumination score (RRS). Timepoint: Measured at pre-test, post-test, and 3-month follow-up. Method of measurement: Ruminative Responses Scale(RSS). Anhedonia score (SHAPS). Timepoint: Measured at pre-test, post-test, and 3-month follow-up. Method of measurement: Snaith–Hamilton Pleasure Scale(SHAPS). Mental health score (MHC-SF). Timepoint: Measured at pre-test, post-test, and 3-month follow-up. Method of measurement: Mental Health Continuum – Short Form(MHC-SF). Imam Khomeini Relief Foundation Approved 2025-11-16 Islamic Azad University, Qom Branch No. 33, Rasoulian Ave, Zabeti St, Heravi Area, Tehran Town Tehran Tehran Iran (Islamic Republic of)