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IRCT20251124068098N1 IRCT 2026-05-19 Islamic Azad University Comparison of Unified Transdiagnostic Treatment and Acceptance and Commitment Therapy in Patients with Functional Seizures UTFS-ACT Comparing Unified Transdiagnostic Intervention with Acceptance and Commitment Therapy on Sensory Processing Sensitivity, Interpretive Bias, and Experiential Avoidance among Individuals with Functional Seizures 2026-06-22 anticipated 45 Recruiting https://irct.ir/trial/90198 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a quasi-experimental trial with a pretest-posttest design and a three-month follow-up. Participants will be randomly assigned to three groups: Unified Transdiagnostic Treatment, Acceptance and Commitment Therapy, and a waitlist control group, Randomization description: In this study, block randomization with a 1:1:1 allocation ratio will be used. The unit of randomization is the individual participant. After confirming eligibility criteria and obtaining informed consent, participants will be randomly assigned to one of three groups: Unified Transdiagnostic Intervention, Acceptance and Commitment Therapy, or waitlist control group. The random allocation sequence will be generated using statistical software and equal-sized blocks to ensure balanced group sizes. Randomization will be performed by an independent research assistant who is not involved in outcome assessment or intervention delivery. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Group assignment will only be revealed after the participant is formally enrolled in the study. Outcome assessors will remain blinded to group allocation, Blinding description: In this study, outcome assessors and data collectors will be blinded to participants’ group allocation. Random assignment will be conducted by an independent researcher, and allocation information will be kept in sealed opaque envelopes. During the pretest, posttest, and follow-up assessments, evaluators will only have access to participants’ research codes and will remain unaware of the intervention group assignment. Data analysis will also be conducted using anonymized coded data. Due to the nature of the psychological interventions, blinding of participants and therapists is not feasible, as participants are aware of the type of treatment they receive and therapists directly administer the interventions. However, standardized instructions, structured treatment protocols, and blinded outcome assessment will be used to minimize potential bias. N/A Functional Seizure Disorder. Intervention 1: Intervention group: Participants in this group will receive Unified Transdiagnostic Intervention in 12 weekly 60 minute group sessions. The intervention includes psychoeducation about emotions, emotional awareness, mindfulness training, cognitive reappraisal, reduction of emotional avoidance, modification of emotion driven behaviors, interoceptive and situational exposure, and relapse prevention. Intervention 2: Intervention group: Participants in this group will receive Acceptance and Commitment Therapy in 8 weekly 90 minute group sessions. The intervention includes acceptance of internal experiences, mindfulness training, cognitive defusion, contact with the present moment, clarification of personal values, commitment to value based actions, and modification of maladaptive behavioral patterns. Intervention 3: Control group: Participants in this group will be placed on a waitlist and will not receive any structured psychological intervention from the research team during the study period. They will continue receiving routine medical care only. After completion of data collection, they will be offered one of the therapeutic interventions. Yes - There is a plan to make this available What will be shared: Deidentified participant data, study protocol, statistical analysis plan, informed consent form, data dictionary, and analysis codes will be available for sharing after completion of the study and removal of identifiable participant information. When: The data and documents will be available from six months after publication of the study results for a period of five years. To whom: Researchers, faculty members, graduate students, and investigators affiliated with academic and scientific institutions may request access to the data and study documents. Conditions: The data and documents may only be used for scientific, research, and educational purposes. Applicants must submit a formal request and agree to use the data solely for approved research objectives while maintaining participant confidentiality. Where to obtain: Applicants may contact the principal investigator, Ali Khademi, through the academic email address below to request access to the data and documents. Email: Ali.khademi@iau.ac.ir How to obtain: After receiving a formal request, the application will be reviewed by the principal investigator. If the research purpose is approved and confidentiality requirements are met, the requested data and documents will be provided within four weeks. Comments:
public Somayeh Tajfar
خیابان گل ها -بلوار رئوفی -کوچه گل یخ پلاک۱۳ ر
Tabriz Iran (Islamic Republic of) 1234567890 +98 41 3385 5349 somayeh.tajfar@iau.ir Islamic Azad University scientific Somayeh Tajfar
خیابان گل ها -بلوار رئوفی -کوچه گل یخ پلاک۱۳ ر
Tabriz Iran (Islamic Republic of) 1234567890 +98 41 3385 5349 somayeh.tajfar@iau.ir Islamic Azad University Iran (Islamic Republic of) Diagnosis of functional seizure disorder by a psychiatrist or neurologist Age between 18 and 55 years Stable medication regimen during the past three months Ability to read and write Persian Providing informed consent for participation 18 years 55 years Both Severe psychotic disorders Presence of severe neurological disorders Inability to participate regularly in treatment sessions Changes in psychiatric medications during the study F44.5 Conversion disorder with seizures or convulsions Behavior Behavior N/A Intervention group: Participants in this group will receive Unified Transdiagnostic Intervention in 12 weekly 60 minute group sessions. The intervention includes psychoeducation about emotions, emotional awareness, mindfulness training, cognitive reappraisal, reduction of emotional avoidance, modification of emotion driven behaviors, interoceptive and situational exposure, and relapse prevention. Intervention group: Participants in this group will receive Acceptance and Commitment Therapy in 8 weekly 90 minute group sessions. The intervention includes acceptance of internal experiences, mindfulness training, cognitive defusion, contact with the present moment, clarification of personal values, commitment to value based actions, and modification of maladaptive behavioral patterns. Control group: Participants in this group will be placed on a waitlist and will not receive any structured psychological intervention from the research team during the study period. They will continue receiving routine medical care only. After completion of data collection, they will be offered one of the therapeutic interventions. Sensory processing sensitivity score in individuals with functional seizures. Timepoint: Before the intervention, immediately after completion of the intervention, and three months after the intervention. Method of measurement: Aron and Aron Sensory Processing Sensitivity Questionnaire. Interpretive bias score in individuals with functional seizures. Timepoint: Before the intervention, immediately after completion of the intervention, and three months after the intervention. Method of measurement: Ambiguous Scenarios Test for Depression. Experiential avoidance score in individuals with functional seizures. Timepoint: Before the intervention, immediately after completion of the intervention, and three months after the intervention. Method of measurement: Multidimensional Experiential Avoidance Questionnaire. Islamic Azad University Approved 2026-04-21 Ethics Committee of Islamic Azad University, Urmia Branch Islamic Azad University, Urmia Branch, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)