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IRCT20250530065973N1 IRCT 2025-06-20 University of Kurdistan The Effectiveness of the Unified for Transdiagnostic Treatment on Health Anxiety Comorbid with other Emotional Disorder The Effectiveness of the Unified Protocol for Transdiagnostic Treatment on Symptoms and Psychological Indicators of University Students with Health Anxiety Comorbid with Other Emotional Disorders: A Randomized Controlled Trial 2025-06-26 anticipated 32 Complete https://irct.ir/trial/84077 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selection based on the inclusion and exclusion criteria, participants will be assigned to the treatment and control groups using the minimization method. This approach ensures balanced distribution of gender across groups: for instance, if the first participant is female, she will be placed in the first group. If the second participant is male, he will also be placed in the first group. Conversely If the third participant is female, she will be placed in the second group. This process continues to ensure gender variables are evenly distributed between the groups, Blinding description: In this study, clinical interviews to assess inclusion and exclusion criteria will be conducted by a licensed clinical psychologist. After providing full information about the aims and procedures of the study, written informed consent will be obtained from all participants. Participants will be randomly assigned to intervention and control groups by an independent individual who will not be involved in treatment or assessments. They will be blinded to their group assignment and will only be informed about the general purpose of the study. The treating clinician will also remain unaware of group allocation, and the intervention sessions will be delivered without knowledge of whether the participant is in the intervention or control group.Outcome assessments at pre-test, post-test, and one-month follow-up, as well as data analysis, will be conducted by independent researchers who will be blinded to group allocation. Therefore, blinding will be implemented at the levels of participants, clinical provider, and outcome assessors/data analysts, and all ethical standards for human subject research will be fully respected. N/A Health Anxiety. Intervention 1: Intervention group: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders consists of up to twelve 45-minute sessions. This treatment targets and modifies emotional experiences through enhancing emotional awareness and cognitive flexibility, identifying and replacing maladaptive emotional behaviors with more adaptive ones, recognizing and preventing emotional avoidance, increasing awareness of and exposure to physical sensations, and facilitating emotional exposure in relevant situations. Intervention 2: Control group: The control group will be placed on a waiting list to receive the Unified Transdiagnostic Treatment. After the completion of the follow-up sessions for the intervention groups, the same treatment protocol will be offered to the control group, identical to the one provided to the initial intervention group. Yes - There is a plan to make this available What will be shared: A portion of the data, including information related to the primary outcome, is available for sharing. When: Data access will be granted one year following the publication of the study results. To whom: The data will be available only to researchers affiliated with academic institutions. Conditions: Requests for data use are permitted only for cross-cultural research or meta-analytic studies. Where to obtain: Researchers may request the relevant documents or data by contacting the following email address: nasiri.uok@yahoo.com How to obtain: Data will be provided via email or in person after the request has been reviewed and approved. Comments:
public Elham Fathi
Pasdaran Boulevard, University of Kurdistan
Sanandaj Iran (Islamic Republic of) 66177-15175 +98 87 3872 1255 lham.fathi1@gmail.com University of Kurdistan scientific Farzad Nasiri
pasdaran Boulevard, University of Kurdistan
Sanandaj Iran (Islamic Republic of) 66177-15175 087-33664601-2246 nasiri.uok@yahoo.com University of Kurdistan Iran (Islamic Republic of) The Diagnosis of Health Anxiety Disorder is based a Clinical Interview and the Health Anxiety Questionnaire. Having at least one Emotional Disorder. Providing informed consent to participate in the study. The ability to speak Persian. Participants must be at least 18 years old. 18 years 40 years Both Receiving concurrent psychological treatment. Having other psychiatric disorder. The need for pharmacological intervention. Being absent from more than two therapy sessions. F45.2 Hypochondriacal disorders Treatment - Other Treatment - Other Intervention group: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders consists of up to twelve 45-minute sessions. This treatment targets and modifies emotional experiences through enhancing emotional awareness and cognitive flexibility, identifying and replacing maladaptive emotional behaviors with more adaptive ones, recognizing and preventing emotional avoidance, increasing awareness of and exposure to physical sensations, and facilitating emotional exposure in relevant situations. Control group: The control group will be placed on a waiting list to receive the Unified Transdiagnostic Treatment. After the completion of the follow-up sessions for the intervention groups, the same treatment protocol will be offered to the control group, identical to the one provided to the initial intervention group. Health Anxiety. Timepoint: pre_ Treatment, post_ Treatment, and one_ month Follow_ up. Method of measurement: Salkovskis et al. Health Anxiety Questionnaire. Dpression. Timepoint: pre_ Treatment, post_ Treatment, and one_ month Follow_ up. Method of measurement: Beck Depression Inventory(BDI). Anxiety. Timepoint: pre_ Treatment, post_ Treatment, and one_ month Follow_ up. Method of measurement: Beck Anxiety Inventory(BAI). Distress Tolerance. Timepoint: pre_ Treatment, post_ Treatment, and one_ month Follow_. Method of measurement: Distres‌s and Tolerance Scale (DTS) by simons and Gaher. Experiential Avoidance. Timepoint: pre_ Treatment, post_ Treatment, and one_ month Follow_. Method of measurement: Gamez Eexperiential Questionnare (EAAQ). Rumination. Timepoint: pre_ Treatment, post_ Treatment, and one_ month Follow_. Method of measurement: Ruminative Responses Scale(RRS) Nolen_ Hoeksema. Body Awareness. Timepoint: pre_ Treatment, post_ Treatment, and one_ month Follow_. Method of measurement: Body Awareness Questionnaire (BAQ) by shields et al. University of Kurdistan Approved 2025-05-17 Ethics Committee for Biomedical Research University of Kurdistan Pasdaran Boulevard, University of Kurdistan, Central Administration Sanandaj Kurdistan Iran (Islamic Republic of)