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IRCT20170104031765N2 IRCT 2023-11-14 Iran University of Medical Sciences Comparison of the Effectiveness of the Unified Protocol for Transdiagnostic Treatment and Cognitive Behavioral Therapy (CBT) in Improving Severe Health Anxiety Comparison of the Effectiveness of the Unified Protocol for Transdiagnostic Treatment (UP) and Cognitive Behavioral Therapy (CBT) on Emotional, Behavioral and Cognitive Components in Patients with Illness Anxiety Disorder Comorbid with Depression 2023-11-22 anticipated 50 Complete https://irct.ir/trial/71805 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 50 people are selected according to similar research, in an accessible way. Then random replacement is done by lottery method (one number will be assigned to each sample person). We write down the numbers on paper, fold them and put them in a container. We mix and stir the papers completely. Then we take out the papers one by one and put one number in the first group and one number in the second group. Then random application will be done. In this way, one group is known as "cognitive behavioral therapy group" and the other group is known as "Unified transdiagnostic therapy group". The lottery will be done by putting the two groups obtained from the previous step (random replacement step) into two separate envelopes and placing them in a container. Then we randomly take one envelope out of the container and assign it to the "Unified transdiagnostic treatment group" and the other envelope to the "cognitive behavioral therapy group", Blinding description: Our study will be conducted in a double-blind manner, which means that the type of treatment was unknown to the patients and the data analyst. Participants will not know the group type. Also, at first, they will be unaware of which group they belong to. The questionnaires will be completed under the supervision of an individual unaware of the research objectives. N/A illness anxiety disorder. Intervention 1: Intervention group: the people of the experimental group or integrated meta-diagnostic therapy group during 12 group sessions of approximately 60 to 90 minutes. All sections are performed on the subjects in a fixed order and with equal sessions. The sessions of this treatment protocol include the first session: increasing motivation; The second session: Providing psychological training; The third and fourth sessions: Emotional awareness training; The fifth session: cognitive reassessment; The sixth session: Identifying avoidance patterns; the Seventh session: Emotion-induced behaviors (EDBs); Eighth session: awareness and tolerance of physical feelings; 9th and 11th sessions: introception and situational expouser and 12th session: relapse prevention. Treatment sessions will also be offered to clients by targeting treatment goals and focusing on different parts of the protocol. Intervention 2: Control group: Patients assigned to the control group receive the treatment protocol called "cognitive-behavioral therapy for illness anxiety". This protocol consists of 12 weekly sessions for 60-90 minutes, and was designed by Axelsson in 2020 based on the cognitive-behavioral model. The content of the cognitive-behavioral therapy sessions is as follows. The first session: Introduction to CBT and health anxiety. Second session: The CBT model of health anxiety. The third session: Interoceptive exposure. Fourth session: Response prevention. Fifth session: Exposure in vivo. The sixth session: Imaginal exposure. Seventh session: Continued imaginal exposure and the fear of death. Eighth session: Common obstacles to exposure. 9th and 10th session: Continued exposure and response prevention. The eleventh session: summary and values. Session 12: Continuous improvement and healthcare utilization. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamid Mohsenabadi
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 mohsenabadi.h@iums.ac.ir Iran University of Medical Sciences scientific Mohammadreza Pirmoradi
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6650 9024 pirmoradi.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Primary diagnosis of illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) Diagnosis of major depressive disorder (MDD), persistent depressive disorder (PDD) based on DSM-5 criteria Ages 18 to 65 years Able to read and write Not taking psychiatric drugs or in the case of taking antidepressants and anti-anxiety drugs for at least two months before the onset of interventions, the drug dose must be constant and the patient must agree to the drug dose remaining constant during the study 18 years 65 years Both Patients with psychotic disorders Patients with bipolar disorder Patients with depressive disorder with psychotic symptoms Patients with a history of drug use in the last 6 months Patients at risk of suicide Personality disorder making the treatment procedure very difficult Patients with eating disorders Having a history of incurable physical illness such as cancer The need to change, stop or increase the drug dose or start a new drug after pre-test evaluations Receiving other psychological treatments in the past 5 years F45.2 Hypochondriacal disorders Treatment - Other Treatment - Other Intervention group: the people of the experimental group or integrated meta-diagnostic therapy group during 12 group sessions of approximately 60 to 90 minutes. All sections are performed on the subjects in a fixed order and with equal sessions. The sessions of this treatment protocol include the first session: increasing motivation; The second session: Providing psychological training; The third and fourth sessions: Emotional awareness training; The fifth session: cognitive reassessment; The sixth session: Identifying avoidance patterns; the Seventh session: Emotion-induced behaviors (EDBs); Eighth session: awareness and tolerance of physical feelings; 9th and 11th sessions: introception and situational expouser and 12th session: relapse prevention. Treatment sessions will also be offered to clients by targeting treatment goals and focusing on different parts of the protocol. Control group: Patients assigned to the control group receive the treatment protocol called "cognitive-behavioral therapy for illness anxiety". This protocol consists of 12 weekly sessions for 60-90 minutes, and was designed by Axelsson in 2020 based on the cognitive-behavioral model. The content of the cognitive-behavioral therapy sessions is as follows. The first session: Introduction to CBT and health anxiety. Second session: The CBT model of health anxiety. The third session: Interoceptive exposure. Fourth session: Response prevention. Fifth session: Exposure in vivo. The sixth session: Imaginal exposure. Seventh session: Continued imaginal exposure and the fear of death. Eighth session: Common obstacles to exposure. 9th and 10th session: Continued exposure and response prevention. The eleventh session: summary and values. Session 12: Continuous improvement and healthcare utilization. Health anxiety score in Salkowski questionnaire. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Health Anxiety Questionnaire - Short Form (SV-HAI). Depression score in Beck questionnaire. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Beck Depression Inventory - Second Edition (BDI-II). The score of cognitions related to health anxiety. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Health Cognition Questionnaire (HCQ). Anxiety Sensitivity Score. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Anxiety sensitivity index-3 (ASI-3). Distress Tolerance Score. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Distress Tolerance Scale (DTS). Emotion Regulation Score. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Emotion regulation Questionnaire (ERQ). Beck anxiety score. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Beck Anxiety Inventory (BAI). Cyberchondria Score. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Short-Form- Cyberchondria Severity Scale (12-CSS). Score different aspects of illness behavior. Timepoint: Before and after interventions and three month follow-up. Method of measurement: The Scale for the Assessment of Illness Behaviour (SAIB). Interoceptive Attention Score. Timepoint: Before and after interventions and three month follow-up. Method of measurement: Interoceptive Attention Scale. Amount of credibility/expectancy of improvement. Timepoint: After interventions. Method of measurement: Credibility/Expectancy Questionnaire (CEQ). The rate of therapeutic alliance. Timepoint: After interventions. Method of measurement: Working Alliance Inventory (WAI) For assessing therapeutic alliance. Iran University of Medical Sciences Approved 2023-11-12 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)