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IRCT20250421065413N1 IRCT 2025-04-28 Iran University of Medical Sciences The Impact of Unified and Supplementary Protocols on Emotional Disorders. Comparative Effectiveness of Unified Protocol with and without Supplementary Protocol on Personality Dimensions and Symptoms in Patients with Emotional Disorders and Identifying Mechanisms of Change. 2025-04-26 anticipated 20 Complete https://irct.ir/trial/82997 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: To ensure the absence of medication interference with the research outcomes, the following conditions are mandatory: Participants who are currently taking medication must have maintained a stable dosage for a minimum of six weeks prior to study enrollment and throughout the treatment period. Individuals who are not taking medication at the time of study enrollment must not initiate any new psychotropic medication during the study period, spanning from the fulfillment of inclusion criteria until the completion of treatment. Considering that the participants will exhibit clinically significant symptoms, the non-initiation of new psychotropic medication or any alteration in the dosage or type of current medication (under psychiatric supervision) during the study duration is a prerequisite for both study entry and continued participation. Due to ethical considerations (the infeasibility of allocating patients to a wait-list control group for a duration of 5 to 6 months), this study will comprise two experimental groups, with each group receiving 16 sessions of individual psychotherapy:First experimental group (n=10): Recipients of the Unified Protocol (UP) with a focus on negative emotion regulation.Second experimental group (n=10): Recipients of a combination of the Unified Protocol and a supplementary protocol, where, in addition to the focus on negative emotion regulation, the enhancement of positive emotions is also incorporated. N/A Emotional Disorders. Intervention 1: Intervention group: The Unified Protocol (UP) is a cognitive-behavioral therapy approach that applies the same therapeutic principles, without adapting the protocol to specific disorders, to address a broad range of anxiety and depressive states in emotional disorders. It is an intervention recently developed with the aim of directly impacting neurotic temperament for the transdiagnostic treatment of emotional disorders. In this study, the Unified Protocol, authored by Barlow and colleagues at Boston University as a transdiagnostic treatment for emotional disorders, will be used for 11 sessions in the first group and 16 sessions in the second group. Intervention 2: Intervention group: The supplementary protocol is a proposed intervention aimed at engaging positive emotions. This protocol is designed as an adjunctive intervention for individuals with emotional disorders who have residual symptoms after a period focused on neuroticism (i.e., UP) and score low on the extraversion dimension. In this study, the supplementary protocol, authored by Carl, Gallagher, and Barlow at Boston University as a transdiagnostic and adjunctive treatment to the UP designed to regulate positive emotions, will be used in the final 4 sessions of the first group after receiving 11 UP sessions. Yes - There is a plan to make this available What will be shared: Outcome-related data (data from questionnaires completed by subjects) is shareable after anonymization. When: Access period starts one year after publication of results. To whom: Researchers affiliated with academic and scientific institutions. Conditions: Non-commercial use of data is permitted only. Where to obtain: Researchers can submit their data requests to the following email address: mahbubeh.fallah.fm@gmail.com (Mahboube Fallah). How to obtain: Researchers must specify the intended use of the data in their email. If the stated purposes comply with the data sharing terms, the data will be sent to the applicant's email address within one month. Comments:
public Mahbube Fallah
Iran University of Medical Sciences (IUMS),Adjacent to Milad Tower, Shahid Hemmat Highway.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 2030 mahbubeh.faاlah.fm@gmail.com Iran University of Medical Sciences scientific Mahbube Fallah
Iran University of Medical Sciences (IUMS),Adjacent to Milad Tower, Shahid Hemmat Highway.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 2030 mahbubeh.faاlah.fm@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age range between 25 and 45 years educational level of high school diploma or higher if taking medication, the dosage must have remained stable for at least 6 weeks prior to entering treatment 25 years 45 years Both Changes in medication or dosage during treatment Substance or alcohol dependence Full criteria for personality disorders Presence of psychotic disorders (such as schizophrenia or bipolar disorder) or Diagnosis of major depressive disorder with psychotic features Need for urgent treatment, such as acute suicidal ideation Concurrent treatments that may interfere with the research process Receiving psychotherapy for depression or anxiety within the past six months Symptoms due to medical conditions Treatment - Other Treatment - Other Intervention group: The Unified Protocol (UP) is a cognitive-behavioral therapy approach that applies the same therapeutic principles, without adapting the protocol to specific disorders, to address a broad range of anxiety and depressive states in emotional disorders. It is an intervention recently developed with the aim of directly impacting neurotic temperament for the transdiagnostic treatment of emotional disorders. In this study, the Unified Protocol, authored by Barlow and colleagues at Boston University as a transdiagnostic treatment for emotional disorders, will be used for 11 sessions in the first group and 16 sessions in the second group. Intervention group: The supplementary protocol is a proposed intervention aimed at engaging positive emotions. This protocol is designed as an adjunctive intervention for individuals with emotional disorders who have residual symptoms after a period focused on neuroticism (i.e., UP) and score low on the extraversion dimension. In this study, the supplementary protocol, authored by Carl, Gallagher, and Barlow at Boston University as a transdiagnostic and adjunctive treatment to the UP designed to regulate positive emotions, will be used in the final 4 sessions of the first group after receiving 11 UP sessions. Emotional Disorders: Three primary characteristics define emotional disorders: a) the intense and frequent experience of negative emotions; b) aversive reactivity towards emotional experiences due to a reduced sense of control and negative self-evaluation; c) the individual's engagement in efforts to reduce, escape, or avoid emotional experiences by developing behaviors and strategies aimed at preventing these experiences. These three criteria, through their collaboration and interaction, help to define and identify emotional disorders, which are predominantly manifested as anxiety and depressed mood states. Timepoint: 1.Pre-test 2.Mid-test (end of the eleventh week) 3.Post-test (treatment completion) 4.Follow-up (two months after treatment completion). Method of measurement: The score obtained by the participant on the Hospital Anxiety and Depression Scale (HADS). A clinical cut-off point of 6 in the 80th percentile was considered the criterion for the depression and anxiety subscales, with scores above this indicating a higher severity of depression and anxiety. Neuroticism: A personality trait defined by a tendency towards negative emotionality and a strong negative emotional response to various stressors. Individuals with this trait often tend to experience a range of negative emotions such as anxiety, fear, irritability, anger, and sadness. Furthermore, a distinguishing characteristic is a deep-rooted belief that leads them to perceive the world as a dangerous place, which in turn intensifies their negative emotions in response to stressors. Timepoint: 1.Pre-test 2.Mid-test (end of the eleventh week) 3.Post-test (treatment completion) 4.Follow-up (two months after treatment completion). Method of measurement: The score obtained by the participant on the neuroticism dimension of the Eysenck Personality Questionnaire-Revised Short Form (EPQR-S). Aversive Reactivity: A functional mechanism that acts as a bridge between the personality trait of neuroticism and the development and maintenance of emotional disorders. Timepoint: 1.Pre-test 2.Mid-test (end of the eleventh week) 3.Post-test (treatment completion) 4.Follow-up (two months after treatment completion). Method of measurement: The score obtained by the participant on the subscales of questionnaires assessing motivation and responsiveness to reward and punishment, and emotional beliefs. Extraversion: A personality trait defined by sociability, talkativeness, warmth, assertiveness, activity, and excitement-seeking, and overall the experience of positive affect. Deficits in extraversion, meaning both low and high levels of this trait, are associated with various psychopathological conditions. Timepoint: 1.Pre-test 2.Mid-test (end of the eleventh week) 3.Post-test (treatment completion) 4.Follow-up (two months after treatment completion). Method of measurement: The score obtained by the participant on the extraversion dimension of the Eysenck Personality Questionnaire-Revised Short Form (EPQR-S). Sensitivity to Reward/Rejection: A proposed functional mechanism that acts as a bridge between the personality trait of extraversion and the development and maintenance of emotional disorders. Timepoint: 1.Pre-test 2.Mid-test (end of the eleventh week) 3.Post-test (treatment completion) 4.Follow-up (two months after treatment completion). Method of measurement: The score obtained by the participant on the subscales of questionnaires assessing motivation and responsiveness to reward and punishment, and emotional beliefs. Iran University of Medical Sciences (IUMS) Approved 2024-05-13 Research Committees of Iran University of Medical Sciences Office of the Vice Chancellor for Research and Technology, Headquarters Building, Iran University of Medical Sciences (IUMS), Adjacent to Milad Tower, Hemmat Expressway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)