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IRCT20110228005931N13 IRCT 2023-04-13 Babol University of Medical Sciences Comparing the effectiveness of web-based unified transdiagnostic treatment with specific diagnosis Comparison effectiveness of web-based unified transdiagnostic treatment versus diagnosis-specific internet psychotherapies for improvement of psychological distress in women with threatened abortion 2023-04-03 anticipated 116 Complete https://irct.ir/trial/68199 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: One hundred sixteen eligible participants will allocate randomly two groups (58 individuals) by permuted block randomization method. Group A (unified transdiagnostic treatment) and group B (diagnosis-specific) including three subgroups of depression, anxiety, and obsession will be received. The size of each block will be considered 12 using the statistical program on (seadenvelope.com). In each block, 6 times group A and 6 times group B (2 repetitions of each disorder) will be considered and produce a total of 116 sequences. In order to comply with the concealment sequence, the random list is given to a hospital staff member outside the research team who sends the codes to the principal investigator. N/A Condition 1: Depression Disorders. Condition 2: Anxiety Disorders. Condition 3: Obsession Compulsive Disorders. Intervention 1: Intervention group 1: Participants will receive web-based unified transdiagnostic treatment with a duration of 8 weeks, each session 45 minutes. The Unified protocol for transdiagnostic treatment of the emotional disorder(UP) is an emotion-focused cognitive-behavioral intervention that consists of five modules or "core" components based on elements of cognitive behavioral therapy (CBT) with proven effectiveness that address negative emotions and reactivity. It targets the negative aspects of emotions, which include learning to observe emotional experience; cognitive evaluation in creating and maintaining emotional responses, identifying behaviors affected by emotion, awareness of internal and external triggers of emotion, and learning how to prepare a hierarchy of fear and avoidance. Intervention 2: Intervention group 2: Participants will receive web-based diagnosis-specific internet psychotherapies including Internet-based cognitive behavior therapy for three disorders (depression, anxiety, and obsession-compulsion disorders) with a duration of 8 weeks, each session of 45 minutes. Specific strategies used in the protocols include the specific strategies used in the protocols included specific treatment of obsessions (types of obsessions, change of mind, confrontation and response prevention, hierarchy of anxiety, and prevention of relapse), depression: (identification and cognitive re-evaluation, negative automatic thoughts and basic beliefs, exercises to test negative beliefs, identifying schemas and changing them) and anxiety (identification and cognitive re-evaluation, cognitive errors, effective and ineffective coping strategies, behavior change, relaxation sessions). 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 The data file of the participants will be shared if allowed by the ethics committee of the university.
public Mahbobeh Faramarzi
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 47745-47176 +98 11 3219 9595 Mahbob330@yahoo.com Babol University of Medical Sciences scientific Farzan kheirkhah
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 47745-47176 +98 11 3219 9592 drfarzankh@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Education above elementary Vaginal bleeding related to pregnancy between 5 and 12 weeks Taking progesterone due to the threat of abortion Internet access Having diagnostic criteria for disorders, including depression (MDD, depression NOS), anxiety disorders (Panic disorder, Generalized anxiety disorder, Agoraphobia, Specific phobia, Social phobia, and anxiety NOS) and Obsessive-compulsive disorders based on the DSM-5 Clinical Structured Interview 18 years 45 years Female Patients with vaginal bleeding for reasons other than threatened abortion Patients who became pregnant through assisted reproductive technology Patients diagnosed as missed abortion or inevitable miscarriage and ectopic pregnancy on admission Patients without baseline ultrasound Severe psychiatric disorders and suicidal ideation Receiving other psychotherapy at the same time as this study Lack of informed consent Treatment - Other Treatment - Other Intervention group 1: Participants will receive web-based unified transdiagnostic treatment with a duration of 8 weeks, each session 45 minutes. The Unified protocol for transdiagnostic treatment of the emotional disorder(UP) is an emotion-focused cognitive-behavioral intervention that consists of five modules or "core" components based on elements of cognitive behavioral therapy (CBT) with proven effectiveness that address negative emotions and reactivity. It targets the negative aspects of emotions, which include learning to observe emotional experience; cognitive evaluation in creating and maintaining emotional responses, identifying behaviors affected by emotion, awareness of internal and external triggers of emotion, and learning how to prepare a hierarchy of fear and avoidance. Intervention group 2: Participants will receive web-based diagnosis-specific internet psychotherapies including Internet-based cognitive behavior therapy for three disorders (depression, anxiety, and obsession-compulsion disorders) with a duration of 8 weeks, each session of 45 minutes. Specific strategies used in the protocols include the specific strategies used in the protocols included specific treatment of obsessions (types of obsessions, change of mind, confrontation and response prevention, hierarchy of anxiety, and prevention of relapse), depression: (identification and cognitive re-evaluation, negative automatic thoughts and basic beliefs, exercises to test negative beliefs, identifying schemas and changing them) and anxiety (identification and cognitive re-evaluation, cognitive errors, effective and ineffective coping strategies, behavior change, relaxation sessions). Depression. Timepoint: Before intervention, after intervention (8 weeks after beginning), fallow-up of 3 month after end of intervention. Method of measurement: Edinburgh Postnatal Depression Inventor. Anxiety. Timepoint: Before the intervention, after intervention (8 weeks after beginning), fallow-up of 3 months after the end of the intervention. Method of measurement: Brief Symptoms Inventory (BSI-18). Obsession- compulsion. Timepoint: Before the intervention, after intervention (8 weeks after beginning), follow-up of 3 months after the end of the intervention. Method of measurement: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Emotion regulation. Timepoint: Before intervention, after intervention (8 weeks after beginning), fallow-up of 3 month after end of intervention. Method of measurement: Cognitive emotion regulation questionnaire (CERQ). Babol University of Medical Sciences Approved 2023-01-09 Ethic Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Babol, Iran. Babol Mazandaran Iran (Islamic Republic of)