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IRCT20210428051113N1 IRCT 2021-06-14 Zanjan University of Medical Sciences The Effect of Cognitive Behavior therapy on Emotion Control, Repetitive Annoying Thought, Adjusting in Adolescents With Mild to moderate Symptoms of Anxiety and Depression Efficacy of Transdiagnostic Cognitive Behavior therapy on Emotion Regulation, Repetitive Negative Thought, Social Adjusting in Adolescents With Sub-clinical Diagnostic of Emotional Disorders 2021-06-29 anticipated 40 Complete https://irct.ir/trial/55900 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization will be done using Excel software. halve the number of participants and enter in tow columns 1 and 2. in the second column, we generate a random number using the Rand function option; then we sort the data by their values(ascending or descending). according to the order of numbers 1 and 2, the samples are randomly assigned to two groups. N/A Condition 1: Major depressive disorder, single episode. Condition 2: Major depressive disorder, recurrent. Condition 3: Persistent mood [affective] disorders. Condition 4: Social phobias. Condition 5: Panic disorder. Condition 6: Generalized anxiety disorder. Condition 7: Other mixed anxiety disorders. Condition 8: Mixed anxiety and depressive disorder. Intervention 1: Intervention group: The intervention group will be implemented based on an integrated transdiagnostic treatment protocol for adolescents. This protocol has 8 modals that will be implemented in 12 sessions. Protocol modalities include 1) Motivating and maintaining it 2) Identifying emotions and behaviors 3) Introducing emotion-focused behavioral experiments 4) Awareness of bodily senses 5) Flexibility in thinking 6) Awareness of emotional experiences 7) Facing situational emotions 8) Review skills and progress towards goals and maintain achievements. The main focus of the protocol is on emotion and its three basic components, namely thoughts, body senses and behavior. In the thought component, the focus on teaching mental errors is cognitive reconstruction. In the component of bodily senses, techniques of awareness of bodily senses are performed. In the behavior component, the concepts of driver and contrasting behavior are taught. Finally, situational emotion coping techniques and behavioral experiments will be performed. The modals will run for 8 sessions of 45 minutes for approximately 5 weeks. Depending on the age of the client and his / her understanding of the concepts and problems related to preclinical symptoms of emotional disorder that are unique to each client, these modals will be distributed in the sessions and the participation of parents will be determined if necessary. Intervention 2: Control group: Members of the control group will be evaluated in three periods without receiving any intervention. During this time, they should not seek psychological treatment or medication for their symptoms. The evaluation period for the members of this group lasted four months according to the quarterly follow-up period. 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 Because no intervention has been made yet and the quality of the data is still unknown.
public Dr Mohsen Dadashi
Ark Town, Beheshti Hospital
Zanjan Iran (Islamic Republic of) 1578845136 +98 24 3354 4001 psy.mohsen@gmail.com Zanjan University of Medical Sciences scientific Dr Elnaz Mousavi
Shahid Arabi St, Yemen St, Chamran Highway.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 Elnaz48.mousavi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Presence of sub-clinical symptoms of anxiety and depression Age range 12 to 17 years Participants' interest in participating in the research on the provisions of written consent 12 years 17 years Both Existence of drug or alcohol addiction Existence of chronic medical disease Having severe psychiatric disorders(psychotic spectrum, bipolar disorders) Receive medication one month before starting treatment Receive cognitive-behavioral interventions for at least 8 sessions in the last 5 years F32 F33 F34 F40.1 F41.0 F41.1 F41.3 F41.2 Major depressive disorder, single episode Major depressive disorder, recurrent Persistent mood [affective] disorders Social phobias Panic disorder [episodic paroxysmal anxiety] without agoraphobia Generalized anxiety disorder Other mixed anxiety disorders Mixed anxiety and depressive disorder Treatment - Other Treatment - Other Intervention group: The intervention group will be implemented based on an integrated transdiagnostic treatment protocol for adolescents. This protocol has 8 modals that will be implemented in 12 sessions. Protocol modalities include 1) Motivating and maintaining it 2) Identifying emotions and behaviors 3) Introducing emotion-focused behavioral experiments 4) Awareness of bodily senses 5) Flexibility in thinking 6) Awareness of emotional experiences 7) Facing situational emotions 8) Review skills and progress towards goals and maintain achievements. The main focus of the protocol is on emotion and its three basic components, namely thoughts, body senses and behavior. In the thought component, the focus on teaching mental errors is cognitive reconstruction. In the component of bodily senses, techniques of awareness of bodily senses are performed. In the behavior component, the concepts of driver and contrasting behavior are taught. Finally, situational emotion coping techniques and behavioral experiments will be performed. The modals will run for 8 sessions of 45 minutes for approximately 5 weeks. Depending on the age of the client and his / her understanding of the concepts and problems related to preclinical symptoms of emotional disorder that are unique to each client, these modals will be distributed in the sessions and the participation of parents will be determined if necessary. Control group: Members of the control group will be evaluated in three periods without receiving any intervention. During this time, they should not seek psychological treatment or medication for their symptoms. The evaluation period for the members of this group lasted four months according to the quarterly follow-up period. Sub-clinical symptoms of anxiety and depression mean that the necessary criteria for depressive or anxiety disorders are not met, and only symptoms of anxiety and depression that are in the mild to moderate range. Timepoint: Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later. Method of measurement: For the anxiety and depression variable, the 21 _DASS questionnaire will be used. The subject's score in the range of 14-18 for anxiety and 10 to 20 for depression indicates the presence of sub-clinical symptoms of anxiety and depression. Emotion regulation, which means the ability to reduce, increase or modify emotions. Timepoint: Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later. Method of measurement: The Cognitive Emotion Regulation Questionnaire (CERQ) will be used to measure emotion regulation. This questionnaire has 36 items. Repetitive negative thoughts whose main characteristic is repetitive, annoying and unwanted. Timepoint: Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later. Method of measurement: A negative recurring thoughts questionnaire (RTQ_10) will be used to measure this variable. This questionnaire has 10 items. Social adjustment means the ability to adapt and compromise with oneself, the environment and others. Timepoint: Measurements will be performed in three periods one period before the start of the intervention, 7 days later and 3 months later. Method of measurement: The Bell Social Adjustment Questionnaire will be used to measure this variable. This questionnaire has 32 items. Cognitive Flexibility. Timepoint: Before the intervention, 14 days and 3 months after the intervention. Method of measurement: Questionnaire of psychological flexibility or acceptance of action with 7 questions (AAQ) Acceptance and Action Questionnaire. Stress Vulnerability. Timepoint: Before the intervention, 14 days and 3 months after the intervention. Method of measurement: 7 Stress Questions Out of 21 questions in the Depression, Anxiety and Stress Questionnaire (DASS). Zanjan University of Medical Sciences Approved 2021-05-27 Research Ethics Committee of Zanjan University of Medical Sciences Karmandan town, Mahdavi Avenu, Zanjan university and Medical Science Zanjan Zanjan Iran (Islamic Republic of)