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IRCT20230117057142N1 IRCT 2023-02-09 Zanjan University of Medical Sciences Comparison the effectiveness of face-to-face and online psychotherapy on mild anxiety Comparison of the efficacy of face-to-face and online Transdiagnostic therapy on anxiety severity,related transdiagnostic factors and therapeutic alliance in people with Sub-clinical symptoms of anxiety disorders 2023-03-08 anticipated 44 Complete https://irct.ir/trial/68137 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are randomly assigned to two test groups. Random allocation is done using Excel software. For this purpose, in the first column, we enter 22 numbers 1 and 22 numbers 2 (respectively indicating the group (online and face-to-face integrative meta-diagnostic treatment group). Then in the second column, we generate 44 random numbers using the RAND() function. The data Based on the column values, we include random numbers sorted (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups, Blinding description: None of the subjects will be informed about the randomization and interpretation process of the groups. N/A Condition 1: Social phobias. Condition 2: Panic disorder [episodic paroxysmal anxiety] without agoraphobia. Condition 3: Generalized anxiety disorder. Condition 4: Other mixed anxiety disorders. Condition 5: Phobic anxiety disorders. Condition 6: Agoraphobia, unspecified. Intervention 1: The first intervention group face-to-face Transdiagnostic treatment group: The intervention will be implemented face-to-face and based on the Transdiagnostic therapy (Unified protocol) for adults. This protocol has 8 modules that will be implemented in 12 sessions. The protocol modules are 1 (goal selection and maintaining motivation) 2 (understanding emotions) 3 (mindfulness of emotion) 4 (cognitive flexibility) 5 (emotional behavior) 6 (understanding and dealing with bodily sensations) 7 (facing with excitement) 8 (reviewing skills and moving towards goals and maintaining achievements). The main focus of the protocol is on emotion and its three basic components, namely thoughts, physical sensations, and behavior. In the component of thoughts, the focus is on training mental errors and cognitive restructuring. In the component of bodily sensations, the techniques of awareness of bodily sensations are implemented. In the behavior component, training on the concepts of initiation and conflicting behavior is given. Finally, coping techniques with situational emotions and behavioral tests will be performed. Modals will be implemented during 12 sessions of 45 minutes for approximately 6 weeks. These modules will be distributed in the sessions according to the client's understanding and acceptance of the concepts and problems related to the preclinical symptoms of anxiety disorder, which is unique for each client. Intervention 2: The second intervention group, the online Transdiagnostic treatment group: the intervention will be implemented online and based on the Transdiagnostic therapy (Unified protocol) for adults.This protocol has 8 modules that will be implemented in 12 sessions. The protocol modules are 1 (goal selection and maintaining motivation) 2 (understanding emotions) 3 (mindfulness of emotion) 4 (cognitive flexibility) 5 (emotional behavior) 6 (understanding and dealing with bodily sensations) 7 (facing with excitement) 8 (reviewing skills and moving towards goals and maintaining achievements). The main focus of the protocol is on emotion and its three basic components, namely thoughts, physical sensations, and behavior. In the component of thoughts, the focus is on training mental errors and cognitive restructuring. In the component of bodily sensations, the techniques of awareness of bodily sensations are implemented. In the behavior component, training on the concepts of initiation and conflicting behavior is given. Finally, coping techniques with situational emotions and behavioral tests will be performed. Modals will be implemented during 12 sessions of 45 minutes for approximately 6 weeks. These modules will be distributed in the sessions according to the client's understanding and acceptance of the concepts and problems related to the preclinical symptoms of anxiety disorder, which is unique for each client. 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 zeinab hasanpour pirbasti
Ark Gate ,Dr. Beheshti Hospital
zanjan Iran (Islamic Republic of) 1578845136 +98 24 3354 4001 zeinabhassanpour78@gmail.com Zanjan University of Medical Sciences scientific zeinab hasanpour pirbasti
Ark Gate, Dr. Beheshti Hospital
zanjan Iran (Islamic Republic of) 1578845136 +98 24 3354 4001 zeinabhassanpour78@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) having subclinical anxiety symptoms based on Beck's anxiety questionnaire (scoring 8-25) age range between 18-50 years not suffering from severe psychiatric disorders (psychotic spectrum, bipolar disorder) not consuming drugs and alcohol in the last three months Not receiving cognitive-behavioral interventions for at least eight sessions in the last five years not receiving drug therapy within a month before the start of the intervention the interest of the participants to participate in the research based on the provisions of the written consent 18 years 50 years Both Having drug or alcohol addiction suffering from severe psychiatric disorders (schizophrenia and bipolar disorder) F40.1 F41.0 F41.1 F41.3 F40 F40.00 Social phobias Panic disorder [episodic paroxysmal anxiety] without agoraphobia Generalized anxiety disorder Other mixed anxiety disorders Phobic anxiety disorders Agoraphobia, unspecified Treatment - Other Treatment - Other The first intervention group face-to-face Transdiagnostic treatment group: The intervention will be implemented face-to-face and based on the Transdiagnostic therapy (Unified protocol) for adults. This protocol has 8 modules that will be implemented in 12 sessions. The protocol modules are 1 (goal selection and maintaining motivation) 2 (understanding emotions) 3 (mindfulness of emotion) 4 (cognitive flexibility) 5 (emotional behavior) 6 (understanding and dealing with bodily sensations) 7 (facing with excitement) 8 (reviewing skills and moving towards goals and maintaining achievements). The main focus of the protocol is on emotion and its three basic components, namely thoughts, physical sensations, and behavior. In the component of thoughts, the focus is on training mental errors and cognitive restructuring. In the component of bodily sensations, the techniques of awareness of bodily sensations are implemented. In the behavior component, training on the concepts of initiation and conflicting behavior is given. Finally, coping techniques with situational emotions and behavioral tests will be performed. Modals will be implemented during 12 sessions of 45 minutes for approximately 6 weeks. These modules will be distributed in the sessions according to the client's understanding and acceptance of the concepts and problems related to the preclinical symptoms of anxiety disorder, which is unique for each client. The second intervention group, the online Transdiagnostic treatment group: the intervention will be implemented online and based on the Transdiagnostic therapy (Unified protocol) for adults.This protocol has 8 modules that will be implemented in 12 sessions. The protocol modules are 1 (goal selection and maintaining motivation) 2 (understanding emotions) 3 (mindfulness of emotion) 4 (cognitive flexibility) 5 (emotional behavior) 6 (understanding and dealing with bodily sensations) 7 (facing with excitement) 8 (reviewing skills and moving towards goals and maintaining achievements). The main focus of the protocol is on emotion and its three basic components, namely thoughts, physical sensations, and behavior. In the component of thoughts, the focus is on training mental errors and cognitive restructuring. In the component of bodily sensations, the techniques of awareness of bodily sensations are implemented. In the behavior component, training on the concepts of initiation and conflicting behavior is given. Finally, coping techniques with situational emotions and behavioral tests will be performed. Modals will be implemented during 12 sessions of 45 minutes for approximately 6 weeks. These modules will be distributed in the sessions according to the client's understanding and acceptance of the concepts and problems related to the preclinical symptoms of anxiety disorder, which is unique for each client. Score in Beck's Anxiety Questionnaire. Timepoint: The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the interventionبرای. Method of measurement: Beck's anxiety questionnaire will be used for the variable of anxiety, and the subject's score in the range of 8-25 indicates the presence of subclinical symptoms of anxiety. Repetitive negative thoughts: their main characteristic is being repetitive, disturbing and unwanted. Timepoint: The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the intervention. Method of measurement: For the Repetitive negative thoughts variable, the Repetitive negative thoughts questionnaire will be used, which includes 10 questions. Anxiety sensitivity. Timepoint: The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the intervention. Method of measurement: The anxiety sensitivity questionnaire is a 16-item self-report questionnaire. The said questionnaire has 16 items and 3 subscales: physical concerns, fear of losing cognitive control, and fear of anxiety being observed by others. Positive and Negative Affect. Timepoint: The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the intervention. Method of measurement: The positive and negative affect scale is a 20-word instrument designed to measure two mood dimensions, namely positive affect and negative affect. Therapeutic alliance. Timepoint: The client and therapist versions of the therapeutic alliance Questionnaire are completed in the 6th session and the 12th session. Method of measurement: The Work Alliance Questionnaire is a questionnaire that includes two forms, client and therapist versions. Each version contains 12 questions and is scored on a Likert scale from 1 to 5. One of the most common tools for evaluating the quality of therapeutic alliance is the working alliance questionnaire. Zanjan University of Medical Sciences Approved 2023-01-11 Research Ethics Committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences , Mahdavi Blv, shahrak karmandan zanjan Zanjan Iran (Islamic Republic of)