]>
IRCT20171029037068N1 IRCT 2023-09-23 Ferdowsi University of Mashhad Transdiagnostic therapy based on the research domain criteria framework for non-suicidal self-injury Effectiveness of transdiagnostic therapy based on the research domain criteria framework compared with treatment as usual and transcranial direct current stimulation for youth non-suicidal self-injury: A randomized controlled trial 2022-06-02 anticipated 68 Complete https://irct.ir/trial/70159 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple randomization method was performed with the help of SAS software. In this way, each subject is registered in the software and a code is defined for each person. Then, by means of the software, they are randomly divided into three intervention groups, Blinding description: Participants assumed that all participants would receive the intervention. N/A Nonsuicidal self-injury. Intervention 1: Intervention group 1: TTB-RDoC is a group intervention program for youth with NSSI (18–30-year-olds). It comprises 16 sessions (twice a week) of 45 min. This program consists of four modules. Module 1: Emotion Regulation, Module 2: Cognitive Training, Module 3: Behavioral Activation and Module 4: Interpersonal Skills. Each module is held in 4 sessions. Intervention 2: Intervention group 2: The tDCS will deliver using two 5×7 cm electrodes covered in saline-soaked sponges. Electrodes were placed with a bipolar-balanced montage with anode on the right DLPFC (F4) and cathode on the left DLPFC (F3) according to EEG 10-20 system. tDCS was administered in a daily session lasting 20 min for 5 working days/week for 4 consecutive weeks. Intervention 3: Control group: TAU protocol includes new techniques from 'third' wave CBT, Acceptance Commitment Therapy (ACT) and Dialectical Behavior Therapy (DBT). The manual is evidence based and focuses on a flexible and formulation driven model to direct treatment in 15 sessions of 45 minutes and 2 sessions a week for young people. Cognitive-behavioral methodological techniques were performed in 5 sessions, including correction of cognitive errors, emotional regulation, and behavioral activation. Treatment techniques of commitment and acceptance in 5 sessions and included cognitive breakdown, self as background, conscious mind, values and acceptance and commitment.Dialectical behavioral therapy techniques in 5 sessions and included mindfulness, distress tolerance, interpersonal effectiveness and emotion control. Yes - There is a plan to make this available What will be shared: All potential data can be shared after de-identifying individuals When: The data will become available 3 months after the results are published To whom: There is no specific limitation and it will be accessible to all researchers in this field Conditions: Currently, there are no special conditions and restrictions Where to obtain: We will respond to applicants via email How to obtain: The aims and objectives of the research should be clearly explained. Comments:
public Imanollah Bigdeli
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
Mashhad Iran (Islamic Republic of) 9188355827 +98 51 3880 5865 ibigdeli@um.ac.ir Ferdowsi University of Mashhad scientific Hossein Farrokhi
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
Mashhad Iran (Islamic Republic of) 9188355827 +98 51 3868 0489 hossein.farrokhi110@gmail.com Ferdowsi University of Mashhad Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Primary DSM-5 diagnosis of non-suicidal self-injury (NSSI) No usage of medication Being at the age of 18-30 years old Speaking Persian fluently Ability to participate in all assessment and treatment sessions 18 years 30 years Male Need for immediate medical treatment or the need for concurrent therapeutic interventions that would interfere with the treatment program Receiving a full course of pharmacotherapy or psychotherapy, within the past 5 years Having psychiatric disorders and substance abuse (except tobacco users) within twelve months before screening Current diagnosis of any mental disorder A history of epilepsy Significant head injury or other neurological conditions, or brain surgery A history of adverse reaction to tDCS or having a sensitive scalp Patient's opposition to collaboration at any time of research Having serious thoughts about suicide Behavior Treatment - Devices Behavior Intervention group 1: TTB-RDoC is a group intervention program for youth with NSSI (18–30-year-olds). It comprises 16 sessions (twice a week) of 45 min. This program consists of four modules. Module 1: Emotion Regulation, Module 2: Cognitive Training, Module 3: Behavioral Activation and Module 4: Interpersonal Skills. Each module is held in 4 sessions. Intervention group 2: The tDCS will deliver using two 5×7 cm electrodes covered in saline-soaked sponges. Electrodes were placed with a bipolar-balanced montage with anode on the right DLPFC (F4) and cathode on the left DLPFC (F3) according to EEG 10-20 system. tDCS was administered in a daily session lasting 20 min for 5 working days/week for 4 consecutive weeks Control group: TAU protocol includes new techniques from 'third' wave CBT, Acceptance Commitment Therapy (ACT) and Dialectical Behavior Therapy (DBT). The manual is evidence based and focuses on a flexible and formulation driven model to direct treatment in 15 sessions of 45 minutes and 2 sessions a week for young people. Cognitive-behavioral methodological techniques were performed in 5 sessions, including correction of cognitive errors, emotional regulation, and behavioral activation. Treatment techniques of commitment and acceptance in 5 sessions and included cognitive breakdown, self as background, conscious mind, values and acceptance and commitment.Dialectical behavioral therapy techniques in 5 sessions and included mindfulness, distress tolerance, interpersonal effectiveness and emotion control. Nonsuicidal self-injury. Timepoint: At baseline (pre-treatment), at 8th weeks (post-treatment), and after a 12-month post-treatment followup period. Method of measurement: Inventory of statements about self-injury (ISAS), Structured clinical interview for DSM‐5 disorders‐clinician version. Ferdowsi University of Mashhad Approved 2023-03-14 Research Ethics Committee of Ferdowsi University of Mashhad No. 10, Kalantari Blvd, Azadi Sq, Mashhad. Mashhad Razavi Khorasan Iran (Islamic Republic of)