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IRCT20210609051527N1 IRCT 2021-08-01 Semnan University of Medical Sciences Evaluating TCBT on mental health problems TCBT Adapting and evaluating a transdiagnostic cognitive behavioral therapy (TCBT) on common mental health problems in Iranian adults 2018-12-06 anticipated 500 Complete https://irct.ir/trial/56826 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The assessment Healthcare providers in Urban Health centers assigned an ID number to each participant in the treatment or control groups. A third independent researcher made the random ID number list using computer-generated random numbers. This list included a sequence of C (Control) and T (Treatment) using balanced block randomization with four blocks. The details of the block series were unknown to all the researchers and healthcare providers. The random allocation to the intervention or control groups was also blinded (unknown to assessment healthcare providers prior to participating), Blinding description: As the information about randomization was inserted on the allocation form, which was kept only by the independent researcher, all the healthcare providers and their supervisors remained blinded to the randomized assignment and selection bias was thus reduced. Also all participants remained blinded to their assignment. N/A Condition 1: Depression Symptoms. Condition 2: Anxiety Symptoms. Condition 3: Obsessive Compulsive Disorder Symptoms. Intervention 1: Intervention group: All the individuals rated positive in the Urban Health Centers initial mental health screening using K6 were referred to enter the study. After the introduction process and providing information about the study and its objectives, the screening interviews were conducted using the study instrument. All the participants who obtained a score at least above the cut-off point for the examined mental health problems were taken as the trial group. The participants entered the randomization, and their screening results were recorded as the baseline measurements. All the intervention participants received Transdiagnostic Cognitive Behavioral Therapy (TCBT) inspired by the Common Elements Treatment Approach (CETA). This approach allows the provider to select and compose common treatment techniques to construct a different structural treatment according to the patients’ symptom presentation or existing problems. TCBT was developed to cover the three common mental health problems in Semnan Province, namely depression, OCD, and anxiety. All participants in intervention group received eight weekly sessions lasting 60 minutes. This approach implemented by trained community healthcare providers with no mental health training background. All the community healthcare providers were taught how to manage the therapy sessions, communicate properly and apply the techniques they had learned ( using simplest and most applicable and culturally possible therapies for each mental health problem under study). The post test interviews were conducted after the completion of 8 treatment sessions. Intervention 2: Control group: All the controls were referred to receive Mental health service as usual within the national PHC network. This service which is provided by UHC’s mental health provider (mostly psychologist) includes three to four training and counseling sessions (approximately one session per month). These sessions consist of some simple and popular counseling techniques and general mental health advice within the scope of the nationally-approved instructions based on Cognitive and Behavioral Psychotherapy (CBT). The mental health provider is also responsible for the follow-up process. In this study, all the participants in control group followed up on the process of treatment service as usual through monthly phone calls. The post test interviews were conducted after four months.It should be noted that all follow-ups and completion of study instrument (initial assessment and post test interviews) were performed in both intervention and control group by the UHC healthcare providers who had received the necessary training for this study. Yes - There is a plan to make this available What will be shared: Personal data When: from date of publication to one year To whom: Journal editors and researchers according to their requests Conditions: Only analyses based on study objectives Where to obtain: Data sharing will be done based on publication and request from corresponding author How to obtain: sending email to corresponding author Comments:
public Masoumeh Dejman
Koudakyar Blvd., Daneshjou Blvd., Velenjak
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 dejman.masoumeh@gmail.com University of social welfare and rehabilitation sciences scientific Masoumeh Dejman
Koudakyar Blvd., Daneshjou Blvd., Velenjak
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 dejman.masoumeh@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) َAge at least 18 years old Referring to Urban Health Center Tested positive in the initial mental health screening using the Kessler Psychological Distress Scale (K6) 18 years no limit Both The presence of active suicide ideation, active psychosis, or major developmental delay Anyone currently receiving services for mental health or taking medication for mental health problems F32.8 F41.9 F42 Other depressive episodes Anxiety disorder, unspecified Obsessive-compulsive disorder Behavior Behavior Intervention group: All the individuals rated positive in the Urban Health Centers initial mental health screening using K6 were referred to enter the study. After the introduction process and providing information about the study and its objectives, the screening interviews were conducted using the study instrument. All the participants who obtained a score at least above the cut-off point for the examined mental health problems were taken as the trial group. The participants entered the randomization, and their screening results were recorded as the baseline measurements. All the intervention participants received Transdiagnostic Cognitive Behavioral Therapy (TCBT) inspired by the Common Elements Treatment Approach (CETA). This approach allows the provider to select and compose common treatment techniques to construct a different structural treatment according to the patients’ symptom presentation or existing problems. TCBT was developed to cover the three common mental health problems in Semnan Province, namely depression, OCD, and anxiety. All participants in intervention group received eight weekly sessions lasting 60 minutes. This approach implemented by trained community healthcare providers with no mental health training background. All the community healthcare providers were taught how to manage the therapy sessions, communicate properly and apply the techniques they had learned ( using simplest and most applicable and culturally possible therapies for each mental health problem under study). The post test interviews were conducted after the completion of 8 treatment sessions. Control group: All the controls were referred to receive Mental health service as usual within the national PHC network. This service which is provided by UHC’s mental health provider (mostly psychologist) includes three to four training and counseling sessions (approximately one session per month). These sessions consist of some simple and popular counseling techniques and general mental health advice within the scope of the nationally-approved instructions based on Cognitive and Behavioral Psychotherapy (CBT). The mental health provider is also responsible for the follow-up process. In this study, all the participants in control group followed up on the process of treatment service as usual through monthly phone calls. The post test interviews were conducted after four months.It should be noted that all follow-ups and completion of study instrument (initial assessment and post test interviews) were performed in both intervention and control group by the UHC healthcare providers who had received the necessary training for this study. The Depression score based on Persian Version of Beck Depression Inventory. Timepoint: Before the beginning of the intervention and 8 weeks after that. Method of measurement: The Persian version of Beck Depression Inventory. Anxiety score based on Persian Version of Beck Anxiety Inventory. Timepoint: Before the beginning of the intervention and 8 weeks after that. Method of measurement: The Persian version Beck Anxiety Inventory. Obsessive Compulsive Disorder score based on Yale-Brown Obsessive Compulsive Scale. Timepoint: Before the beginning of the intervention and 8 weeks after. Method of measurement: The Persian Version of Yale-Brown Obsessive Compulsive Scale. University of social welfare and rehabilitation sciences National Institute For medical Research Development University of social welfare and rehabilitation sciences Approved 2016-09-17 Ethics Committee of the National Institute for Medical Research Development (NIMAD) No. 21, Besaat Ave, West Dr Fatemi Ave, Amirabad Tehran Tehran Iran (Islamic Republic of) Approved 2016-05-23 Ethics Committee of University of Social Welfare and Rehabilitation Sciences Kodakyar Blvd., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)