Internet-delivered Transdiagnostic Intervention for Anxiety and Depression

Study Overview
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Brief Summary
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Objectives To test the effectiveness and acceptability of an augmented internet-supported transdiagnostic intervention in Romania. To assess the cost-effectiveness of the Internet version of the transdiagnostic program as compared to a standard treatment/usual care.

Detailed Description
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The effectiveness of a transdiagnostic intervention will be compared with a wait list control group using a randomized control trial (RCT) design in a culture where this has not been tested before. The treatment approach is mainly emotion-focus, teaching participants how to confront and experience uncomfortable emotions, and how more adaptive coping mechanisms could be used. Because internet-delivered interventions represent an effective way to disseminate evidence-based programs, investigators decided to present our intervention online.

Official Title
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Internet-delivered Transdiagnostic Intervention for Anxiety and Depression in Romania- A Randomized Control Trial

Conditions
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Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Transdiagnostic program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be fluent in Romanian be over 18 years have the principal diagnostic of generalized anxiety disorder and/or obsessive-compulsive disorder and/or panic disorder and/or social anxiety disorder and/or major depression disorder and/or dysthymia (or any combination of these diagnostics) on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I) have access to an Internet connected computer Exclusion Criteria: suicidal ideation ongoing psychological treatment for generalized anxiety disorder and/or obsessive-compulsive disorder and/or panic disorder and/or social anxiety disorder and/or major depression disorder and/or dysthymia other primary disorder that need treatment obstacle to participation (i.e., long travel plans) recent change in psychiatric medication (i.e., during the last 6 weeks)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdiagnostic program<br>This arm represents the Transdiagnostic intervention program for emotional disorders. The intervention, based on the Cognitive Behavioral Therapy (CBT) principles, is designed to encourage participants to confront and experience uncomfortable emotions, and use adaptive coping mechanisms. | Behavioral: Transdiagnostic program<br>* This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors.<br>|
| No Intervention: Wait list control group<br>This arm represents the wait-list comparison group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penn State Worry Questionnaire (PSWQ) | The PSWQ was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score rages from 16 to 80. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry. | Absolute values (average score) of PSWQ at 11 weeks (post-intervention) | 
| Social Phobia Inventory (SPIN) | The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score rages from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia. | Absolute values (average score) of SPIN at 11 weeks (post-intervention) | 
| Yale-Brown Obsessive Compulsive Scale (YBOCS) | The YBOCS was designed to measure participant's level of obsessions and compulsions (O&C). The scale total score rages from 0 to 40. Low scores are associated with low levels of O&C, while high scores are associated with high levels of O&C. | Absolute values (average score) of YBOCS at 11 weeks (post-intervention) | 
| Panic Disorder Severity Scale - Self Report (PDSS-SR) | The PDSS-SR was designed to measure participant's level of panic. The scale is unidimensional and the total score rages from 0 to 28. Low scores are associated with low levels of panic, while high scores are associated with high levels of panic. | Absolute values (average score) of PDSS-SR at 11 weeks (post-intervention) | 
| Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5) | The PCL-5 was designed to measure participant's level of post-traumatic stress. The scale is unidimensional and the total score rages from 0 to 80. Low scores are associated with low levels of post-traumatic stress, while high scores are associated with high levels of post-traumatic stress. | Absolute values (average score) of PCL-5 at 11 weeks (post-intervention) | 
| Beck Depression Inventory-II (BDI-II) | The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. | Absolute values (average score) of BDI-II at 11 weeks (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Regulation Questionnaire (ERQ) | The ERQ was designed to measure participant's level of emotion regulation. The scale is multidimensional and measures two emotion regulation strategies: reappraisal and suppression. Low scores are associated with low levels of emotion regulation, while high scores are associated with high levels of emotion regulation. | Absolute values (average score) of ERQ at 11 weeks (post-intervention) | 
| Anxiety Sensitivity Index (ASI) | The ASI was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score rages from 0 to 64. Low scores are associated with low levels of anxiety sensitivity, while high scores are associated with high levels of anxiety sensitivity. | Absolute values (average score) of ASI at 11 weeks (post-intervention) | 
| Beck Anxiety Inventory (BAI) | The BAI was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety. | Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention) | 
| Almost Perfect Scale-Revised (APS-R) | The APS-R was designed to measure participant's level of perfectionism. The scale is multidimensional and measures three dimensions of perfectionism: high standards, order and discrepancy. Low scores are associated with low levels of perfectionism, while high scores are associated with high levels of perfectionism. | Absolute values (average score) of APS-R at 11 weeks (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emotional disorders, internet-delivered intervention, anxiety, depression, transdiagnostic