Internet-delivered Transdiagnostic Intervention for Anxiety and Depression

Not Applicable

• Conditions: Specific Phobia; Dysthymic Disorder; Depression; Social Phobia; Obsessive-Compulsive Disorder; Panic Disorder; Generalized Anxiety Disorder
• Interventions: Behavioral: Transdiagnostic program

• Registration Number: NCT02739607
• Lead Sponsor: West University of Timisoara

Brief Summary

Objectives

1. To test the effectiveness and acceptability of an augmented internet-supported transdiagnostic intervention in Romania.

2. To assess the cost-effectiveness of the Internet version of the transdiagnostic program as compared to a standard treatment/usual care.

Detailed Description

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06
• Primary Completion: 2016-09
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdiagnostic program	Transdiagnostic program	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.

Primary Outcome Measures

Name	Time	Method
Penn State Worry Questionnaire (PSWQ)	Absolute values (average score) of PSWQ at 11 weeks (post-intervention)	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.
Social Phobia Inventory (SPIN)	Absolute values (average score) of SPIN at 11 weeks (post-intervention)	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.
Panic Disorder Severity Scale - Self Report (PDSS-SR)	Absolute values (average score) of PDSS-SR at 11 weeks (post-intervention)	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.
Beck Depression Inventory-II (BDI-II)	Absolute values (average score) of BDI-II at 11 weeks (post-intervention)	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.
Yale-Brown Obsessive Compulsive Scale (YBOCS)	Absolute values (average score) of YBOCS at 11 weeks (post-intervention)	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.
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)	Absolute values (average score) of PCL-5 at 11 weeks (post-intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Almost Perfect Scale-Revised (APS-R)	Absolute values (average score) of APS-R at 11 weeks (post-intervention)	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.
Beck Anxiety Inventory (BAI)	Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention)	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.
Anxiety Sensitivity Index (ASI)	Absolute values (average score) of ASI at 11 weeks (post-intervention)	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.
Emotion Regulation Questionnaire (ERQ)	Absolute values (average score) of ERQ at 11 weeks (post-intervention)	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.

Trial Locations

Locations (1)

West University of Timisoara; 🇷🇴 Timișoara, Timiș, Romania