Clinical trial NCT02739607: Internet-delivered Transdiagnostic Intervention for Anxiety and Depression
Official title: Internet-delivered Transdiagnostic Intervention for Anxiety and Depression in Romania- A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Dysthymic Disorder
Panic Disorder
Social Phobia
Specific Phobia
Obsessive-Compulsive Disorder
Generalized Anxiety Disorder
Keywords: emotional disorders
internet-delivered intervention
anxiety
depression
transdiagnostic
Lead sponsor: West University of Timisoara
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Absolute values (average score) of PSWQ at 11 weeks (post-intervention)
measure: Social Phobia Inventory (SPIN)
timeFrame: Absolute values (average score) of SPIN at 11 weeks (post-intervention)
measure: Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Absolute values (average score) of YBOCS at 11 weeks (post-intervention)
measure: Panic Disorder Severity Scale - Self Report (PDSS-SR)
timeFrame: Absolute values (average score) of PDSS-SR at 11 weeks (post-intervention)
measure: Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)
timeFrame: Absolute values (average score) of PCL-5 at 11 weeks (post-intervention)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Absolute values (average score) of BDI-II at 11 weeks (post-intervention)
Secondary outcomes:
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Absolute values (average score) of ERQ at 11 weeks (post-intervention)
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Absolute values (average score) of ASI at 11 weeks (post-intervention)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention)
measure: Almost Perfect Scale-Revised (APS-R)
timeFrame: Absolute values (average score) of APS-R at 11 weeks (post-intervention)
Other outcomes:
Locations:
city: Timișoara
country: Romania
facility: West University of Timisoara
state: Timiș
Study officials:
affiliation: West University of Timisoara
name: Bogdan T Tulbure, PhD
role: STUDY_DIRECTOR
References:
citation: Tulbure BT, Rusu A, Sava FA, Salagean N, Farchione TJ. A Web-Based Transdiagnostic Intervention for Affective and Mood Disorders: Randomized Controlled Trial. JMIR Ment Health. 2018 May 24;5(2):e36. doi: 10.2196/mental.8901.