Internet-delivered Transdiagnostic Intervention for Anxiety and Depression

NCT02739607 | Unknown

• 1 other identifier: WUTimisoara-iTAD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives

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

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Emotion Regulation Questionnaire (ERQ)

  Absolute values (average score) of ERQ at 11 weeks (post-intervention)

• Anxiety Sensitivity Index (ASI)

  Absolute values (average score) of ASI at 11 weeks (post-intervention)

• Beck Anxiety Inventory (BAI)

  Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention)

• Almost Perfect Scale-Revised (APS-R)

  Absolute values (average score) of APS-R at 11 weeks (post-intervention)

Study Arms (2)

Transdiagnostic program

EXPERIMENTAL

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

Wait list control group

NO INTERVENTION

This arm represents the wait-list comparison group.

Interventions

Transdiagnostic program BEHAVIORAL

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.

Transdiagnostic program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• West University of Timisoara: lead

Study Sites (1)

West University of Timisoara

Timișoara, Timiș County, 300223, Romania

RECRUITING

Related Publications (1)

• 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.

  PMID: 29798831 DERIVED

Related Links

• Project official website

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Bogdan T Tulbure, PhD

  West University of Timisoara

  STUDY DIRECTOR

Central Study Contacts

Bogdan Tudor Tulbure, PhD

CONTACT

0040745753061; btulbure@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)