Internet-delivered Transdiagnostic Intervention for Anxiety and Depression (iTAD)

May 5, 2016 updated by: West University of Timisoara

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timiș
      • Timișoara, Timiș, Romania, 300223
        • Recruiting
        • West University of Timisoara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Transdiagnostic program
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.
NO_INTERVENTION: Wait list control group
This arm represents the wait-list comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penn State Worry Questionnaire (PSWQ)
Time Frame: 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.
Absolute values (average score) of PSWQ at 11 weeks (post-intervention)
Social Phobia Inventory (SPIN)
Time Frame: 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.
Absolute values (average score) of SPIN at 11 weeks (post-intervention)
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: 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.
Absolute values (average score) of YBOCS at 11 weeks (post-intervention)
Panic Disorder Severity Scale - Self Report (PDSS-SR)
Time Frame: 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.
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)
Time Frame: 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.
Absolute values (average score) of PCL-5 at 11 weeks (post-intervention)
Beck Depression Inventory-II (BDI-II)
Time Frame: 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.
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)
Time Frame: 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.
Absolute values (average score) of ERQ at 11 weeks (post-intervention)
Anxiety Sensitivity Index (ASI)
Time Frame: 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.
Absolute values (average score) of ASI at 11 weeks (post-intervention)
Beck Anxiety Inventory (BAI)
Time Frame: 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.
Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention)
Almost Perfect Scale-Revised (APS-R)
Time Frame: 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.
Absolute values (average score) of APS-R at 11 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West University of Timisoara

Investigators

  • Study Director: Bogdan T Tulbure, PhD, West University of Timisoara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2016

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (ESTIMATE)

April 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUTimisoara-iTAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be process only at the group level. No individual data will be shared to third parties.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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