Internet-delivered Transdiagnostic Intervention for Anxiety and Depression (iTAD)
Primary Purpose
Depression, Dysthymic Disorder, Panic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Transdiagnostic program
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring emotional disorders, internet-delivered intervention, anxiety, depression, transdiagnostic
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)
Sites / Locations
- West University of TimisoaraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transdiagnostic program
Wait list control group
Arm Description
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.
This arm represents the wait-list comparison group.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02739607
First Posted
April 12, 2016
Last Updated
May 5, 2016
Sponsor
West University of Timisoara
1. Study Identification
Unique Protocol Identification Number
NCT02739607
Brief Title
Internet-delivered Transdiagnostic Intervention for Anxiety and Depression
Acronym
iTAD
Official Title
Internet-delivered Transdiagnostic Intervention for Anxiety and Depression in Romania- A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West University of Timisoara
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder
Keywords
emotional disorders, internet-delivered intervention, anxiety, depression, transdiagnostic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transdiagnostic program
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list control group
Arm Type
No Intervention
Arm Description
This arm represents the wait-list comparison group.
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
Absolute values (average score) of PSWQ at 11 weeks (post-intervention)
Title
Social Phobia Inventory (SPIN)
Description
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.
Time Frame
Absolute values (average score) of SPIN at 11 weeks (post-intervention)
Title
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Description
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.
Time Frame
Absolute values (average score) of YBOCS at 11 weeks (post-intervention)
Title
Panic Disorder Severity Scale - Self Report (PDSS-SR)
Description
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.
Time Frame
Absolute values (average score) of PDSS-SR at 11 weeks (post-intervention)
Title
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)
Description
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.
Time Frame
Absolute values (average score) of PCL-5 at 11 weeks (post-intervention)
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Absolute values (average score) of BDI-II at 11 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Emotion Regulation Questionnaire (ERQ)
Description
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.
Time Frame
Absolute values (average score) of ERQ at 11 weeks (post-intervention)
Title
Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
Absolute values (average score) of ASI at 11 weeks (post-intervention)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention)
Title
Almost Perfect Scale-Revised (APS-R)
Description
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.
Time Frame
Absolute values (average score) of APS-R at 11 weeks (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bogdan Tudor Tulbure, PhD
Phone
0040745753061
Email
btulbure@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan T Tulbure, PhD
Organizational Affiliation
West University of Timisoara
Official's Role
Study Director
Facility Information:
Facility Name
West University of Timisoara
City
Timișoara
State/Province
Timiș
ZIP/Postal Code
300223
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Tudor Tulbure, PhD
Phone
0040745753061
Email
btulbure@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be process only at the group level. No individual data will be shared to third parties.
Citations:
PubMed Identifier
29798831
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.
Results Reference
derived
Links:
URL
http://e-cbt.ro/program/psitad
Description
Project official website
Learn more about this trial
Internet-delivered Transdiagnostic Intervention for Anxiety and Depression
We'll reach out to this number within 24 hrs