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Internet-delivered Transdiagnostic Intervention for Anxiety and Depression

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02739607
Acronym
iTAD
Enrollment
100
Registered
2016-04-15
Start date
2016-04-30
Completion date
2017-03-31
Last updated
2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

emotional disorders, internet-delivered intervention, anxiety, depression, transdiagnostic

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.

Interventions

BEHAVIORALTransdiagnostic 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.

Sponsors

West University of Timisoara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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.
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.
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.
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.
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.
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.

Secondary

MeasureTime frameDescription
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.
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.
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.
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.

Countries

Romania

Contacts

Primary ContactBogdan Tudor Tulbure, PhD
btulbure@gmail.com0040745753061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026