DepressioniTADNCT02739607
Internet-delivered Transdiagnostic Intervention for Anxiety and Depression
A study testing Transdiagnostic program in people with Depression and Dysthymic Disorder, run by West University of Timisoara at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Dysthymic Disorder, Panic Disorder
- What is being tested?
- Transdiagnostic program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- Apr 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
West University of Timisoara
Timișoara, Timiș County, 300223
Bogdan Tudor Tulbure, PhD, 0040745753061, btulbure@gmail.com
About this study
Official title: Internet-delivered Transdiagnostic Intervention for Anxiety and Depression in Romania- A Randomized Control Trial
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.
Read the 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.
- Conditions
- Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder
- Being tested
- Transdiagnostic program
- Keywords
- emotional disorders, internet-delivered intervention, anxiety, depression, transdiagnostic
- Medical subject headings
- Depression, Dysthymic Disorder, Panic Disorder, Phobia, Social, Phobia, Specific, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transdiagnostic program |
| Wait list control group | No intervention | This arm represents the wait-list comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Absolute values (average score) of BDI-II at 11 weeks (post-intervention)
Secondary outcomes (4)
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.
Measured: Absolute values (average score) of ERQ at 11 weeks (post-intervention)
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.
Measured: Absolute values (average score) of ASI at 11 weeks (post-intervention)
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.
Measured: Absolute values (average score) of Treatment satisfaction and acceptability at 11 weeks (post-intervention)
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.
Measured: Absolute values (average score) of APS-R at 11 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West University of Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bogdan T Tulbure, PhD, Study director, West University of Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739607
- Sponsor's protocol ID
- WUTimisoara-iTAD
- Acronym
- iTAD
- Status last verified
- May 2016
- First submitted
- 12 Apr 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be process only at the group level. No individual data will be shared to third parties.
Publications
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.
PubMed 29798831
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Transdiagnostic Intervention for Anxiety and Depression in Romania- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02739607
- Acronym / sponsor ID
- iTAD / WUTimisoara-iTAD
- Conditions
- Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder
- Keywords
- emotional disorders, internet-delivered intervention, anxiety, depression, transdiagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West University of TimisoaraUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic program | Experimental | Behavioral: Transdiagnostic programThis 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. |
| Wait list control group | No intervention | –This arm represents the wait-list comparison group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic programThis 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. | Behavioural | Transdiagnostic program |
Primary outcome
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Emotion Regulation Questionnaire (ERQ)
Time frame: 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)
Beck Anxiety Inventory (BAI)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Derived from this study: PubMed 29798831Tulbure 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.
- Project official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be process only at the group level. No individual data will be shared to third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan T Tulbure, PhD study director
West University of Timisoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic program in people with Depression and Dysthymic Disorder, run by West University of Timisoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bogdan Tudor Tulbure, PhD (0040745753061, btulbure@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn State Worry Questionnaire (PSWQ) (time frame: Absolute values (average score) of PSWQ at 11 weeks (post-intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02739607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.