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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03074669 |
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Date of registration:
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28/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Online Acceptance and Commitment Therapy for Reducing Anxiety
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Scientific title:
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Internet-delivered Acceptance and Commitment Therapy for Reducing Anxiety Symptoms |
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Date of first enrolment:
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March 15, 2017 |
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Target sample size:
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80 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03074669 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Romania
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Contacts
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Name:
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Bogdan Tudor Tulbure, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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West University of Timisoara |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- be fluent in Romanian
- be over 18 years of age
- have high levels of anxiety
- have access to an Internet-connected computer
Exclusion Criteria:
- suicidal ideation
- substance abuse
- severe psychiatric disorders
- a recent change in psychotropic medication (i.e., the dose has been changed within the
last month)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anxiety Disorder/Anxiety State
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Intervention(s)
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Behavioral: ACT program
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Primary Outcome(s)
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Changes in Anxiety Sensitivity Index (ASI)
[Time Frame: Change from Pre- to Post-Intervention (7 weeks), and Change from Post-intervention (week 7) to Follow-up (6 month post-intervention)]
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Secondary Outcome(s)
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Penn State Worry Questionnaire (PSWQ)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)
[Time Frame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Work and Social Adjustment Scale (WSAS)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Overall Depression Severity and Impairment Scale (ODSIS)
[Time Frame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]]
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Believability of Anxious Feelings and Thoughts Questionnaire (BAFT)
[Time Frame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Mindful Attention Awareness Scale (MAAS)
[Time Frame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Quality of Life Inventory (QOLI)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Social Phobia Inventory (SPIN)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Yale-Brown Obsessive Compulsive Scale (YBOCS)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Acceptance and Action Questionnaire 2 (AAQ2)
[Time Frame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Beck Depression Inventory-II (BDI-II)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Overall Anxiety Severity and Impairment Scale (OASIS)
[Time Frame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Panic Disorder Severity Scale - Self Report (PDSS-SR)
[Time Frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
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Secondary ID(s)
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WUTimisoara ACT-online
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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