Mild - Major Depression Clinical Trial
— PsiTODOfficial title:
Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)
Verified date | February 2016 |
Source | West University of Timisoara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.
Status | Terminated |
Enrollment | 79 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - be fluent in Romanian - be over 18 years - have a diagnosis of current major depression disorder - have access to an Internet connected computer Exclusion Criteria: - suicidal ideation - ongoing psychological treatment for depression - 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) |
Country | Name | City | State |
---|---|---|---|
Romania | West University of Timisoara | Timisoara | Timis |
Lead Sponsor | Collaborator |
---|---|
West University of Timisoara | Linkoeping University |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. This represents the post-intervention assessment. |
Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention) | |
Primary | 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. This represents the measure of depression at 6 month after the intervention. |
Absolute values (average score) of BDI-II at 37 weeks (follow-up) | |
Secondary | Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory (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. This represent the post-intervention assessment. |
Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention) | |
Secondary | Quality of Life Inventory (QOLI) | The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality. This represents the post-intervention assessment. |
Absolute values (average score) of QOLI at 11 weeks (post-intervention) | |
Secondary | Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression. This represents a secondary outcome measure for depression taken immediately after the intervention. |
Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment) |