Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- West University of Timisoara
- Enrollment
- 79
- Locations
- 2
- Primary Endpoint
- Beck Depression Inventory II (BDI-II)
Study Overview
Brief Summary
Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.
Detailed Description
Previous studies suggest that incorporating religious beliefs into conventional CBT appears to be helpful for religious individuals. In order to have two active comparable interventions the investigators added to the conventional CBT a similar set of exercises devised from the positive psychology paradigm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Conventional-CBT (C-CBT)
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.
Intervention: Cognitive Behavioral Therapy (CBT) (Behavioral)
Religious CBT (R-CBT)
This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.
Intervention: Cognitive Behavioral Therapy (CBT) (Behavioral)
Wait List Control Group (WLCG)
This arm represents the wait-list comparison group.
Outcomes
Primary Outcomes
Beck Depression Inventory II (BDI-II)
Time Frame: Absolute values (average score) of BDI-II at 37 weeks (follow-up)
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.
Beck Depression Inventory-II (BDI-II)
Time Frame: Absolute values (average score) of Back Depression Inventory-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. This represents the post-intervention assessment.
Secondary Outcomes
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)(Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment))
- Beck Anxiety Inventory (BAI)(Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention))
- Quality of Life Inventory (QOLI)(Absolute values (average score) of QOLI at 11 weeks (post-intervention))