Internet-delivered Psychotherapy for Depression

Not Applicable

Terminated

• Conditions: Mild - Major Depression
• Interventions: Behavioral: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT02091856
• Lead Sponsor: West University of Timisoara

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2015-11-20
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-25
• Results First Posted: 2016-03-28
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional-CBT (C-CBT)	Cognitive Behavioral Therapy (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.
Religious CBT (R-CBT)	Cognitive Behavioral Therapy (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.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory II (BDI-II)	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)	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 Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)	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.
Beck Anxiety Inventory (BAI)	Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)	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.
Quality of Life Inventory (QOLI)	Absolute values (average score) of QOLI at 11 weeks (post-intervention)	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.

Trial Locations

Locations (1)

West University of Timisoara; 🇷🇴 Timisoara, Timis, Romania