Internet-delivered Psychotherapy for Depression

Mild - Major Depression Clinical Trial

— PsiTOD  

Official title:

Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02091856
• Other study ID #: WUTimisoara-PsiTOD
• Status: Terminated
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: West University of Timisoara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Mild - Major Depression

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)
Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.

Locations

Country	Name	City	State
Romania	West University of Timisoara	Timisoara	Timis

Sponsors (2)

Lead Sponsor	Collaborator
West University of Timisoara	Linkoeping University

Country where clinical trial is conducted

Romania, 

Outcome

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)

External Links

•   Public pages describing the PsiTOD project (in Romanian)