Internet-delivered Psychotherapy for Depression (PsiTOD)

April 19, 2018 updated by: West University of Timisoara

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

Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300223
        • West University of Timisoara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
No Intervention: Wait List Control Group (WLCG)
This arm represents the wait-list comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)
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.
Absolute values (average score) of BDI-II at 37 weeks (follow-up)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West University of Timisoara

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Bogdan Tudor Tulbure, PhD, West University of Timisoara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUTimisoara-PsiTOD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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