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Internet-delivered Psychotherapy for Depression (PsiTOD)

Primary Purpose

Mild - Major Depression

Status
Terminated
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Sponsored by
West University of Timisoara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild - Major Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • West University of Timisoara

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Conventional-CBT (C-CBT)

Religious CBT (R-CBT)

Wait List Control Group (WLCG)

Arm Description

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.

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.

This arm represents the wait-list comparison group.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 5, 2014
Last Updated
April 19, 2018
Sponsor
West University of Timisoara
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT02091856
Brief Title
Internet-delivered Psychotherapy for Depression
Acronym
PsiTOD
Official Title
Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
We have recruited and treated 79 participants
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West University of Timisoara
Collaborators
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild - Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional-CBT (C-CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Religious CBT (R-CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Group (WLCG)
Arm Type
No Intervention
Arm Description
This arm represents the wait-list comparison group.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)
Title
Beck Depression Inventory II (BDI-II)
Description
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.
Time Frame
Absolute values (average score) of BDI-II at 37 weeks (follow-up)
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)
Title
Quality of Life Inventory (QOLI)
Description
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.
Time Frame
Absolute values (average score) of QOLI at 11 weeks (post-intervention)
Title
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Description
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.
Time Frame
Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan Tudor Tulbure, PhD
Organizational Affiliation
West University of Timisoara
Official's Role
Principal Investigator
Facility Information:
Facility Name
West University of Timisoara
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300223
Country
Romania

12. IPD Sharing Statement

Links:
URL
https://www.iterapi.se/sites/psitod
Description
Public pages describing the PsiTOD project (in Romanian)

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Internet-delivered Psychotherapy for Depression

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