Internet-delivered Psychotherapy for Depression

NCT02091856 | Terminated Results

• 1 other identifier: WUTimisoara-PsiTOD
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild - Major Depression

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• 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)

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

  Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)

Study Arms (3)

Conventional-CBT (C-CBT)

EXPERIMENTAL

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)

Religious CBT (R-CBT)

EXPERIMENTAL

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)

Wait List Control Group (WLCG)

NO INTERVENTION

This arm represents the wait-list comparison group.

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Conventional-CBT (C-CBT); Religious CBT (R-CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be fluent in Romanian
• be over 18 years
• have a diagnosis of current major depression disorder
• have access to an Internet connected computer

You may not qualify if:

• 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)

Sponsors & Collaborators

• West University of Timisoara: lead
• Linkoeping University: collaborator

Study Sites (1)

West University of Timisoara

Timișoara, Timiș County, 300223, Romania

Location

Related Links

• Public pages describing the PsiTOD project (in Romanian)

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

1\) A high drop out rate at post-test \& follow-up. 2) The outcome assessments were not fully blind. 3) Participants in C-CBT \& R-CBT were self-selected based on their religiousness.

Results Point of Contact

• Title: Dr. Bogdan Tudor Tulbure
• Organization: West University of Timisoara

btulbure@gmail.com

+040745753061

Study Officials

• Bogdan Tudor Tulbure, PhD

  West University of Timisoara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 28, 2018
• Results First Posted: March 28, 2016

Record last verified: 2016-02

Locations

RO (1)