Rumination Focus Cognitive Behavior Therapy (iRFCBT)

April 25, 2018 updated by: West University of Timisoara

An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania

  1. To investigate the efficacy and acceptability of a guided internet-delivered transdiagnostic intervention targeting repetitive negative thinking for individuals with elevated levels of depression and generalized anxiety disorder (mild to moderate clinical symptoms) vs a wait-list control group (WLCG).
  2. To investigate the hypothesized mechanism of change: Repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The effectiveness of a Rumination Focused Cognitive-Behavioral Treatment (RF-CBT) will be compared with a wait list control group using a randomized control trial (RCT) design in a culture where this has not been tested before. The treatment approach was design to specifically target repetitive negative thinking (e.g., rumination and worries). Specifically, the treatment involves first a functional analysis design to help participants identify when rumination starts, distinguish between helpful versus unhelpful repetitive thinking, and learn more functional responses, and experiential and imagery exercises design to help them shift their thought processing towards concreteness, absorption and compassion. The main goal of the study is to test the effectiveness of this transdiagnostic approach in reducing symptom of depression and anxiety.

Study Type

Interventional

Enrollment (Anticipated)

90

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 Contact

Study Locations

  • Romania
    • Timiș
      • Timișoara, Timiș, Romania, 300223
        • Recruiting
        • 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:

  1. be fluent in Romanian,
  2. be at least 18 years of age,
  3. display elevated levels of worry and/or rumination (e.g., at least one self-report score above the following cut-offs: Penn State Worry Questionnaire Total score > 50 and/or Rumination Response Scale - Brooding sub-scale ≥ 10)
  4. have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, and/or panic disorder, or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I)

Exclusion Criteria:

  1. suicidal plans,
  2. changes in the dosage if psychotropic medication during the last month (if present),
  3. have bipolar disorder or psychosis (according to medication status)
  4. have an alcohol/substance abuse and/or dependence disorder
  5. currently take part in other psychological treatment,
  6. obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.);
  7. have a primary diagnostic of Post-Traumatic Stress Disorder and/or Obsessive Compulsive Disorder

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rumination-Focused CBT (RFCBT)
RFCBT seeks to change the process of thinking as opposed to the content of thoughts as in standard CBT. The underlying idea is that shifting individuals repetitive negative thinking into the concrete mode will reduce unconstructive ruminations and worries.
Behavioral: Rumination-Focused CBT (RFCBT)
RFCBT consists of six online modules that include psycho-education, mood diaries, on-line experiential exercises using audio-recordings & vignettes of participants experiences of the therapy.
No Intervention: Wait List Control Group
This arm represents the wait-list comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rumination Response Scale -10 items (RRS10)
Time Frame: Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
The Rumination Response Scale -10 items (RRS10) was designed to measure participant's level of rumination. The scale has two subscale: Reflection (5 items) and Brooding (5 items). The score for each subscale ranges from 5 to 20, while the total score ranges from 10 to 40. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
Perseverative Thinking Questionnaire (PTQ)
Time Frame: Absolute values (average score) of PTQ at 8 weeks (post-intervention)
Perseverative Thinking Questionnaire (PTQ) was designed to measure participant's level of rumination. The scale is unidimensional and the total score ranges from 0 to 60. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Absolute values (average score) of PTQ at 8 weeks (post-intervention)
Patient Health Questionnaire 9 (PHQ9)
Time Frame: Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)
The Patient Health Questionnaire 9 (PHQ9) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)
Generalized Anxiety Disorder 7 (GAD7)
Time Frame: Absolute values (average score) of GAD7 at 8 weeks (post-intervention)
Generalized Anxiety Disorder 7 (GAD7) was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 0 to 21. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Absolute values (average score) of GAD7 at 8 weeks (post-intervention)
Social Phobia Inventory (SPIN)
Time Frame: Absolute values (average score) of SPIN at 8 weeks (post-intervention)
The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score ranges from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.
Absolute values (average score) of SPIN at 8 weeks (post-intervention)
Anxiety Sensitivity Index 16 (ASI16)
Time Frame: Absolute values (average score) of ASI at 8 weeks (post-intervention)
ASI16 was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score ranges from 0 to 64. Low scores are associated with low levels of anxiety sensitivity, while high scores are associated with high levels of anxiety sensitivity.
Absolute values (average score) of ASI at 8 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work and Social Adjustment Scale (WSAS)
Time Frame: Absolute values (average score) of WSAS at 8 weeks (post-intervention)
Work and Social Adjustment Scale (WSAS) was designed to measure symptom interference. The scale is unidimensional and the total score ranges from 0 to 40. Low scores are associated with higher levels of functioning (less interference of clinical symptoms) while high scores are associated with lower levels of functioning (or high interference of clinical symptoms).
Absolute values (average score) of WSAS at 8 weeks (post-intervention)
Beck Depression Inventory-II (BDI-II)
Time Frame: Absolute values (average score) of BDI-II at 8 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 ranges from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Absolute values (average score) of BDI-II at 8 weeks (post-intervention)
Penn State Worry Questionnaire (PSWQ)
Time Frame: Absolute values (average score) of PSWQ at 8 weeks (post-intervention)
The PSWQ was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 16 to 80. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Absolute values (average score) of PSWQ at 8 weeks (post-intervention)

Collaborators and Investigators

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

Sponsor

West University of Timisoara

Collaborators

University of Exeter

Investigators

  • Study Director: 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 (Actual)

March 27, 2018

Primary Completion (Anticipated)

July 30, 2018

Study Completion (Anticipated)

February 27, 2019

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUTimisoara-iRFCBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be process only at the group level. No individual data will be shared to third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Depression

Clinical Trials on Rumination-Focused CBT (RFCBT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe