Rumination Focus Cognitive Behavior Therapy (iRFCBT)
Primary Purpose
Depression, Dysthymic Disorder, Panic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Rumination-Focused CBT (RFCBT)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Rumination, Cognitive behavioural therapy (CBT), Depression, Anxiety
Eligibility Criteria
Inclusion Criteria:
- be fluent in Romanian,
- be at least 18 years of age,
- 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)
- 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:
- suicidal plans,
- changes in the dosage if psychotropic medication during the last month (if present),
- have bipolar disorder or psychosis (according to medication status)
- have an alcohol/substance abuse and/or dependence disorder
- currently take part in other psychological treatment,
- obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.);
- have a primary diagnostic of Post-Traumatic Stress Disorder and/or Obsessive Compulsive Disorder
Sites / Locations
- West University of TimisoaraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rumination-Focused CBT (RFCBT)
Wait List Control Group
Arm Description
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.
This arm represents the wait-list comparison group.
Outcomes
Primary Outcome Measures
Rumination Response Scale -10 items (RRS10)
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.
Perseverative Thinking Questionnaire (PTQ)
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.
Patient Health Questionnaire 9 (PHQ9)
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.
Generalized Anxiety Disorder 7 (GAD7)
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.
Social Phobia Inventory (SPIN)
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.
Anxiety Sensitivity Index 16 (ASI16)
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.
Secondary Outcome Measures
Work and Social Adjustment Scale (WSAS)
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).
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 ranges from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Penn State Worry Questionnaire (PSWQ)
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.
Full Information
NCT ID
NCT03507114
First Posted
April 19, 2018
Last Updated
April 25, 2018
Sponsor
West University of Timisoara
Collaborators
University of Exeter
1. Study Identification
Unique Protocol Identification Number
NCT03507114
Brief Title
Rumination Focus Cognitive Behavior Therapy
Acronym
iRFCBT
Official Title
An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
February 27, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West University of Timisoara
Collaborators
University of Exeter
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
To investigate the hypothesized mechanism of change: Repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dysthymic Disorder, Panic Disorder, Social Phobia, Generalized Anxiety Disorder
Keywords
Rumination, Cognitive behavioural therapy (CBT), Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Folow-up interviews will be carried out by a different team of assessors (blinded to the treatment condition)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rumination-Focused CBT (RFCBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
This arm represents the wait-list comparison group.
Intervention Type
Behavioral
Intervention Name(s)
Rumination-Focused CBT (RFCBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rumination Response Scale -10 items (RRS10)
Description
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.
Time Frame
Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
Title
Perseverative Thinking Questionnaire (PTQ)
Description
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.
Time Frame
Absolute values (average score) of PTQ at 8 weeks (post-intervention)
Title
Patient Health Questionnaire 9 (PHQ9)
Description
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.
Time Frame
Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)
Title
Generalized Anxiety Disorder 7 (GAD7)
Description
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.
Time Frame
Absolute values (average score) of GAD7 at 8 weeks (post-intervention)
Title
Social Phobia Inventory (SPIN)
Description
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.
Time Frame
Absolute values (average score) of SPIN at 8 weeks (post-intervention)
Title
Anxiety Sensitivity Index 16 (ASI16)
Description
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.
Time Frame
Absolute values (average score) of ASI at 8 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Work and Social Adjustment Scale (WSAS)
Description
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).
Time Frame
Absolute values (average score) of WSAS at 8 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 ranges from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Time Frame
Absolute values (average score) of BDI-II at 8 weeks (post-intervention)
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
Absolute values (average score) of PSWQ at 8 weeks (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be fluent in Romanian,
be at least 18 years of age,
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)
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:
suicidal plans,
changes in the dosage if psychotropic medication during the last month (if present),
have bipolar disorder or psychosis (according to medication status)
have an alcohol/substance abuse and/or dependence disorder
currently take part in other psychological treatment,
obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.);
have a primary diagnostic of Post-Traumatic Stress Disorder and/or Obsessive Compulsive Disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bogdan Tudor Tulbure, PhD
Phone
0040745753061
Email
btulbure@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Watkins, PhD
Email
E.R.Watkins@exeter.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan Tudor Tulbure, PhD
Organizational Affiliation
West University of Timisoara
Official's Role
Study Director
Facility Information:
Facility Name
West University of Timisoara
City
Timișoara
State/Province
Timiș
ZIP/Postal Code
300223
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Tudor Tulbure, PhD
Phone
0040745753061
Email
btulbure@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be process only at the group level. No individual data will be shared to third parties.
Links:
URL
https://www.e-cbt.ro/program/brio
Description
Project official website
Learn more about this trial
Rumination Focus Cognitive Behavior Therapy
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