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Rumination Focus Cognitive Behavior Therapy (iRFCBT)

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ClinicalTrials.gov Identifier: NCT03507114
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
University of Exeter
Information provided by (Responsible Party):
West University of Timisoara

Brief Summary:
  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.

Condition or disease Intervention/treatment Phase
Depression Dysthymic Disorder Panic Disorder Social Phobia Generalized Anxiety Disorder Behavioral: Rumination-Focused CBT (RFCBT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Folow-up interviews will be carried out by a different team of assessors (blinded to the treatment condition)
Primary Purpose: Treatment
Official Title: An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : February 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507114


Contacts
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Contact: Bogdan Tudor Tulbure, PhD 0040745753061 btulbure@gmail.com
Contact: Edward Watkins, PhD E.R.Watkins@exeter.ac.uk

Locations
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Romania
West University of Timisoara Recruiting
Timișoara, Timiș, Romania, 300223
Contact: Bogdan Tudor Tulbure, PhD    0040745753061    btulbure@gmail.com   
Sponsors and Collaborators
West University of Timisoara
University of Exeter
Investigators
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Study Director: Bogdan Tudor Tulbure, PhD West University of Timisoara

Additional Information:
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Responsible Party: West University of Timisoara
ClinicalTrials.gov Identifier: NCT03507114     History of Changes
Other Study ID Numbers: WUTimisoara-iRFCBT
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be process only at the group level. No individual data will be shared to third parties.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by West University of Timisoara:
Rumination
Cognitive behavioural therapy (CBT)
Depression
Anxiety
Additional relevant MeSH terms:
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Dysthymic Disorder
Disease
Depression
Anxiety Disorders
Panic Disorder
Phobia, Social
Pathologic Processes
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Phobic Disorders