Rumination Focus Cognitive Behavior Therapy

NCT03507114 | Unknown

• 1 other identifier: WUTimisoara-iRFCBT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To investigate the hypothesized mechanism of change: Repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.

Conditions

Depression; Dysthymic Disorder; Panic Disorder; Social Phobia; Generalized Anxiety Disorder

Keywords

Rumination; Cognitive behavioural therapy (CBT); Depression; Anxiety

Outcome Measures

Primary Outcomes (6)

• 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.

  Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)

• 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.

  Absolute values (average score) of PTQ at 8 weeks (post-intervention)

• 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.

  Absolute values (average score) of PHQ9 at 8 weeks (post-intervention)

• 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.

  Absolute values (average score) of GAD7 at 8 weeks (post-intervention)

• 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.

  Absolute values (average score) of SPIN at 8 weeks (post-intervention)

• 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.

  Absolute values (average score) of ASI at 8 weeks (post-intervention)

Secondary Outcomes (3)

• Work and Social Adjustment Scale (WSAS)

  Absolute values (average score) of WSAS at 8 weeks (post-intervention)

• Beck Depression Inventory-II (BDI-II)

  Absolute values (average score) of BDI-II at 8 weeks (post-intervention)

• Penn State Worry Questionnaire (PSWQ)

  Absolute values (average score) of PSWQ at 8 weeks (post-intervention)

Study Arms (2)

Rumination-Focused CBT (RFCBT)

EXPERIMENTAL

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)

Wait List Control Group

NO INTERVENTION

This arm represents the wait-list comparison group.

Interventions

Rumination-Focused CBT (RFCBT) BEHAVIORAL

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.

Rumination-Focused CBT (RFCBT)

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 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

West University of Timisoara

Timișoara, Timiș County, 300223, Romania

RECRUITING

Related Links

• Project official website

MeSH Terms

Conditions

Depression; Dysthymic Disorder; Panic Disorder; Phobia, Social; Generalized Anxiety Disorder; Rumination Syndrome; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Phobic Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Study Officials

• Bogdan Tudor Tulbure, PhD

  West University of Timisoara

  STUDY DIRECTOR

Central Study Contacts

Bogdan Tudor Tulbure, PhD

CONTACT

0040745753061; btulbure@gmail.com

Edward Watkins, PhD

CONTACT

E.R.Watkins@exeter.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Folow-up interviews will be carried out by a different team of assessors (blinded to the treatment condition)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: April 24, 2018
• Study Start: March 27, 2018
• Primary Completion: July 30, 2018
• Study Completion: February 27, 2019
• Last Updated: April 27, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)