Rumination Focus Cognitive Behavior Therapy

NCT ID: NCT03507114

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-27

Study Completion Date

2019-02-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Dysthymic Disorder Panic Disorder Social Phobia Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Folow-up interviews will be carried out by a different team of assessors (blinded to the treatment condition)

Study Groups

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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.

Group Type EXPERIMENTAL

Rumination-Focused CBT (RFCBT)

Intervention Type 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.

Wait List Control Group

This arm represents the wait-list comparison group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Exeter

OTHER

Sponsor Role collaborator

West University of Timisoara

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bogdan Tudor Tulbure, PhD

Role: STUDY_DIRECTOR

West University of Timisoara

Locations

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West University of Timisoara

Timișoara, Timiș County, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Bogdan Tudor Tulbure, PhD

Role: CONTACT

0040745753061

Edward Watkins, PhD

Role: CONTACT

Facility Contacts

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Bogdan Tudor Tulbure, PhD

Role: primary

0040745753061

Related Links

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https://www.e-cbt.ro/program/brio

Project official website

Other Identifiers

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WUTimisoara-iRFCBT

Identifier Type: -

Identifier Source: org_study_id

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