search
Back to results

Rumination-focused CBT Training for the Prevention of Depression and Anxiety

Primary Purpose

Depression, Anxiety Disorders

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Rumination Focused CBT
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

15 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A score above the 75% and 66.7% percentile on two validated self-report measures of rumination and worry, the Ruminative Response Scale of the Response Style Questionnaire (RSQ; Nolen-Hoeksema & Morrow, 1991), and the Penn State Worry Questionnaire (PSWQ; Meyer et al. 1990).

Exclusion Criteria:

  • A score indicating fulfillment of DSM-IV criteria for depression or generalized anxiety disorder according to the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) or the Generalized Anxiety Disorder Questionnaire-IV (GADQ-IV; Newman et al., 2002)

Sites / Locations

  • University of Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

rumination focused CBT

rumination focused CBT (online)

No training control group

Arm Description

RFCBT-group. This group training is based on research showing that dysfunctional forms of rumination are characterized by an abstract evaluative style of processing, whereas functional forms of of processing are more concrete and process-focused. The training uses psycho-education, functional analysis, group discussion, experiential exercises and behavioral experiments to facilitate the shift from dysfunctional ruminative thinking to a more helpful concrete thinking style.

The online training is based on research showing that dysfunctional forms of rumination are characterized by an abstract evaluative style of processing, whereas functional forms of of processing are more concrete and process-focused. The training uses psycho-education, functional analysis, experiential exercises and behavioral experiments to facilitate the shift from dysfunctional ruminative thinking to a more helpful concrete thinking style.

No training control group. Participants within this condition received no treatment, but only filled out the outcome measures at each measurement period.

Outcomes

Primary Outcome Measures

Beck Depression Inventory II (BDI-II)
self-report questionnaire of depressive symptom severity

Secondary Outcome Measures

Mood and Anxiety Symptom Questionnaire (MASQ-30)
Symptom severity of anxiety

Full Information

First Posted
October 12, 2010
Last Updated
December 1, 2014
Sponsor
VU University of Amsterdam
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01223677
Brief Title
Rumination-focused CBT Training for the Prevention of Depression and Anxiety
Official Title
Randomized Controlled Trial Evaluating Two Versions of a Rumination-focused CBT Training for the Presence of Depression and Anxiety in Adolescents and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Depression and anxiety disorders are highly prevalent and associated with reduced quality of life for patients and enormous economic costs for society. Although effective treatments are available, a substantial number of patients fail to respond, and the time between disorder onset and treatment is typically long. The development of prevention programs therefore appears promising. The current project aims to prevent depression and anxiety by targeting excessive levels of worry and rumination, two important risk factors for emotional disorders. Participants will be selected on the basis of a high score on two validated questionnaires on worry and rumination. They will be randomly assigned to a rumination-focused cognitive-behavioral training delivered in a group format, a rumination-focused cognitive-behavioral training delivered via internet, or a no-training control condition. It is expected that both versions of the rumination-focused training will reduce symptoms of depression and anxiety, will reduce the incidence of major depressive episodes and generalized anxiety disorder, and will reduce symptom levels of other emotional disorders.
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rumination focused CBT
Arm Type
Active Comparator
Arm Description
RFCBT-group. This group training is based on research showing that dysfunctional forms of rumination are characterized by an abstract evaluative style of processing, whereas functional forms of of processing are more concrete and process-focused. The training uses psycho-education, functional analysis, group discussion, experiential exercises and behavioral experiments to facilitate the shift from dysfunctional ruminative thinking to a more helpful concrete thinking style.
Arm Title
rumination focused CBT (online)
Arm Type
Active Comparator
Arm Description
The online training is based on research showing that dysfunctional forms of rumination are characterized by an abstract evaluative style of processing, whereas functional forms of of processing are more concrete and process-focused. The training uses psycho-education, functional analysis, experiential exercises and behavioral experiments to facilitate the shift from dysfunctional ruminative thinking to a more helpful concrete thinking style.
Arm Title
No training control group
Arm Type
No Intervention
Arm Description
No training control group. Participants within this condition received no treatment, but only filled out the outcome measures at each measurement period.
Intervention Type
Behavioral
Intervention Name(s)
Rumination Focused CBT
Other Intervention Name(s)
RFCBT
Intervention Description
see arms
Primary Outcome Measure Information:
Title
Beck Depression Inventory II (BDI-II)
Description
self-report questionnaire of depressive symptom severity
Time Frame
1 year after training has ended
Secondary Outcome Measure Information:
Title
Mood and Anxiety Symptom Questionnaire (MASQ-30)
Description
Symptom severity of anxiety
Time Frame
1 year after training has ended

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A score above the 75% and 66.7% percentile on two validated self-report measures of rumination and worry, the Ruminative Response Scale of the Response Style Questionnaire (RSQ; Nolen-Hoeksema & Morrow, 1991), and the Penn State Worry Questionnaire (PSWQ; Meyer et al. 1990). Exclusion Criteria: A score indicating fulfillment of DSM-IV criteria for depression or generalized anxiety disorder according to the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) or the Generalized Anxiety Disorder Questionnaire-IV (GADQ-IV; Newman et al., 2002)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ehring, PhD
Organizational Affiliation
Westfalische Wilhelms Universitat Munster
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Amsterdam
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1018XA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19036353
Citation
Watkins ER, Moberly NJ. Concreteness training reduces dysphoria: a pilot proof-of-principle study. Behav Res Ther. 2009 Jan;47(1):48-53. doi: 10.1016/j.brat.2008.10.014. Epub 2008 Oct 21.
Results Reference
background

Learn more about this trial

Rumination-focused CBT Training for the Prevention of Depression and Anxiety

We'll reach out to this number within 24 hrs