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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Thomas Ehring, Westfälische Wilhelms-Universität Münster
ClinicalTrials.gov Identifier:
NCT01223677
First received: October 12, 2010
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Depression
Anxiety Disorders
Behavioral: Rumination Focused CBT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • Beck Depression Inventory II (BDI-II) [ Time Frame: 1 year after training has ended ] [ Designated as safety issue: No ]
    self-report questionnaire of depressive symptom severity


Secondary Outcome Measures:
  • Mood and Anxiety Symptom Questionnaire (MASQ-30) [ Time Frame: 1 year after training has ended ] [ Designated as safety issue: No ]
    Symptom severity of anxiety


Enrollment: 251
Study Start Date: October 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rumination focused CBT
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.
Behavioral: Rumination Focused CBT
see arms
Other Name: RFCBT
Active Comparator: rumination focused CBT (online)
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.
Behavioral: Rumination Focused CBT
see arms
Other Name: RFCBT
No Intervention: No training control group
No training control group. Participants within this condition received no treatment, but only filled out the outcome measures at each measurement period.

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   15 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223677

Locations
Netherlands
University of Amsterdam
Amsterdam, Noord-Holland, Netherlands, 1018XA
Sponsors and Collaborators
VU University of Amsterdam
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Thomas Ehring, PhD Westfalische Wilhelms Universitat Munster
  More Information

Publications:
Responsible Party: Thomas Ehring, PhD., Westfälische Wilhelms-Universität Münster
ClinicalTrials.gov Identifier: NCT01223677     History of Changes
Other Study ID Numbers: 50-50105-96-635
Study First Received: October 12, 2010
Last Updated: June 18, 2013
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on September 11, 2014