Rumination-focused CBT Training for the Prevention of Depression and Anxiety
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by VU University of Amsterdam.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
VU University of Amsterdam
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01223677
First received: October 12, 2010
Last updated: October 18, 2010
Last verified: October 2010
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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 |
|---|---|---|
|
(Symptoms of) Depression (Symptoms of) Anxiety Disorders |
Behavioral: Rumination Focused Cognitive-Behavior Therapy |
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
| Estimated Enrollment: | 330 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: rumination focused CBT(group)
The 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 Cognitive-Behavior Therapy
see arms
Other Name: RFCBT
|
|
Active Comparator: rumination -focused CBT (online)
The 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 Cognitive-Behavior Therapy
see arms
Other Name: RFCBT
|
| Active Comparator: no training control group |
Behavioral: Rumination Focused Cognitive-Behavior Therapy
see arms
Other Name: RFCBT
|
Detailed Description:
see above
Eligibility| Ages Eligible for Study: | 15 Years to 21 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223677
Contacts
| Contact: Maurice Topper, M.Sc. | 0031202526651 | m.topper@uva.nl |
| Contact: Thomas Ehring, PhD | 0031202526858 | t.w.a.ehring@uva.nl |
Locations
| Netherlands | |
| University of Amsterdam | Recruiting |
| Amsterdam, Noord-Holland, Netherlands, 1018WB | |
| Contact: Maurice Topper, M.Sc. 0031202526651 m.topper@uva.nl | |
| Sub-Investigator: Maurice Topper, M.Sc. | |
Sponsors and Collaborators
VU University of Amsterdam
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Thomas Ehring, PhD | VU University of Amsterdam |
More Information
Publications:
| Responsible Party: | T. Ehring, University of Amsterdam |
| ClinicalTrials.gov Identifier: | NCT01223677 History of Changes |
| Other Study ID Numbers: | 50-50105-96-635 |
| Study First Received: | October 12, 2010 |
| Last Updated: | October 18, 2010 |
| 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 June 17, 2013