NCT01223677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3.9 years

First QC Date

October 12, 2010

Last Update Submit

December 1, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory II (BDI-II)

    self-report questionnaire of depressive symptom severity

    1 year after training has ended

Secondary Outcomes (1)

  • Mood and Anxiety Symptom Questionnaire (MASQ-30)

    1 year after training has ended

Study Arms (3)

rumination focused CBT

ACTIVE COMPARATOR

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

rumination focused CBT (online)

ACTIVE COMPARATOR

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

No training control group

NO INTERVENTION

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

Interventions

see arms

Also known as: RFCBT
rumination focused CBTrumination focused CBT (online)

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Amsterdam

Amsterdam, North Holland, 1018XA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19036353BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Thomas Ehring, PhD

    Westfalische Wilhelms Universitat Munster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 19, 2010

Study Start

October 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations