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Clinical Trials/NCT01223677
NCT01223677CompletedPhase 1

Randomized Controlled Trial Evaluating Two Versions of a Rumination-focused CBT Training for the Presence of Depression and Anxiety in Adolescents and Young Adults

VU University of Amsterdam1 site in 1 country251 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
251
Locations
1
Primary Endpoint
Beck Depression Inventory II (BDI-II)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
15 Years to 22 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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.

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.

Intervention: Rumination Focused CBT (Behavioral)

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.

Intervention: Rumination Focused CBT (Behavioral)

Outcomes

Primary Outcomes

Beck Depression Inventory II (BDI-II)

Time Frame: 1 year after training has ended

self-report questionnaire of depressive symptom severity

Secondary Outcomes

  • Mood and Anxiety Symptom Questionnaire (MASQ-30)(1 year after training has ended)

Investigators

Sponsor
VU University of Amsterdam
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Ehring

PhD.

Universität Münster

Study Sites (1)

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