NCT00247234

Brief Summary

This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

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

September 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

6.8 years

First QC Date

October 31, 2005

Last Update Submit

September 20, 2017

Conditions

Personality Disorder, BorderlineAvoidant Personality Disorder

Outcome Measures

Primary Outcomes (4)

  • quality of life

    Self-report measures

    5 years

  • depression

    Self-report measures

    5 years

  • anxiety

    Self-report measures

    5 years

  • suicidal ideation

    Self-report measures

    5 years

Secondary Outcomes (1)

  • Use of psychotropic medication

    5 years

Study Arms (2)

schema therapy

EXPERIMENTAL
Behavioral: Schema Therapy

standard care

ACTIVE COMPARATOR

standard psychiatric out-patient care

Behavioral: standard care

Interventions

Schema TherapyBEHAVIORAL

group based schema therapy

schema therapy
standard careBEHAVIORAL

standard psychiatric out-patient care

standard care

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Avoidant or Borderline personality disorders

You may not qualify if:

  • Do not speak Scandinavian languages
  • Antisocial personality disorder
  • Narcissistic personality disorder
  • Affective bipolar disorder I
  • Schizophrenia
  • Mental impairment/organic brain disorder
  • Substance dependence
  • Planned pregnancy
  • Serious somatic illness
  • Anorexia Nervosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, 7030, Norway

Location

MeSH Terms

Conditions

Borderline Personality DisorderPersonality Disorders

Interventions

Schema TherapyStandard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Are Holen, M.D., Ph.D.

    Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

September 1, 2004

Primary Completion

June 1, 2011

Study Completion

January 1, 2015

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

NO(1)