Effectiveness of Group Based Schema Therapy in the Treatm... | NCT00247234

Studies
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders

NCT00247234

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Sep 25, 2017Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Personality Disorder, Borderline
Avoidant Personality Disorder

Interventions

Schema Therapy
standard care

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004Actual

Primary Completion Date

Jun 2011Actual

Completion Date

Jan 2015Actual

First Submitted Date

Oct 31, 2005

First Submission Date that Met QC Criteria

Oct 31, 2005

First Posted Date

Nov 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2017

Last Update Posted Date

Sep 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
schema therapy	Experimental		Behavioral: Schema Therapy
standard care	Active Comparator	standard psychiatric out-patient care	Behavioral: standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Schema Therapy	Behavioral	group based schema therapy	schema therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Use of psychotropic medication		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Avoidant or Borderline personality disorders

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Are Holen, M.D., Ph.D.	Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Olavs Hospital		Trondheim		7030	Norway

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder
D010554	Personality Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000081843	Schema Therapy
D059039	Standard of Care

Ancestor Terms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided