NCT00494858

Brief Summary

This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

5.4 years

First QC Date

June 28, 2007

Last Update Submit

July 18, 2016

Conditions

Keywords

Bulimia nervosaCognitive Behavioral TherapyPersonality Disorders

Outcome Measures

Primary Outcomes (1)

  • Eating disorder symptoms

    Measured throughout the study

Secondary Outcomes (3)

  • Depression symptoms

    Measured throughout the study

  • Anxiety symptoms

    Measured throughout the study

  • Interpersonal relationships

    Measured throughout the study

Study Arms (2)

CBT-EF

ACTIVE COMPARATOR

Participants will receive cognitive behavioral therapy - focused

Behavioral: Cognitive behavioral therapy - focused (CBT-EF)

CBT-EB

EXPERIMENTAL

Participants will receive cognitive behavioral therapy - broad

Behavioral: Cognitive behavioral therapy - broad (EB)

Interventions

Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.

CBT-EF

Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.

CBT-EB

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of bulimia nervosa
  • Presence of borderline personality disorder features
  • History of one mood or anxiety episode within 2 years prior to study entry
  • If taking psychiatric medication, dose has been stable for at least 6 weeks at time of study entry

You may not qualify if:

  • Substance dependence
  • Diagnosis of bipolar I disorder
  • Psychosis
  • Mental retardation
  • Receiving psychosocial treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Anxiety and Related Disorders, Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia NervosaPersonality Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Heather Thompson-Brenner, PhD

    Center for Anxiety and Related Disorders, Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations