NCT00601822

Brief Summary

This study will evaluate the effectiveness of adding cognitive remediation therapy to cognitive behavioral therapy for treating people with anorexia nervosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

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

Study Start

First participant enrolled

January 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

3.9 years

First QC Date

January 4, 2008

Last Update Submit

April 9, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of time to discontinue treatment (attrition rate)

    Measured at Month 6

Secondary Outcomes (1)

  • Changes in general cognitive processes and those related to anorexia nervosa

    Measured at Month 6

Study Arms (2)

1

EXPERIMENTAL

Group receiving cognitive behavioral therapy for anorexia nervosa (CBT-AN)

Behavioral: Cognitive behavioral therapy (CBT)

2

EXPERIMENTAL

Group receiving cognitive behavioral therapy for anorexia nervosa, plus cognitive remediation therapy (CBT-AN+CRT)

Behavioral: Cognitive remediation therapy (CRT)Behavioral: Cognitive behavioral therapy (CBT)

Interventions

CRT includes eight sessions over 6 months that aim to improve cognitive flexibility and strengthen thinking skills.

2

CBT includes 20 to 28 weekly psychotherapy sessions over 6 months, depending on treatment group assignment. CBT sessions aim to change participants' beliefs and behaviors toward eating disorders and to teach ways to handle the daily struggles of an eating disorder.

12

Eligibility Criteria

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

You may qualify if:

  • Meets diagnostic criteria for AN
  • Medically stable for outpatient treatment. More information on this can be found in the protocol.
  • English literacy

You may not qualify if:

  • Current psychotic illness
  • History of significant brain injury
  • Current dependence on drugs or alcohol
  • Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
  • Previously received CBT or CRT for AN (using the same treatment models as in the study)
  • Ideal body weight of less than 75%
  • Taking psychotropic medications (antidepressants and antipsychotics) unless on a stable dose for 2 months prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • James D. Lock, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 28, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations