Viewing Study NCT00106223



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Study NCT ID: NCT00106223
Status: COMPLETED
Last Update Posted: 2012-01-05
First Post: 2005-03-21

Brief Title: Treatment Study Investigating New Cognitive Behavioral Therapy Treatment Manual for Body Dysmorphic Disorder
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: A Randomized Waitlist Controlled Treatment Trial Investigating CBT for Body Dysmorphic Disorder
Status: COMPLETED
Status Verified Date: 2012-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In an earlier phase of this study a cognitive behavioral therapy CBT manual to treat body dysmorphic disorder BDD symptoms was developed We are currently implementing this manual-based treatment to validate its effectiveness in patients with BDD
Detailed Description: BDD is a disease that involves preoccupation with imagined or minor physical flaws The condition often begins in adolescence and if left untreated can cause significant social emotional and occupational distress Within the last decade BDD has received increased attention and various modes of treatment have been utilized and evaluated CBT has been found to be a more effective form of treatment than other types of psychotherapy In this study we have created a new CBT treatment manual and are currently implementing it to evaluate its effectiveness in patients with BDD The utility of this manual for different populations will also be evaluated and adherence and competence measures to assess CBT delivery will be developed

This study will last 24 weeks Participants will be randomly assigned like the flip of a coin to either start CBT treatment immediately or to a waitlist group which would require a 3-month wait without treatment before beginning treatment for this study Participants have a 50-50 chance of being in either group Participants will receive a total of 22 sessions of individual manual-based CBT The CBT sessions will occur weekly during the course of the study During the sessions participants will receive education about BDD and CBT engage in activities that help them confront their BDD learn new ways of thinking about body image and learn relapse prevention techniques Self-report scales will be used to assess participants

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DATR A2-AIR US NIH GrantContract None httpsreporternihgovquickSearchR34MH070490
R34MH070490 NIH None None
2004-P-0004787 None None None