Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339079
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2006-06-16
Brief Title:
Treatment of Hypochondriasis With CBT andor SSRI
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Treatment of Hypochondriasis With CBT andor SSRI
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This study will compare the effectiveness of cognitive behavioral therapy antidepressant medication and a combination of the two for treating hypochondriasis
Detailed Description:
Hypochondriasis is one of the most difficult psychiatric disorders to treat People with hypochondriasis believe that real or imagined physical symptoms are signs of serious illnesses despite medical reassurance and other evidence to the contrary Symptoms of the disorder include a preoccupation with fear of an illness a persistent fear of having a serious illness despite medical reassurance and misinterpretation of symptoms Some individuals with hypochondriasis recognize that their fear of having a serious illness may be excessive unreasonable or unfounded Episodes of hypochondriasis usually last from months to years with equally long periods of remission Cognitive behavioral therapy CBT and the antidepressant drug fluoxetine FLX have both been shown to be effective treatments for hypochondriasis However the relative efficacy of a combined approach has yet to be determined This study will compare the effectiveness of cognitive behavioral therapy antidepressant medication and a combination of the two for treating hypochondriasis
Participants in this double-blind study will first report to the study site for two sessions to determine eligibility for participation Eligible individuals will then be randomly assigned to receive one of the following four treatments for 12 weeks CBT only FLX only CBT plus FLX or a placebo pill All participants receiving medication will also receive supportive therapy Treatment response will be assessed at Week 12 and participants who have shown improvement will continue in the study for an additional 12 weeks Participants who have not responded to treatment will be removed from the study and will receive open treatment Participants assigned to receive medication or placebo will take medication once daily for the full 24 weeks Participants assigned to CBT only or CBT plus FLX will receive CBT weekly for the first 8 weeks then biweekly until Week 12 and then monthly until week 24 Outcomes will be assessed at study visits at Weeks 6 12 24 and 48 and over the phone at Week 36
Participants in this double-blind study will first report to the study site for two sessions to determine eligibility for participation Eligible individuals will then be randomly assigned to receive one of the following four treatments for 12 weeks CBT only FLX only CBT plus FLX or a placebo pill All participants receiving medication will also receive supportive therapy Treatment response will be assessed at Week 12 and participants who have shown improvement will continue in the study for an additional 12 weeks Participants who have not responded to treatment will be removed from the study and will receive open treatment Participants assigned to receive medication or placebo will take medication once daily for the full 24 weeks Participants assigned to CBT only or CBT plus FLX will receive CBT weekly for the first 8 weeks then biweekly until Week 12 and then monthly until week 24 Outcomes will be assessed at study visits at Weeks 6 12 24 and 48 and over the phone at Week 36
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 |
|---|---|---|---|
| R01MH071688 | NIH | None | httpsreporternihgovquickSearchR01MH071688 |