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Trial record 4 of 12 for:    "Somatoform Disorder" | "Serotonin Agents"

Treatment of Hypochondriasis With CBT and/or SSRI

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ClinicalTrials.gov Identifier: NCT00339079
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : March 3, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Arthur Joseph Barsky III,M.D., Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE June 16, 2006
First Posted Date  ICMJE June 20, 2006
Results First Submitted Date  ICMJE January 12, 2017
Results First Posted Date  ICMJE March 3, 2017
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE June 2006
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2017)
25% Improvement on Both Whiteley Index and H-YBOCS-M [ Time Frame: Measured at Week 24 ]
Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
  • Measured at Weeks 24, 36, and 48: Clinical Global Impressions Scale
  • Columbia Heightened Illness Concern - Obsessive-Compulsive Scale
Change History Complete list of historical versions of study NCT00339079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
Columbia Heightened Illness Concern - Obsessive-Compulsive Scale [ Time Frame: Not measured ]
The Columbia Heightened Illness Concern - Obsessive-Compulsive Scale was the name for an earlier version of the H-YBOCS-M. The H-YBOCS-M is an expanded version and has additional items not included in the Columbia Heightened Illness Concern OCS. We did not administer the CHIC-OCS to patients in this study.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
  • Measured at Weeks 24, 36, and 48: Heightened Illness Concern Severity Scale
  • Whiteley Index
  • State-Trait Anxiety Inventory
  • Beck-II Depression Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hypochondriasis With CBT and/or SSRI
Official Title  ICMJE Treatment of Hypochondriasis With CBT and/or SSRI
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypochondriasis
Intervention  ICMJE
  • Drug: Fluoxetine
    Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.
    Other Names:
    • Prozac
    • Prodep
    • Sarafem
    • Lovan
    • Symbyax
    • Fluctin
  • Behavioral: Cognitive Behavioral Therapy (CBT)
    CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length.
  • Other: Supportive Therapy
    The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.
  • Drug: Placebo
    Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter.
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Therapy (CBT)
    Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
    Intervention: Behavioral: Cognitive Behavioral Therapy (CBT)
  • Placebo Comparator: Placebo
    Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
    Interventions:
    • Other: Supportive Therapy
    • Drug: Placebo
  • Experimental: Fluoxetine
    Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
    Interventions:
    • Drug: Fluoxetine
    • Other: Supportive Therapy
  • Experimental: Combined CBT and Fluoxetine
    Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
    Interventions:
    • Drug: Fluoxetine
    • Behavioral: Cognitive Behavioral Therapy (CBT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2017)
195
Original Enrollment  ICMJE
 (submitted: June 16, 2006)
132
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Meets DSM-IV criteria for hypochondriasis; ascertained by Structured Diagnosis for Hypochondriasis module of SCID-I, and meets a hypochondriasis severity rating of at least "moderate".
  • Drug free for 6 weeks of all psychoactive or investigational medications (seven weeks for fluoxetine).
  • Approval from treating physician if concomitant psychoactive medications need to be withdrawn prior to study participation.
  • English fluency and literacy.

Exclusion Criteria

  • Pregnant or nursing mothers and women of childbearing potential who are not taking adequate birth control precautions.
  • Any of the following Axis I mental disorders: chronic pain syndrome, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, alcohol abuse or dependence disorder (current or within the last six months), or substance abuse or dependence disorder (current or within the last twelve months). Patients with other comorbid psychiatric disorders are eligible based on the following three criteria: hypochondriasis must be the predominant presenting disorder; patient can not have a major co-morbid psychiatric disorder rated as "severe" on the Clinical Global Impressions Scale (CGI Scale); and patients can not have a co-morbid psychiatric disorder that causes significant functional impairment (significant functional impairment will be defined as an impairment that interferes in a marked way with expected role functioning, vocational and/or interpersonal).
  • Suicidality within the last 6 months as established by a score of 9 or more on the suicidality module of the MINI Plus.
  • Symptom-contingent pending litigation, disability compensation, or workers' compensation proceedings
  • Major medical illness expected to worsen significantly, lead to hospitalization, or likely to prove fatal in the next six months, established with the Cumulative Illness Rating Scale (CIRS); Stable, chronic medical illness is not an exclusion criterion
  • Not able to withdraw from concomitant psychoactive medications or currently taking necessary other medication that might interact adversely with fluoxetine:
  • Clinically important abnormalities in ECG, laboratory tests (including thyroid function) or physical examination. "Clinically important" abnormalities are those that signify a treatment intervention is needed or a medical abnormality has not been sufficiently addressed. Patients with medical problems that are stable and chronic are eligible, but patients with medical problems that are unstable, acute, or inadequately evaluated will be excluded. A current electrocardiogram is required for all patients with symptoms suggestive of cardiac disease, including chest pain, dyspnea, palpitations, or lightheadedness; if no current electrocardiogram exists, the study will obtain one.
  • History of severe side effects associated with fluoxetine or noncompliance with prior CBT for hypochondriasis
  • Previous adequate trial of either fluoxetine (eight weeks of which two weeks were at a minimum dose of 60 mg/day) or CBT for hypochondriasis (at least four sessions specifically targeting hypochondriacal symptoms) will be excluded, regardless of prior response. Inability to ambulate or mobility restrictions that prohibit frequent travel to the hospital for treatment and evaluation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00339079
Other Study ID Numbers  ICMJE R01MH071688( U.S. NIH Grant/Contract )
R01MH071688 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arthur Joseph Barsky III,M.D., Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Arthur J. Barsky, MD Brigham and Women's Hospital and Harvard Medical School
Principal Investigator: Brian Fallon, MD Columbia University
PRS Account Brigham and Women's Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP