Comparing Cognitive Behavioral Therapy, Antidepressant Medication, and Combined Treatment in Individuals With Hypochondriasis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arthur Joseph Barsky III,M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00339079
First received: June 16, 2006
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

This study will compare the effectiveness of cognitive behavioral therapy, antidepressant medication, and a combination of the two for treating hypochondriasis.


Condition Intervention Phase
Hypochondriasis
Drug: Fluoxetine
Behavioral: Cognitive Behavioral Therapy
Other: Supportive Therapy
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Hypochondriasis With CBT and/or SSRI

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Whiteley Index [ Time Frame: Measured at Weeks 6, 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Columbia Heightened Illness Concern - Obsessive-Compulsive Scale [ Time Frame: Measured at Weeks 6, 12, 24 and 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heightened Illness Concern Severity Scale [ Time Frame: Measured at Weeks 24, 36, and 48 ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory [ Time Frame: Baseline, Weeks 6, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
  • Beck-II Depression Inventory [ Time Frame: Intake, baseline, Weeks 6, 12, 24, 36, 48 ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cognitive behavior therapy (CBT) alone
Behavioral: Cognitive Behavioral Therapy
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.
Placebo Comparator: 4
Placebo pill
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.
Experimental: 2
Fluoxetine alone
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: 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.
Experimental: 3
Combined CBT and fluoxetine (SSRI)
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.
Behavioral: Cognitive Behavioral Therapy
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) (Use of zolpidem or similar non-benzodiazepine hypnotics will be allowed).
  • 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:

A) Taking psychoactive medications for psychiatric indications (i.e., DSM-IV psychiatric disorders) who prefer not to discontinue these medications or for whom discontinuation would be clinically inadvisable B) Taking medications that may interact adversely with fluoxetine: theophylline, certain anti-arrhythmic, warfarin, codeine, monoamine oxidase inhibitors, coumadin, digitoxin, flecainide, linazeline (Zyvox), or vinblastine C) This will not prevent participants taking stable doses for at least three months of medications prescribed for non-psychiatric indications, e.g. antidepressants for chronic pain, sedating antidepressants or anti-anxiety agents for insomnia, anti-convulsants for pain, from participating in the study. Participants will be allowed to remain on propanol during this study but will have their blood pressure and pulse monitored every four weeks. Use of tricyclic drugs concomitantly will result in exclusion from the study, unless the dose of tricyclic drugs is low (i.e., 10 mg for patients on doxepin or amitriptyline for sleep). Ascertained by patient report and the judgment of the study psychiatrist.

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339079

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Columbia Medical Center, New York Psychiatric Institute
New York City, New York, United States, 10032
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Arthur J. Barsky, MD Brigham and Women's Hospital and Harvard Medical School
Principal Investigator: Brian Fallon, MD Columbia University
  More Information

Additional Information:
Publications:
Responsible Party: Arthur Joseph Barsky III,M.D., Vice Chair for Psychiatric Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00339079     History of Changes
Other Study ID Numbers: R01 MH071688, R01MH071688, DSIR 83-ATAS
Study First Received: June 16, 2006
Last Updated: August 14, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypochondriasis
Somatoform Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014