Treatment of Hypochondriasis With CBT and/or SSRI

NCT00339079 | Completed Phase 1 Results DMC

• 1 other identifier: R01MH071688
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hypochondriasis

Outcome Measures

Primary Outcomes (1)

• 25% Improvement on Both Whiteley Index and H-YBOCS-M

  Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis

  Measured at Week 24

Secondary Outcomes (1)

• Columbia Heightened Illness Concern - Obsessive-Compulsive Scale

  Not measured

Study Arms (4)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy (CBT)

Placebo

PLACEBO COMPARATOR

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.

Other: Supportive Therapy; Drug: Placebo

Fluoxetine

EXPERIMENTAL

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.

Drug: Fluoxetine; Other: Supportive Therapy

Combined CBT and Fluoxetine

EXPERIMENTAL

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.

Drug: Fluoxetine; Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Fluoxetine DRUG

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.

Also known as: Prozac, Prodep, Sarafem, Lovan, Symbyax, Fluctin

Combined CBT and Fluoxetine; Fluoxetine

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Cognitive Behavioral Therapy (CBT); Combined CBT and Fluoxetine

Supportive Therapy OTHER

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.

Fluoxetine; Placebo

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Columbia Medical Center, New York Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (5)

• Barsky AJ, Ahern DK. Cognitive behavior therapy for hypochondriasis: a randomized controlled trial. JAMA. 2004 Mar 24;291(12):1464-70. doi: 10.1001/jama.291.12.1464.

  PMID: 15039413 BACKGROUND

• Barsky AJ, Wyshak G. Hypochondriasis and somatosensory amplification. Br J Psychiatry. 1990 Sep;157:404-9. doi: 10.1192/bjp.157.3.404.

  PMID: 2245272 BACKGROUND

• Barsky AJ. A 37-year-old man with multiple somatic complaints. JAMA. 1997 Aug 27;278(8):673-9. No abstract available.

  PMID: 9272901 BACKGROUND

• Fallon BA, Ahern DK, Pavlicova M, Slavov I, Skritskya N, Barsky AJ. A Randomized Controlled Trial of Medication and Cognitive-Behavioral Therapy for Hypochondriasis. Am J Psychiatry. 2017 Aug 1;174(8):756-764. doi: 10.1176/appi.ajp.2017.16020189. Epub 2017 Jun 29.

  PMID: 28659038 DERIVED

• Scarella TM, Laferton JA, Ahern DK, Fallon BA, Barsky A. The Relationship of Hypochondriasis to Anxiety, Depressive, and Somatoform Disorders. Psychosomatics. 2016 Mar-Apr;57(2):200-7. doi: 10.1016/j.psym.2015.10.006. Epub 2015 Oct 23.

  PMID: 26785798 DERIVED

MeSH Terms

Conditions

Hypochondriasis

Interventions

Fluoxetine; olanzapine-fluoxetine combination; Cognitive Behavioral Therapy; Palliative Care

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

1\) Limited generalizability since we studied volunteers not medical patients. 2) Sampling bias possible as many subjects sought CBT and were unwilling to take chance of being randomized to medication. 3) Relatively high rates of attrition.

Results Point of Contact

• Title: Arthur J. Barsky, MD
• Organization: Brigham and Women's Hospital

abarsky@partners.org

617-732-5236

Study Officials

• Arthur J. Barsky, MD

  Brigham and Women's Hospital and Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Brian Fallon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Psychiatric Research

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 25, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-03

Locations

US (2)