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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypochondriasis
Interventions Drug: Fluoxetine
Behavioral: Cognitive Behavioral Therapy (CBT)
Other: Supportive Therapy
Drug: Placebo
Enrollment 195
Recruitment Details The recruitment period was from October 2003 to July 2008. Participants were recruited via advertisements to the general public (e.g., newspaper ads).
Pre-assignment Details  
Arm/Group Title Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine
Hide Arm/Group Description 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. 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 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. 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.
Period Title: Overall Study
Started 53 44 45 53
Completed 20 21 27 29
Not Completed 33 23 18 24
Arm/Group Title Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine Total
Hide Arm/Group Description 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. Patients only received placebo pills 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. Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when administered alone in the other arms. Total of all reporting groups
Overall Number of Baseline Participants 53 44 45 53 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 44 participants 45 participants 53 participants 195 participants
39.2  (13.7) 36.4  (12.9) 43.1  (15.9) 40.0  (14.3) 39.7  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 44 participants 45 participants 53 participants 195 participants
Female
24
  45.3%
15
  34.1%
25
  55.6%
21
  39.6%
85
  43.6%
Male
29
  54.7%
29
  65.9%
20
  44.4%
32
  60.4%
110
  56.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 44 participants 45 participants 53 participants 195 participants
Hispanic or Latino
5
   9.4%
3
   6.8%
9
  20.0%
6
  11.3%
23
  11.8%
Not Hispanic or Latino
48
  90.6%
41
  93.2%
36
  80.0%
47
  88.7%
172
  88.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 25% Improvement on Both Whiteley Index and H-YBOCS-M
Hide Description Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis
Time Frame Measured at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine
Hide Arm/Group Description:
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.
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
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.
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.
Overall Number of Participants Analyzed 53 44 45 53
Measure Type: Count of Participants
Unit of Measure: Participants
21
  39.6%
13
  29.5%
20
  44.4%
25
  47.2%
2.Secondary Outcome
Title Columbia Heightened Illness Concern - Obsessive-Compulsive Scale
Hide Description 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.
Time Frame Not measured
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine
Hide Arm/Group Description:

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.

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.

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.

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.

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.

Patients 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.

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.

Supportiv

Patients arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.

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.

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 wi

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were continually collected and reported annually when the continuing review was submitted to the human research committee.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine
Hide Arm/Group Description

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.

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.

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.

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.

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.

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. 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.
All-Cause Mortality
Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/44 (0.00%)      0/45 (0.00%)      0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Behavioral Therapy (CBT) Placebo Fluoxetine Combined CBT and Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      1/44 (2.27%)      0/45 (0.00%)      0/53 (0.00%)    
Psychiatric disorders         
Medication Switch  [1]  0/53 (0.00%)  0 1/44 (2.27%)  1 0/45 (0.00%)  0 0/53 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
1 subject was inadvertently switched from receiving the placebo, to which she had been randomly assigned, to receiving fluoxetine, the active study medication.
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Arthur J. Barsky, MD
Organization: Brigham and Women's Hospital
Phone: 617-732-5236
Responsible Party: Arthur Joseph Barsky III,M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00339079     History of Changes
Other Study ID Numbers: R01MH071688 ( U.S. NIH Grant/Contract )
R01MH071688 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2006
First Posted: June 20, 2006
Results First Submitted: January 12, 2017
Results First Posted: March 3, 2017
Last Update Posted: April 25, 2017