Trial Outcomes & Findings for Treatment of Hypochondriasis With CBT and/or SSRI (NCT NCT00339079)
NCT ID: NCT00339079
Last Updated: 2017-04-25
Results Overview
Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
195 participants
Primary outcome timeframe
Measured at Week 24
Results posted on
2017-04-25
Participant Flow
The recruitment period was from October 2003 to July 2008. Participants were recruited via advertisements to the general public (e.g., newspaper ads).
Participant milestones
| Measure |
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.
|
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
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
44
|
45
|
53
|
|
Overall Study
COMPLETED
|
20
|
21
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
33
|
23
|
18
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Hypochondriasis With CBT and/or SSRI
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy (CBT)
n=53 Participants
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.
|
Placebo
n=44 Participants
Patients only received placebo pills
|
Fluoxetine
n=45 Participants
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.
|
Combined CBT and Fluoxetine
n=53 Participants
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
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
39.7 years
STANDARD_DEVIATION 14.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 24Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=53 Participants
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.
|
Placebo
n=44 Participants
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
|
Fluoxetine
n=45 Participants
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.
|
Combined CBT and Fluoxetine
n=53 Participants
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.
|
|---|---|---|---|---|
|
25% Improvement on Both Whiteley Index and H-YBOCS-M
|
21 Participants
|
13 Participants
|
20 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Not measuredThe 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.
Outcome measures
Outcome data not reported
Adverse Events
Cognitive Behavioral Therapy (CBT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Fluoxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined CBT and Fluoxetine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Behavioral Therapy (CBT)
n=53 participants at risk
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.
|
Placebo
n=44 participants at risk
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.
|
Fluoxetine
n=45 participants at risk
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.
|
Combined CBT and Fluoxetine
n=53 participants at risk
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.
|
|---|---|---|---|---|
|
Psychiatric disorders
Medication Switch
|
0.00%
0/53 • Adverse event data were continually collected and reported annually when the continuing review was submitted to the human research committee.
|
2.3%
1/44 • Number of events 1 • Adverse event data were continually collected and reported annually when the continuing review was submitted to the human research committee.
|
0.00%
0/45 • Adverse event data were continually collected and reported annually when the continuing review was submitted to the human research committee.
|
0.00%
0/53 • Adverse event data were continually collected and reported annually when the continuing review was submitted to the human research committee.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place