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临床试验/NCT00339079
NCT00339079已完成1 期

Treatment of Hypochondriasis With CBT and/or SSRI

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
195
试验地点
2
主要终点
25% Improvement on Both Whiteley Index and H-YBOCS-M

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)

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.

干预措施: Supportive Therapy (Other)

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.

干预措施: Placebo (Drug)

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.

干预措施: Fluoxetine (Drug)

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.

干预措施: Supportive Therapy (Other)

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.

干预措施: Fluoxetine (Drug)

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.

干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)

结局指标

主要结局

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

时间窗: Measured at Week 24

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

次要结局

  • Columbia Heightened Illness Concern - Obsessive-Compulsive Scale(Not measured)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arthur Joseph Barsky III,M.D.

Vice Chair for Psychiatric Research

Brigham and Women's Hospital

研究点 (2)

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