CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 209 enrolled
Drug / intervention
Cognitive behavioral therapy (CBT) for insomnia +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00592449
NCT00592449N/ACompleted

Sleep Disturbance, Central Pain Modulation, and Clinical Pain in Osteoarthritis (The SOAP Study)

Johns Hopkins University·interventional·Posted Jan 14, 2008·Updated May 23, 2019

In Brief

A clinical study evaluating Cognitive behavioral therapy (CBT) for insomnia and Behavioral desensitization treatment for insomnia for Sleep Initiation and Maintenance Disorders and Osteoarthritis. Completed, enrolled 209 participants across 1 site.

Detailed Summary

Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of disability in the world. People with OA frequently experience sleep disturbances, primarily due to pain. Although insomnia is a known consequence of OA, recent studies have shown that it may also worsen clinical pain by interfering with the body's responses to painful stimuli. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will test whether improvement in clinical pain are mediated by changes in certain types of pain processing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2008
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.5 years ago

Interventions

Cognitive behavioral therapy (CBT) for insomniabehavioral

During CBT, participants will learn how to change their sleeping habits and reduce arousal and alertness while trying to sleep. Participants will attend 8 weekly CBT sessions with a psychologist.

Behavioral desensitization treatment for insomniabehavioral

The behavioral desensitization treatment is designed to decondition states of arousal that interfere with sleep. Participants will attend 8 weekly behavioral desensitization treatment sessions with a psychologist.