NCT00133601

Brief Summary

This study of cognitive behavioral therapy for insomnia in chronic pain patients is a randomized, controlled clinical trial of parallel groups with three and six months follow up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 16, 2009

Status Verified

January 1, 2009

Enrollment Period

2.7 years

First QC Date

August 19, 2005

Last Update Submit

January 15, 2009

Conditions

InsomniaChronic Pain

Outcome Measures

Primary Outcomes (1)

  • To determine and confirm "prospectively" the severity and frequency of the subjects sleep complaints and as baseline data.

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

CBT-1

Behavioral: Cognitive Behavioral Therapy

2

NO INTERVENTION

Control Group

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

CBT-I including sleep restriction, stimulus control, sleep hygiene instructions and one session of cognitive therapy devoted to catastrophic thoughts about the consequences of insomnia.

1

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages eligible for Study: Over 25 years of age
  • Chronic pain (\>6 months) in the neck and back that has been diagnosed by a physician
  • Insomnia (\>30 minutes to get to sleep, \>30 minutes wake during the night and daytime loss of function due to insomnia and pain)

You may not qualify if:

  • Unstable medical problems
  • Currently undergoing surgery or procedures for their pain or medical problems
  • Head injuries
  • Seizure disorders
  • Taking sleeping pills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Neurophysiology and Sleep Research Laboratory

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersChronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael Perlis, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 23, 2005

Study Start

October 1, 2004

Primary Completion

July 1, 2007

Study Completion

October 1, 2008

Last Updated

January 16, 2009

Record last verified: 2009-01

Locations

US(1)