Combined Behavioral/Pharmacological Therapy for Insomnia
3 other identifiers
interventional
162
1 country
1
Brief Summary
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2001
Longer than P75 for phase_2
1 active site
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
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 3, 2002
CompletedFirst Posted
Study publicly available on registry
September 5, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedSeptember 16, 2013
September 1, 2013
September 3, 2002
September 12, 2013
Conditions
Keywords
Study Arms (3)
Cognitive Behavioral Therapy and Ambien
EXPERIMENTALCognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Placebo
PLACEBO COMPARATORCognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy alone (no drug)
ACTIVE COMPARATORCognitive Behavioral Therapy alone (no drug)
Interventions
Eligibility Criteria
You may qualify if:
- be between 21 and 75 years of age
- have a mean total nocturnal wake time of \> 60 min./night
- have a history of insomnia \> 6 months
- have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by \> 2 hrs. from day to day, or routinely lying in bed awake for periods \> 30 min
You may not qualify if:
- pregnant women
- the terminally ill
- individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep
- individuals with major psychiatric diagnoses
- persons with hypnotic-dependent insomnia
- subjects on antidepressants or anxiolytics
- subjects with evidence of sleep apnea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Duke Sleep Disorders Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2002
First Posted
September 5, 2002
Study Start
September 1, 2001
Study Completion
August 1, 2006
Last Updated
September 16, 2013
Record last verified: 2013-09