Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
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|ClinicalTrials.gov Identifier: NCT01804907|
Recruitment Status : Completed
First Posted : March 5, 2013
Last Update Posted : April 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Sleep Efficiency||Behavioral: Cognitive Behavioral Therapy Behavioral: Behavioral Modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Cognitive Behavioral Therapy
|Behavioral: Cognitive Behavioral Therapy|
Sham Comparator: Behavioral Modification
Standard sleep hygiene education/desensitization therapy
|Behavioral: Behavioral Modification|
- Sleep Efficiency [ Time Frame: Week 1, 2,3, and 4 ]Patients evaluated weekly for change in sleep efficiency.
- Adherence to HAART [ Time Frame: Week 1, 2,3, and 4 ]Evaluated once weekly for changes in medication adherence.
- Fatigue [ Time Frame: Week 1, 2,3, and 4 ]Changes in reported fatigue levels measured weekly, via the Paper Fatigue Scale (PFS), and the HIV-Related Fatigue Scale (HRFS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804907
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|