Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|