Actively Recruiting
Led by Atlanta VA Medical Center · Updated on 2025-09-30
192
Participants Needed
2
Research Sites
17 weeks
Total Duration
A
Atlanta VA Medical Center
Lead Sponsor
V
VA Greater Los Angeles Healthcare System
Collaborating Sponsor
Researchers are evaluating treatments for older adults aged 60 years and above who experience frequent nighttime urination (nocturia) and insomnia. This randomized trial aims to assess the effectiveness of an integrated behavioral therapy combining treatments for both conditions and explore its impact on quality of life. The study addresses a gap in current treatment options by focusing on coexisting nocturia and sleep difficulties in this population. Participants will be randomly assigned to one of two programs. The Integrated Behavioral Therapy Program includes five weekly one-hour sessions, either in-person or via video, plus two telephone check-ins focusing on managing nocturia and insomnia through education, lifestyle changes, and behavioral techniques. The Health Education Program also involves five weekly sessions and two phone calls but covers brain health topics like physical activity, social engagement, sleep changes with aging, and managing medical conditions. Both programs are delivered by an interventionist. During the study, participants will complete two baseline visits, five weekly treatment sessions, a post-intervention assessment, three monthly phone check-ins, and a final assessment four months after treatment. Assessments include questionnaires, blood and urine tests, sleep and urinary symptom diaries, and wearing a wrist actigraph for one week. The main outcome measured is the average frequency of nighttime urination at four months. Additional measures include insomnia severity and nocturia-related quality of life. The total participation lasts about four months with ongoing monitoring and support.
CONDITIONS
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 visits including screening and enrollment visit
Duration - Approximately 6 weeks
Participants undergo 5 weekly one-hour sessions of either Integrated Behavioral Therapy or Health Education Program delivered face-to-face or remotely, followed by 2 telephone check-ins with an interventionist.
5 weekly sessions (in-person or remote) and 2 telephone check-ins
Duration - Approximately 3 months
After the treatment sessions, participants complete a post-intervention assessment and receive monthly phone calls until the final assessment at 4 months.
1 post-intervention visit and 3 monthly 15-minute phone calls plus 1 final assessment visit
Total: 2 locations
1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343
Actively Recruiting
2
Atlanta VAHCS
Atlanta, Georgia, United States, 30033
Actively Recruiting
T
Taressa Sergent
P
Patric Campbell
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Constance H Fung, Courtney J Bolstad, Alison Huang...
https://pubmed.ncbi.nlm.nih.gov/41692807Constance Fung, Courtney J Bolstad, Alison Huang...
https://pubmed.ncbi.nlm.nih.gov/41041560