Better Sleep for Bipolar Disorder

Individuals may be eligible to participate if they:

• Are 18 to 60 years old
• Have bipolar disorder type I or type II
• Have a later sleep schedule or "evening chronotype," meaning your body naturally prefferes to sleep and wake later
• Have been taking any psychotropic medications at a stable dose for the past month
• Have been feeling down, sad or blue
• Are not pregnant or breastfeeding, if you are able to become pregnant
• Agree to use contraception during the study, if you are able to become pregnant

If you agree to participate in the Better Sleep for Bipolar Disorder study, the study team will email you screening questionnaires to complete online. The questionnaires will ask about demographics, current medications, medical history, substance use, sleep and daytime functioning. Completing the screening questionnaires will take approximately 15-30 minutes.

Individuals who are eligible to continue the screening process after completing the questionnaires will be scheduled for one or two virtual screening interview(s) using secure videoconferencing. 

If you are not a participant in the Prechter Longitudinal Study of Bipolar Disorder, you will complete a diagnostic screening to confirm you meet criteria for bipolar disorder I or II. During this interview, individuals will be asked questions about their psychiatric history and current symptoms. This screening interview will take approximately 60-120 minutes to complete. 

Individuals will then meet with a member of the study team for a second interview. The study team will ask questions about current mood, complete a suicide risk assessment and a sleep interview. This screening interview will take approximately 30-45 minutes to complete. 

Participants will meet with a member of the study team at the Sleep and Circadian Research Lab located within the Rachel Upjohn Building in Ann Arbor, Michigan. Participants will pick up study materials, download mobile apps and schedule future study visits. Parking is free at the Rachel Upjohn Building.

During Lab Visit 1, you will:

• Set up the Fitbit device you will be wearing during the day and night for the remainder of the study
• Review the process for completing the daily sleep-wake diary
• Download and set up the MyDataHelps app on your smartphone
• Schedule all future study visits
• Pick up materials to complete the Better Sleep for Bipolar Disorder study (saliva collection kit, study binder and study tablets)
• Females of childbearing potential will also complete a urine pregnancy screen 

After Lab Visit 1, participants will begin the baseline phase of the study. This phase lasts approximately one week and is completed virtually. 

During baseline, you will: 

• Complete online questionnaires about your sleep and mood
• Meet virtually with a study team member who will complete a mood and suicide risk assessment with you (15-20 minutes)
• Meet virtually with a study team member to review the in-home saliva collection procedures in detail (30-60 minutes)
• Complete the first in-home saliva collection

Individuals participating in this study will provide saliva samples to the research team. The team will use saliva samples to study the levels of the hormone melatonin. Participants are provided detailed instructions and materials for the in-home saliva collection during Lab Visit 1. 

Participants will collect their saliva sample once at the beginning of the study, and again at the end of the study. Participants will store their saliva samples in their freezer until study completion, when materials are dropped off with the study team at Lab Visit 2. 

Individuals participating in the Better Sleep for Bipolar Disorder study will be randomly assigned to receive either a low-dose melatonin (0.5mg) tablet and or a placebo tablet. 

Participants will begin taking the daily melatonin (0.5 mg) or placebo tablets following the baseline phase, and will continue taking the melatonin or placebo tablet until the end of the study (approximately 4 weeks). Participants will receive specific instructions from a study team member when to take the melatonin or placebo tablet.

The morning after Lab Visit 1, participants will begin filling out a sleep-wake diary daily for the remainder of the study. The daily diary will take less than 5 minutes and will be completed online.

The day after Lab Visit 1, the MyDataHelps app will send study participants notifications at three different times (morning, afternoon and evening) every day to complete a brief survey. The surveys will take approximately 1-2 minutes to complete and will ask you about the emotions and feelings you were experiencing the moment you were alerted to complete the survey.

Participants will virtually meet with a study team member for 15-30 minutes every week. During each meeting, the study team will:

• Review your sleep diary and Fitbit sleep data
• Review any side effects from the melatonin or placebo tablet and time you took the tablet
• Talk to you about your sleep
• Provide your with an electronic handout summarizing your instructions for the next week of the study

Participants will meet with a member of the study team at the Rachel Upjohn Building in Ann Arbor, Michigan. During Lab Visit 2, you will return all the study materials and your saliva samples from both in-home collections.

Study participation ends once participants have completed the second saliva collection and the post-study questionnaires.

Participants will be paid up to $530 for completing all aspects of the Better Sleep for Bipolar Disorder study. 

• Screening Phase (up to $30):
  • Screening questionnaires: $5
  • Screening interview 1 (diagnostic screening): $20
  • Screening interview 2: $5
• Intervention Phase (up to $500):
  • Saliva collection: $125 per collection (2 collection days X $125 = $250)
  • $60 for weeks 1, 2, and 3 for completing daily sleep-wake diary, daily surveys, wearing the Fitbit, and attending the weekly virtual meetings (3 weeks X $60 = $180)
• $70 for completing week 4 for completing daily sleep-wake diary, daily surveys, wearing the Fitbit, attending the weekly virtual meeting, and completing post-study questionnaires (1 week X $70 = $70)

Participants will have the option to be paid by:

• Check (mailed)
• Voucher which may be redeemed for cash at the University of Michigan’s cashier office (located on central campus and the main hospital)
• Gift Card (mailed)