Time Restricted Eating (TRE) in Bipolar Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

About this trial

This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.

Eligibility criteria

Qualifiers

Adults (aged 18-65 years)

Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21

Currently experiencing depression (i.e., PHQ-9 ≥ 10)22

Currently overweight (i.e., Body mass index (BMI) > 30 kg/m2)

Disqualifiers

Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)

Concurrent dietary intervention or modification unrelated to study procedures

Severe depression (i.e., PHQ-9>20)

Experiencing manic symptoms (i.e., ASRM < 6)23

Trial design

Treatments tested in this trial

  • Time Restricted Eating

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

Brigham and Women's Hospital

Collaborator