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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Time Restricted Eating
Other interventionSee arms description
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Time Restrictive Eating ConditionActive comparator 1 intervention
Group B: Waitlist ConditionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Weight Loss
Body weight will be collected in the fasted state using a digital scale (lbs)
Time frame
Week 0, Week 8, Week 20Secondary outcomes
1
Patient Health Questionnaire-9 (PHQ-9)
It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Time frame
Week 0, Week 4, Week 8, Week 202
Generalized Anxiety Disorder scale (GAD-7)
The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item questionnaire that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 has good reliability, criterion, construct, factorial, and procedural validity. The raw score ranges from 0 to 21. Increasing scores are associated with multiple domains of functional impairment. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Time frame
Week 0, Week 4, Week 8 and Week 203
Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality as measure by the Pittsburgh Sleep Quality Index (PSQI) global score. PSQI global score range is 0-21 with higher scores indicating more sleep disturbance. The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% in distinguishing good and poor sleepers.
Time frame
Week 0, Week 4, Week 8, Week 204
Cognitive complaints in bipolar disorder rating assessment (COBRA)
The Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) evaluates cognitive impairments which were perceived in daily living. It consists of 16-items using a 4-point Likert scale as follows for each item: 0 = never, 1 = sometimes, 2 = often, and 3 = always. The COBRA had a one-factor structure and showed high internal consistency.
Time frame
Week 0, Week 4, Week 8, Week 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov