Healthy Lifestyles for Bipolar Disorder

Browse trials for

• Intermittent Fasting 333
• Bipolar Disorder 1,683

Keywords

• bipolar disorder
• sleep
• circadian rhythm

Intermittent Fasting

333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.

This study's planned enrollment of 300 is above the median of 50 across 320 interventional studies indexed under Intermittent Fasting.

Lead sponsor

University of California, Berkeley is the lead sponsor of 111 studies on the registry; 20 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Study arms

• Experimental
  Time Restricted Eating (TRE) for 8 weeks

  Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window \> 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline.

  Behavioral: Time restricted eating

• Active comparator
  Mediterranean diet for 8 weeks

  Participants will receive a several page introduction to the mediterranean diet, and then will receive support throughout the 8 week intervention to follow this food plan, including brief online psychoeducation that will be sent several times per week, and optional weekly coaching sessions. The mediterranean diet is a plan for healthy eating based on how people eat in the mediterranean region. Individuals will be encouraged to consume vegetables (6 servings/day), fruits (2-4 servings/day), whole grains (daily), legumes (3-4 times per week), nuts (.5 oz per day), and oily fish (2 servings/week). Participants will be encouraged to choose lean meats and other sources of protein over red meat and processed meats. Sweets, refined cereals, alcohol, and wine or alcohol will be labelled as extras, and participants will be encouraged to limit consumption of extras.

  Behavioral: Mediterranean diet

Interventions

• BehavioralTime restricted eating

  Limiting food intake to 10 hours per day

  Also known as: intermittent fasting

• BehavioralMediterranean diet

  Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.

Primary outcomes

1. Acceptability

   Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.

   Time frame: immediately post-treatment (10 weeks after enrollment)

2. Adherence to time-restricted eating

   Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.

   Time frame: Average number of daily food logs showing adherence across the 8-week intervention

3. Adherence to Mediterranean Diet

   Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.

   Time frame: Average number of food logs showing adherence at or above the median for 2 days at the mid-point of treatment (week 6) and at the end of treatment (week 10)

4. Mania

   Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater

   Time frame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline

5. Depression

   Decline in Montgomery Asberg Depression Scale (MADRS) total scores, completed by a blind rater

   Time frame: Lower MADRS at the end of intervention (10 weeks) as compared to baseline

6. Self-rated Quality of Life (QOL)

   Higher scores on the self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) at 1.5-months post intervention as compared to baseline

   Time frame: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline

7. Mania at follow-up

   Sustained lower YMRS scores across follow-up

   Time frame: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

8. Depression at follow-up

   Sustained lower MADRS scores across follow-up

   Time frame: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

9. QOL at follow-up

   Sustained higher Brief QOL.BD scores

   Time frame: Brief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline

Secondary outcomes

1. Self-rated mania

   Lower Patient Health Questionnaire (PHQ) Mania scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention

   Time frame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline

2. Self-rated depression

   Lower Patient Health Questionnaire (PHQ) Depression scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention

   Time frame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline

3. Sleep hygiene behaviors

   Lower scores on the Sleep Household Environment and In-Bed Behaviors at end-of-treatment (10 weeks) as compared to baseline

   Time frame: post-intervention (10 weeks) as compared to baseline

4. Weekly change in mania severity

   Lower Longitudinal Interval Follow-up Evaluation (LIFE) weekly Mania scores post-treatment as compared to those at baseline. The investigators will administer the LIFE interview at 3, 6, and 12-months after the intervention, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until one year after the intervention ends.

   Time frame: Weekly scores from the end of the intervention through one-year post-intervention follow-up

5. Sleep disturbance and sleep impairment

   Lower scores on the Patient Outcomes Reporting Information System (PROMIS) sleep disturbance and sleep impairment scores at post-treatment (10 weeks) as compared to baseline

   Time frame: post-treatment (10 weeks) as compared to baseline

6. Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ)

   MCTQ scores will show a smaller proportion of individuals with either early or delayed chronotype (as reflected in standard scoring for the MCTQ) at post-treatment as compared to baseline

   Time frame: post-treatment (10 weeks) as compared to baseline

7. Regularity of daily routines (Brief Social Rhythm Questionnaire)

   Lower Brief Social Rhythm Questionnaire scores (less irregularity) at post-treatment as compared to baseline

   Time frame: post-treatment (10 weeks) as compared to baseline

8. Daily emotional lability as assessed using ecological momentary assessment

   Lower mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at the mid-point of treatment (6 weeks) as compared to baseline. Participants will be asked to complete negative affect ratings several times per day for 8 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 8 days at baseline and at treatment mid-point.

   Time frame: mid-point of treatment (6 weeks post study entry) as compared to baseline

Publications

• Johnson SL, Murray G, Kriegsfeld LJ, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Joyner KJ, Villanueva R, Michalak EE. A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 May 18;24(1):374. doi: 10.1186/s12888-024-05790-4. PubMed 38762486 ↗

Individual participant data

Plan to share: Yes — Measures, data, and analysis scripts will be shared through Open Science Foundation.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: De-identified data will be shared within one year after data collection ends.

Access criteria: Data will be available publically through Open Science Foundation upon request. We will also comply with Wellcome Trust guidance for data sharing.