Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01615367
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in bipolar disorder, yet no empirically validated psychosocial interventions to manage risk factors for CVD in BD have been developed. The purpose of this study is to develop and test the feasibility of an integrated treatment to decrease CVD risk factors, while exploring whether the intervention improves overall functioning and mood symptoms. The designed treatment integrates theories on Nutrition strategies, Exercise interventions, and Wellness Treatment (NEW Tx) to address risk factors for CVD that co-occur with bipolar disorder. NEW Tx includes novel intervention strategies in each of these three modules, as well as modified and tailored empirically-supported strategies for bipolar disorder. The primary hypotheses are that NEW Tx will be feasible to deliver, acceptable to this population, and associated with improvements in CVD risk factors (i.e., waist circumference). Exploratory analyses will examine predictors of treatment response and the effect of NEW Tx on mood symptoms and overall functioning.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Other: Nutrition, Exercise, and Wellness (NEW) psychotherapy; Drug: Typically consists of at least one FDA-approved mood stabilizer	Phase 1/Phase 2

Detailed Description

The purpose of the Nutrition, Exercise, and Wellness Treatment (NEW Tx) research is to develop and test the feasibility and acceptance of a theoretically integrated treatment to address the impact of medical comorbidity of individuals with bipolar disorder (BD), while exploring its efficacy, whether it improves overall functioning and symptoms, as well as examine a potential moderator and mediator of treatment response.

A.Primary Aims

Aim 1: Feasibility and Acceptance of NEW Tx in the Nonrandomized Trial.

Hypothesis 1a: A preliminary study of whether NEW Tx will be feasible with regards to recruitment, retention, blinded assessments, and therapist adherence to NEW Tx.

Hypothesis 1b: Participants will report high satisfaction with the treatment and acceptability over the study duration in a nonrandomized trial.

Aim 2: Feasibility and Acceptance of NEW Tx and its Evaluation in the Randomized Pilot Trial.

Hypothesis 2a: A pilot study of whether NEW Tx will be feasible with regards to recruitment, randomization, retention, blinded assessments, and therapist adherence to NEW Tx.

Hypothesis 2b: Participants will report high satisfaction with the treatment and acceptability over the study duration in the randomized pilot trial.

1. Exploratory Aims

Aim 3a: Reducing Medical Burden in the Randomized Pilot Trial. Pilot test the efficacy of NEW Tx in improving medical burden using the Framingham Risk Score (FRS).

Hypothesis 3a: Over the course of 20-weeks (18 sessions) the NEW Tx group will have a lower FRS compared to treatment as usual (TAU) in the randomized pilot trial.

Aim 3b: Symptoms and Functioning in the Randomized Pilot Trial. Examine the efficacy of NEW Tx in improving functioning and symptoms of BD.

Hypothesis 3b: Over the course of 20-weeks (18 sessions) the NEW Tx group will improved functioning and mood symptoms compared to TAU in the randomized pilot trial.

Aim 3c: Moderator and Mediator of NEW Tx in the Randomized Pilot Trial. Investigate a potential moderator and mediator of treatment response.

Hypothesis 3c.1: Individuals with higher baseline Body Mass Index (BMI) > 30 will moderate the between treatment effect size for medical burden (FRS) in the randomized pilot trial, such that of NEW Tx will have lower FRSs.

Hypothesis 3c.2: Mastery of the diet and exercise modules of NEW Tx will mediate the association of NEW Tx and improvement in medical burden (FRS).

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
• Actual Study Start Date: May 21, 2012
• Actual Primary Completion Date: Feb 28, 2017
• Actual Study Completion Date: Feb 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NEW Tx 25 people will be randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.	Other: Nutrition, Exercise, and Wellness (NEW) psychotherapy; NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.
Active Comparator: Treatment as usual (TAU) 25 people will be randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.	Drug: Typically consists of at least one FDA-approved mood stabilizer; Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.

Outcome Measures

Primary Outcome Measures

1. NEW Tx Scale [20 weeks]

   NEW Tx Scale is a 10-item scale to asses participants' expectations of NEW Tx their acceptability of NEW Tx at Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx. The scale for this item is a 5-point Likert scale ranging from 1 ("strongly agree") to 5 ("strongly disagree"). The score for each item is summed for a total score that ranges from 10 to 50 with higher scores indicating poorer perception of the treatment. TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.

2. Client Satisfaction Questionnaire-8 [20 weeks]

   Client Satisfaction Questionnaire-8 is a reliable and valid self-report of participants' acceptability of treatment. This is an assessment of client/patient satisfaction with their care and perceived quality and tolerability of NEW Tx. The scale for this item is a 4-point Likert scale ranging from 1 ("poor") to 4 ("excellent"). The score for each item is summed for a total score that ranges from 8 to 32 with higher scores indicating greater acceptability of the treatment.TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.

Secondary Outcome Measures

1. LIFE- Range of Impaired Functioning Tool [20 weeks]

   LIFE- Range of Impaired Functioning Tool assesses the extent to which medical burden has impacted current functioning. The score for each domain is summed for a total score that ranges from 4 to 20 with higher scores indicating worse functioning.

2. Montgomery Asberg Depression Rating Scale [20 weeks]

   Montgomery Asberg Depression Rating Scale is a 10-item clinician-rated measure of depression that assesses the presence and severity of patient's current depressive symptoms. The score for each item is summed for a total score that ranges from 0 to 60 with higher scores indicating more severe current depressive symptoms.

3. Young Mania Rating Scale [20 weeks]

   Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient's current symptoms of mania. The score for each item is summed for a total score that ranges from 0 to 56 with higher scores indicating more severe current manic symptoms.

4. Body Mass Index (BMI) [20 weeks]

   Body Mass Index levels at post-treatment.

5. Weekly Exercise Duration [20 weeks]

   Weekly exercise duration reported at post-treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of Bipolar Disorder (Type I or II), which is the primary focus of treatment

• Ability to give informed consent

• Currently ill (CGI-BP ≥ 3)

• Age > 18 years and < 65 years

• Overweight individuals (BMI > 25)

Exclusion Criteria:

• Unwilling/unable to comply with study procedures

• Endorsed item, confirmed by patient's physician, on the PAR-Q

• Euthymic (CGI-BP < 3)

• Diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa) in the past month

• Diagnosis of substance dependence in the past month

• Active suicidality (MADRS item 9 score > 4)

• Pregnant (as analyzed by a urine pregnancy test)

• Currently receiving another psychosocial treatment

• Exercising regularly (i.e., 5 days per week for 30 min)

• Neurologic disorder or history of head trauma

• Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 28, 2014

More Information

Publications

None provided.

• Responsible Party: Louisa Grandin Sylvia, Instructor of Psychiatry, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01615367
• Other Study ID Numbers: K23MH091182-02
• First Posted: Jun 8, 2012
• Last Update Posted: Jun 7, 2018
• Last Verified: May 1, 2018

• Keywords provided by Louisa Grandin Sylvia, Instructor of Psychiatry, Massachusetts General Hospital: Bipolar disorder; Nutrition; Exercise; Symptoms; Functioning
• Additional relevant MeSH terms: Disease; Bipolar Disorder

Study Results

Participant Flow

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer. Participants randomized to TAU who complete the first 20 weeks of the study will have the option to receive NEW Tx. TAU participants who chose to receive NEW Tx (the waitlist group) will follow the same procedures as the NEW Tx group over an additional 20 weeks. Assessment data was collected but not analyzed.
Period Title: Overall Study
STARTED	19	19
COMPLETED	14	13
NOT COMPLETED	5	6

Baseline Characteristics

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)	Total
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.	Total of all reporting groups
Overall Participants	19	19	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 100%	18 94.7%	37 97.4%
>=65 years	0 0%	1 5.3%	1 2.6%
Sex: Female, Male (Count of Participants)
Female	13 68.4%	12 63.2%	25 65.8%
Male	6 31.6%	7 36.8%	13 34.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.3%	4 21.1%	5 13.2%
Not Hispanic or Latino	17 89.5%	14 73.7%	31 81.6%
Unknown or Not Reported	1 5.3%	1 5.3%	2 5.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 5.3%	0 0%	1 2.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 5.3%	0 0%	1 2.6%
White	16 84.2%	16 84.2%	32 84.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 5.3%	3 15.8%	4 10.5%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	33.99 (4.47)	36.37 (6.75)	35.18 (5.78)
Weekly Exercise Duration (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	26.05 (34.50)	65.00 (74.99)	45.00 (60.33)
Montgomery Asberg Depression Rating Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.39 (9.06)	12.37 (9.23)	12.86 (9.03)
Young Mania Rating Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.42 (8.55)	5.95 (5.90)	5.68 (7.25)

Outcome Measures

1. Primary Outcome

Title	NEW Tx Scale
Description	NEW Tx Scale is a 10-item scale to asses participants' expectations of NEW Tx their acceptability of NEW Tx at Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx. The scale for this item is a 5-point Likert scale ranging from 1 ("strongly agree") to 5 ("strongly disagree"). The score for each item is summed for a total score that ranges from 10 to 50 with higher scores indicating poorer perception of the treatment. TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Participants in the treatment as usual condition were not required to complete this assessment if they did not elect to complete the NEW Tx intervention following the waitlist period. Participants completed this survey at the post-treatment visit only. Results only includes data from participants who completed the treatment and had data to report.

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Measure Participants	13	4
Mean (Standard Deviation) [units on a scale]	23.54 (12.80)	37.75 (8.66)

2. Primary Outcome

Title	Client Satisfaction Questionnaire-8
Description	Client Satisfaction Questionnaire-8 is a reliable and valid self-report of participants' acceptability of treatment. This is an assessment of client/patient satisfaction with their care and perceived quality and tolerability of NEW Tx. The scale for this item is a 4-point Likert scale ranging from 1 ("poor") to 4 ("excellent"). The score for each item is summed for a total score that ranges from 8 to 32 with higher scores indicating greater acceptability of the treatment.TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Participants in the treatment as usual condition were not required to complete this assessment if they did not elect to complete the NEW Tx intervention following the waitlist period. Participants completed this survey at the post-treatment visit only. Results only includes data from participants who completed the treatment and had data to report.

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Measure Participants	13	8
Mean (Standard Deviation) [units on a scale]	25.77 (6.88)	23.13 (8.11)

3. Secondary Outcome

Title	LIFE- Range of Impaired Functioning Tool
Description	LIFE- Range of Impaired Functioning Tool assesses the extent to which medical burden has impacted current functioning. The score for each domain is summed for a total score that ranges from 4 to 20 with higher scores indicating worse functioning.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Measure Participants	13	12
Mean (Standard Deviation) [units on a scale]	9.08 (3.77)	9.75 (3.33)

4. Secondary Outcome

Title	Montgomery Asberg Depression Rating Scale
Description	Montgomery Asberg Depression Rating Scale is a 10-item clinician-rated measure of depression that assesses the presence and severity of patient's current depressive symptoms. The score for each item is summed for a total score that ranges from 0 to 60 with higher scores indicating more severe current depressive symptoms.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Measure Participants	13	12
Mean (Standard Deviation) [units on a scale]	13.11 (8.89)	12.36 (9.23)

5. Secondary Outcome

Title	Young Mania Rating Scale
Description	Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient's current symptoms of mania. The score for each item is summed for a total score that ranges from 0 to 56 with higher scores indicating more severe current manic symptoms.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Measure Participants	13	12
Mean (Standard Deviation) [units on a scale]	5.42 (8.55)	5.95 (5.90)

6. Secondary Outcome

Title	Body Mass Index (BMI)
Description	Body Mass Index levels at post-treatment.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Measure Participants	12	11
Mean (Standard Deviation) [kg/m^2]	32.49 (4.29)	35.76 (7.51)

7. Secondary Outcome

Title	Weekly Exercise Duration
Description	Weekly exercise duration reported at post-treatment.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.

Arm/Group Title	NEW Tx	Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.	19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
Measure Participants	13	12
Mean (Standard Deviation) [minutes]	268.08 (242.72)	85.42 (69.53)

Adverse Events

Time Frame	52 weeks
Arm/Group Title	NEW Tx		Treatment as Usual (TAU)
Arm/Group Description	19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.		19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
All Cause Mortality
	NEW Tx		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	NEW Tx		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	NEW Tx		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/19 (26.3%)		3/19 (15.8%)
General disorders
Worsening Psychiatric Illness	0/19 (0%)	0	1/19 (5.3%)	1
Injury, poisoning and procedural complications
Unrelated Life Events	1/19 (5.3%)	2	1/19 (5.3%)	2
Surgical and medical procedures
Medical Issues (Physical)	5/19 (26.3%)	5	2/19 (10.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.