Trial Outcomes & Findings for Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder (NCT NCT01615367)

Last Updated: 2018-06-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

20 weeks

Results posted on

2018-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	NEW Tx 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.	Treatment as Usual (TAU) 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.
Overall Study STARTED	19	19
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NEW Tx n=19 Participants 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.	Treatment as Usual (TAU) n=19 Participants 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 n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Body Mass Index (BMI)	33.99 kg/m^2 STANDARD_DEVIATION 4.47 • n=5 Participants	36.37 kg/m^2 STANDARD_DEVIATION 6.75 • n=7 Participants	35.18 kg/m^2 STANDARD_DEVIATION 5.78 • n=5 Participants
Weekly Exercise Duration	26.05 minutes STANDARD_DEVIATION 34.50 • n=5 Participants	65.00 minutes STANDARD_DEVIATION 74.99 • n=7 Participants	45.00 minutes STANDARD_DEVIATION 60.33 • n=5 Participants
Montgomery Asberg Depression Rating Scale	13.39 units on a scale STANDARD_DEVIATION 9.06 • n=5 Participants	12.37 units on a scale STANDARD_DEVIATION 9.23 • n=7 Participants	12.86 units on a scale STANDARD_DEVIATION 9.03 • n=5 Participants
Young Mania Rating Scale	5.42 units on a scale STANDARD_DEVIATION 8.55 • n=5 Participants	5.95 units on a scale STANDARD_DEVIATION 5.90 • n=7 Participants	5.68 units on a scale STANDARD_DEVIATION 7.25 • n=5 Participants

PRIMARY outcome

Timeframe: 20 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	NEW Tx n=13 Participants 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.	Treatment as Usual (TAU) n=4 Participants 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.
NEW Tx Scale	23.54 units on a scale Standard Deviation 12.80	37.75 units on a scale Standard Deviation 8.66

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NEW Tx n=13 Participants 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.	Treatment as Usual (TAU) n=8 Participants 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.
Client Satisfaction Questionnaire-8	25.77 units on a scale Standard Deviation 6.88	23.13 units on a scale Standard Deviation 8.11

SECONDARY outcome

Timeframe: 20 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	NEW Tx n=13 Participants 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.	Treatment as Usual (TAU) n=12 Participants 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.
LIFE- Range of Impaired Functioning Tool	9.08 units on a scale Standard Deviation 3.77	9.75 units on a scale Standard Deviation 3.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NEW Tx n=13 Participants 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.	Treatment as Usual (TAU) n=12 Participants 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.
Montgomery Asberg Depression Rating Scale	13.11 units on a scale Standard Deviation 8.89	12.36 units on a scale Standard Deviation 9.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NEW Tx n=13 Participants 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.	Treatment as Usual (TAU) n=12 Participants 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.
Young Mania Rating Scale	5.42 units on a scale Standard Deviation 8.55	5.95 units on a scale Standard Deviation 5.90

SECONDARY outcome

Timeframe: 20 weeks

Body Mass Index levels at post-treatment.

Outcome measures

Outcome measures
Measure	NEW Tx n=12 Participants 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.	Treatment as Usual (TAU) n=11 Participants 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.
Body Mass Index (BMI)	32.49 kg/m^2 Standard Deviation 4.29	35.76 kg/m^2 Standard Deviation 7.51

SECONDARY outcome

Timeframe: 20 weeks

Weekly exercise duration reported at post-treatment.

Outcome measures

Outcome measures
Measure	NEW Tx n=13 Participants 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.	Treatment as Usual (TAU) n=12 Participants 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.
Weekly Exercise Duration	268.08 minutes Standard Deviation 242.72	85.42 minutes Standard Deviation 69.53

Adverse Events

NEW Tx

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment as Usual (TAU)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NEW Tx n=19 participants at risk 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.	Treatment as Usual (TAU) n=19 participants at risk 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.
Surgical and medical procedures Medical Issues (Physical)	26.3% 5/19 • Number of events 5 • 52 weeks	10.5% 2/19 • Number of events 3 • 52 weeks
Injury, poisoning and procedural complications Unrelated Life Events	5.3% 1/19 • Number of events 2 • 52 weeks	5.3% 1/19 • Number of events 2 • 52 weeks
General disorders Worsening Psychiatric Illness	0.00% 0/19 • 52 weeks	5.3% 1/19 • Number of events 1 • 52 weeks

Additional Information

Dr. Louisa Sylvia

Massachusetts General Hospital

Phone: 617-643-4804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place