Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation

1

• Randomized Trial of Achieving Healthy Lifestyles
  in Psychiatric Rehabilitation
• ACHIEVE Trial
• NCT00902694, R01MH080964
• Society for Clinical Trials Annual Meeting
• May 20, 2014

Gail L. Daumit Nae-Yuh Wang Joseph Gennusa Stacy
Goldsholl Jeff Richardson
2
Disclosures

• No Relevant Financial Relationships with
  Commercial Interests

3
Presentation Overview

• Context and trial overview
• Design and analysis
• Recruitment, data collection, retention
• Weight-loss intervention
• View from community mental health programs

• Gail Daumit, PI
• Nae-Yuh Wang, Statistician
• Joseph Gennusa, Project Director
• Stacy Goldsholl, Intervention Director
• Jeff Richardson, Executive Director, Mosaic
  Community Services, Inc.

4
Serious Mental Illness (SMI)

• Schizophrenia, bipolar disorder or disabling
  depression
• 5.4 of U.S. adults, 1.1 schizophrenia, 2
  bipolar
• Generally require continuous, long term
  psychotropic medications
• Medicaid, Medicare, public assistance recipients,
  high health care utilization
• Comorbid substance use 50

5
Cause of Death Comparing Maryland Medicaid SMI
with Maryland Population (1999-2001)
SMI Deaths per 100,000 person years
All-Cause Mortality (1975.3)
Heart Disease (585.5)
Malignant Neoplasm (340.4)
HIV (131.7)
Diabetes Mellitus (118.0)
Cerebrovasc. Disease (110.9)
Chronic Lung Disease (108.8)
Influenza/Pneumonia (103.4)
Septicemia (85.8)
Renal Disease (64.6)
Accidental (e.g., suicide) (37.2)
Standardized Mortality Ratio (SMR)
SMI severe mental illness.

Adjusted for
age, gender, and race death rate per 100,000
persons in Maryland Medicaid SMI. Daumit GL et
al., Psychiatric Research, in press
6
Contributors to Premature Mortality

• Cardiovascular disease risk factors
• Health risk behaviors obesity, physical
  inactivity, tobacco smoking
• Health risk factors diabetes and glucose
  control, hypertension, hyperlipidemia
• Cancer, Chronic Lung Disease, Liver Disease, HIV
• Health care quality

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Overweight and Obesity in Serious Mental Illness
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Comparison of Prevalence of Overweight and
Obesity in U.S. Sample and Psychiatric
Rehabilitation Program Attendees, (95 CI)
    SMI NHANES
All   n873 n5926
All Overweight or obesity 85 (83 ,87) 73 (70,76)
All Obesity 60 (57,64) 40 (37,43)
All Extreme obesity 16 (14,19) 8.4 (7.2,9.5)
Men   n535 n2889
Men Overweight or obesity 84 (80,87) 74 (70,78)
Men Obesity 54 (50,58) 38 (33, 42)
Men Extreme obesity 10 (8,13) 6 (5, 7)
Women n338 n3037
Women Overweight or obesity 87 (83,91) 71 (67,74)
Women Obesity 70 (65,75) 44 (41,47)
Women Extreme obesity 26 (21,31) 12 (10,14)
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Weight Gain at 10 Weeks With Antipsychotics
12 10 8 6 4 2 0 -2 -4 -6
6 5 4 3 2 1 0 -1 -2 -3
Weight Change (kg)
Weight Change (lbs)
Placebo
Molindone
Clozapine
Olanzapine
Thioridazine/
Haloperidol
Quetiapine
Mesoridazine
Ziprasidone
Fluphenazine
Risperidone
Sertindole
Chlorpromazine
At 6 Weeks Adapted from Allison DB et al. Am
J Psychiatry. 1999156(11)1686-1696
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Also cause weight gain

• Lithium
• Tricyclic antidepressants
• Selective serotonin reuptake inhibitors
• Valproic acid

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Context for Lifestyle Interventions in Serious
Mental Illness

• Cognitive impairment and persistent psychiatric
  symptoms
• frequent challenges in everyday functioning
• Disparities population socioeconomic and
  environmental risk factors for CVD
• unemployment
• low income
• social isolation
• Lifestyle interventions for this group need
  tailoring

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Objective and Setting

• Objective Determine the effectiveness of an
• 18-month tailored behavioral weight
• loss intervention in adults with serious
• mental illness
• Setting Psychiatric Rehabilitation Facilities

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Psychiatric Rehabilitation Facilities

• Outpatient day programs providing classes in
  rehabilitation environment
• Attendees generally on-site 2 days per week
• Opportunities for lifestyle interventions
• Frequent contacts
• Physical activity classes
• Meals served on-site

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ACHIEVE Trial Design

Measured weights and other outcomes
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ACHIEVE Trial Design

Measured weights and other outcomes
Program-wide recommendations for healthy menus
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Participants

• Overweight or obese attendees at one of 10
  Maryland psychiatric rehabilitation programs
• 18 years or older
• Major exclusion criteria
• Medical contraindication to weight loss
• CVD event in previous 6 months
• Inability to walk
• Active alcohol or substance-use disorder

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ACHIEVE Study Sites
Family Services Agency, Way Station, Prologue,
Inc., Mosaic Community Services, Keypoint Health
Services, Arundel Lodge, People Encouraging People
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Types and Number of Intervention Contacts
6 months 7-18 months
Group weight management Weekly Monthly
Individual weight management Monthly (alternating with group) Monthly (alternating with group)
Group physical activity 3 times per week all lead by intervention staff 3 times per week 1 then 2/week by rehab staff with video
Weigh-in Every week Every 2 weeks
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Characteristics (n291)
Age -yr 4511
Women () 50
White () 56
African-American () 38
Weight -kg 10321
Body Mass Index kg/m2 367
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Characteristics (n291)
Schizophrenia/schizoaffective disorder () 58
Bipolar disorder () 22
Substance abuse history () 52
Number of psychotropic medications 3.11.5
Atypical antipsychotic () 83
Never married () 74
Unable to work () 79
Lives in residential program or with care provider () 55
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Follow-up Weights

• Measured weight
• 99 of participants at 6 months
• 95 of participants at 12 months
• 96 of participants at 18 months

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Mean Weight Change (kg) According to Study Group
-0.3
-0.5
-0.2
-1.5
Weight Change (kg)
-2.5
-3.2 p0.002
-1.8
-3.0
-3.4
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Weight-Loss Outcomes at 18 months
Control Intervention
At or lower than baseline weight 49 64
gt 5 weight loss 23 38
gt 10 weight loss 7 19
P lt0.05 (vs. control), P lt0.01 (vs. control)
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Offered and Attended Sessions for the
Intervention Group
Session Type First 6 Months First 6 Months
Offered Attended
Group weight management 16 10
Individual weight management 5 4
Group exercise 61 30

All sessions 82 46
Median
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Offered and Attended Sessions for the
Intervention Group
Session Type First 6 Months First 6 Months 7-18 Months 7-18 Months
Offered Attended Offered Attended
Group weight management 16 10 13 7
Individual weight management 5 4 12 4
Group exercise 61 30 141 24

All sessions 82 46 164 31
Median
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Mean Weight Change (kg) in Intervention
Group ACHIEVE
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Mean Weight Change (kg) According to Study
Group ACHIEVE and PREMIER
Elmer, et.al. Annals Intern Med 2006
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Mean Weight Change (kg) According to Study
Group ACHIEVE and PREMIER
ACHIEVE -3.2 p0.002
PREMIER -2.7 p0.001
Elmer, et.al. Annals Intern Med 2006
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Conclusions from Trial

• Despite myriad challenges, with a tailored
  lifestyle intervention, overweight and obese
  adults with serious mental illness can
• make lifestyle changes and
• achieve substantial weight loss
• Our findings support implementation of targeted
  behavioral weight loss interventions in this
  high-risk population.

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Sample Size and Power

• Minimum Detectable Difference 4.5 lbs
• (clinical relevance ? SBP 3 mmHg
• ? hypertension incidence 20)
• Alpha error 0.05, Beta error 0.20
• SD? 12

Grant Revised Actual
Enroll (total N) 320 288 291
Lost to follow-up 20 10 4
N with Outcome 256 256 279
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Design Considerations

• Individual vs. cluster randomization
• Randomization strata (site, sex)
• Environmental dietary intervention
• Psychotropic medications

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Analysis Plan

• Intention-to-treat
• Likelihood-based mixed effects model
• Expected weight as 8 cell-means (2 study-groups x
  4 study visits)
• Full-rank, unstructured variance-covariance
  matrix
• Model adjusted for study site and sex
• Sensitivity analyses on potential impacts of
  missing data

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Recruitment

• Partnership with each study site
• Face-to-face approach
• Challenge resource intensive
• Benefits
• Defined target population
• Research team on-site presence sets foundation
  for study success

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Data Collection- Logistics

• 10 sites, windows for follow-up
• Training in working with psychiatric
  rehabilitation population
• All measures administered in-person
• Research team on-site daily

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Data Collection- Logistics

• Space and time considerations
• Bicycle ergometry cottage
• Phlebotomy laundry room

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Retention

• Facilitators mental health program attendees
• Challenges
• transient population
• lack of consistent phones, housing

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Retention-Home Visits

• 6 months 12 visits
• 12 months 32 visits
• 18 months 49 visits

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Lifestyle-Based Weight Loss

• Evidenced based recommendations
• Tailored to this population and setting

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Types and Number of Intervention Contacts
Contact Type 6 Months 7-18 Months
Group Weight Management 3 times per month monthly
Individual Weight Management monthly monthly
Group Exercise 3 times per week 3 times per week
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Dietary Recommendations
PREMIER ACHIEVE
Individual target calorie goals  Drink Water, No Sugar Drinks
Individual target calorie goals  Choose Smart Snacks
Individual target calorie goals  Choose Smart Portions 
 Eat 9 Fruits and Vegetables/day Eat 5 Fruits and Vegetables/day 
 Calories from fat 25 Avoid Junk Food   
Calories from saturated fat 7  Avoid Junk Food   
 Reduce sodium intake to 100mmol Avoid Junk Food   
Eat 2-3 servings of dairy/day   
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Exercise Recommendations
PREMIER ACHIEVE
 180 min/week 180 min/week provided by study 
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Self-Monitoring Recommendations
PREMIER ACHIEVE
 Detailed food/exercise log Simplified food/exercise tracker
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Weight Management Groups

• Build participant confidence
• Motivational Interviewing
• Self monitoring/awareness
• Interactive
• Behavioral Rehearsal
• Environmental Prompts
• Repetition
• Material taught in small content units

44
Weight Management- Individual Sessions

• High attendance
• Weigh-Ins
• Motivational Interviewing
• Individual Problem Solving
• High impact behavior
• Consider both PRP and home environment

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Group Exercise

• Exercise goal
• Exercise on-site 3 times/ week
• Exercise on other days 30 minutes on your own
• Classes
• Low Impact Aerobic
• Moderate Intensity
• Progressive
• Tailored to Population

46
Group Exercise Individual

Challenges Strategies
Cognitive abilities of group Various forms of cueing, repetition
Poor motor coordination and various levels of physical abilities Simple movements, repetition, visual and auditory cueing
Misinterpretation of physical symptoms Discussion of physiological changes that occur during exercise
Shyness/Comfort level Repetition, create private space
Access to appropriate clothing and shoes Work with participant and program staff to identify available resources
Attendance Behavioral modification, work with program staff
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Group Exercise Environment

Challenges Strategies
Physical space Modify movements to accommodate space
Distractions Try to create a more private space
Psychiatric rehabilitation program member support Establish rapport, work with program staff to establish expectations
Competing psychiatric rehabilitation groups Program staff support
Transitioning to program-led Group Exercise Classes Program staff training
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Lifestyle Intervention Summary
Challenges Strategies
Clear Messaging Simple recommendations, repetition, role-playing and interaction
Engaging in Conversation Motivational Interviewing, open-ended questions, directive approach
Heterogeneity in activity level and physical abilities Simple/basic movements, offer a range of intensity options, repetition
Attendance Behavioral modification strategies, collaboration with psychiatric program staff
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Environmental Dietary Intervention

• Child and Adult Care Food Program guidelines
• Met with Kitchen Supervisor
• Focus on all meals/snacks served
• Focus on all vending (food and beverage)
• CALORIES, CALORIES, CALORIES

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Environmental Dietary Intervention Challenges

• Kitchen Supervisors
• Budget
• Purveyors
• Vending
• Local mini-markets/gas stations

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From Participants
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Community Organization Perspective

• Increasing importance of improving physical
  health of mental heath consumers served
• Barriers with accessing healthy foods and safe
  places to exercise
• Stigma, low self-efficacy

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ACHIEVE at Mosaic Community Services

• High quality randomized clinical trial in
  community settings
• Strengths
• Level of care and concern for mental health
  consumers
• Built collaborations with Mosaic staff at all
  levels
• Took advantage of the existing environment
• Commercial kitchens
• Using space for exercise classes
• Challenges
• Programming scheduling in limited hours
• Staff turnover

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Challenges of Preventive Health Intervention
Implementation in Mental Health Settings

• Mental health settings traditionally not set up
  to deliver preventive/other somatic services
• Intensity of intervention needed for continued
  behavior change/health outcomes not just
  wellness
• Competing demands (e.g., staff time)
• Training and Supervision
• Payment

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Preventive Health and Somatic Services
Programming at Mosaic Community Services

• IDEAL Trial (NHLBI) comprehensive cardiovascular
  risk reduction intervention with health coaches
  hired by Mosaic, jointly supervised by Johns
  Hopkins
• Health Home program
• Co-location of somatic medical services from
  Federally Qualified Health Center at Mosaic site

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Summary

• Persons with serious mental illness are a
  vulnerable population with increased mortality
  and increased burden of a broad range of medical
  conditions.
• This population needs targeted and tailored
  interventions to improve their physical health.
• ACHIEVE was successful, but future implementation
  and dissemination important.
• There is much more work to be done to decrease
  health disparities in this population.

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Acknowledgements

• Participants
• Staff and leadership of
• Arundel Lodge, Inc.
• Family Services, Inc.
• Keypoint Health Services, Inc.
• Mosaic Community Services, Inc.
• Prologue, Inc.
• People Encouraging People, Inc.
• Way Station, Inc.
• Investigative team
• Present today Catherine Wren, Katie Rankin,
  Louis Sullivan, Courtney Cook, Traci Lambert
• National Institute of Mental Health
• NCRR U54 RR023561 / NCATS UL1 TR000424

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Thank you!
Contact gdaumit_at_jhmi.edu
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Characteristics (n291)
Total Intervention (n144) Control (n147)
Age-yr 4511 4712 4411
Women () 50 49 51
White () 56 57 55
Black () 38 36 40
Weight -kg 10321 10122 10421
Body Mass Index kg/m2 367 367 377
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Characteristics (n291)
Total Intervention (n144) Control (n147)
Schizophrenia/schizoaffective disorder 58 59 57
Bipolar disorder 22 19 25
Substance abuse history 52 53 50
Number of psychotropic medications 3.11.5 2.8 1.3 3.31.6
Atypical antipsychotic 83 83 83
Never married 74 72 76
Unable to work 79 78 80
Lives in residential program or with care provider 55 50 59
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Model-based estimates of between-group mean
differences and 95 confidence intervals in
cardiovascular risk factors and other
adiposity-related outcomes at 6 and 18 months
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Model-based estimates of between-group mean
differences and 95 confidence intervals in
cardiovascular risk factors and other
adiposity-related outcomes at 6 and 18 months
63
Program-wide Menu Recommendations

• -Assessing meals offered at sites
• -Offering advice to sites to modify meals to make
  them more healthy
• -initial consultation and then quarterly
  follow-up
• -Heterogeneity in what was offered
• -Organizational change

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Elevated CVD Risk Factors at Baseline in
Antipsychotic Trial
CATIE Study (n689) () NHANES (n687) ()
Smoking 68 35
Diabetes mellitus 13 3
Hypertension 27 17
CATIE Study Clinical Trials of Antipsychotic
Treatment Effectiveness Goff, et.al., 2005.
65
Casagrande, et.al. Community Mental Health
Journal, 2011
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Next steps

• How can evidence-based interventions like ACHIEVE
  be implemented and disseminated?
• What would delivery models look like?
• Future training of mental health staff to deliver
  weight loss coaching?

67
Comprehensive CVD Risk Reduction Trial in
Persons with Serious Mental Illness IDEAL Trial

• Objective Test the effectiveness of the IDEAL
  intervention compared to control in reducing
  overall CVD risk using the Framingham score
• Methods/Population Randomized clinical trial,
  Mosaic Community services, 250 participants
• Intervention Active arm - 18 months- Heart
  health coach provides individual behavioral risk
  reduction counseling, collaborates with mental
  health staff and social supports Nurse works to
  optimize treatment for hypertension,
  dyslipidemia, diabetes mellitus and smoking
  cessation including coordination with primary
  care provider and psychiatrist
• All participants healthy menus and group
  exercise offered
• Outcomes 1 CVD risk (Global Framingham Risk
  Score) 2weight, fitness, smoking, waist
  circumference, lipids, glucose, quality of life,
  psychiatric symptoms
• NHBLI R01-112299

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For More Information
gdaumit_at_jhmi.edu
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Implementation Issues

• Sustainment
• This type of behavioral intervention is time and
  effort intensive
• Contact time
• Fidelity
• Different delivery models?
• Mental health staff deliver all?
• Larger organizations contract out services?

70
Sustainment

• What happened after the study ended? Did sites
  continue physical activity classes and menu
  changes?
• K-24 Sustainability of physical health
  intervention in mental health settings
• Describe and evaluate sustainment and factors
  associated with enhancing or hindering
  sustainment of the healthy lifestyles
  intervention in the ACHIEVE Trial

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Opportunities

• Widespread interest from mental health consumers,
  family members, mental health programs - demand
  for services
• Demand for training from mental health programs
• Interest from Maryland Department of Health and
  Mental Hygiene

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Persons with SMI as a Health Disparities
Population
Adapted from Williams and Schulz
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Healthy Menu Changes

• New Breakfast
• Raisin bran cereal 1.5 cup
• 1 slice wheat bread with margarine
• 1 hard boiled egg
• 2 milk
• Orange juice
• Calories 870
• Fat calories 200
• Fiber 12.6 grams
• Protein 34 grams

• Old Breakfast
• Cheerios 1.5 cup
• 2 slices white bread with butter and jelly
• ¼ cup sugar
• Banana
• 2 milk
• Orange juice
• Calories 1150
• Fat calories 200
• Fiber 9.9 grams
• Protein 28 grams

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Common Background

• Intervention for healthy menus (like ACHIEVE)
• Group exercise classes offered across sites
• Dedicated staff person to coordinate exercise
  classes

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Active Intervention

• Heart health interventionist provides
• Individual counseling on CVD risk factors (e.g.,
  smoking) regular visits set up
• Coordination with primary care physician around
  heart health goals
• Includes accompanying on PCP visits, working on
  targets for blood pressure, diabetes, lipid
  control, med adherence
• Collaboration with other Mosaic staff and social
  supports around these goals
• Attend exercise class
• Participate in regular meetings
• Heart Health interventionist is a Mosaic employee

77
Serious Mental Illness (SMI)

• Schizophrenia, bipolar disorder or disabling
  depression
• 5.4 of U.S. adults, 1.1 schizophrenia, 2
  bipolar
• Generally require continuous, long term
  psychotropic medications
• Medicaid, Medicare, public assistance recipients,
  high health care utilization
• Comorbid substance use 50

78
Premature Mortality in Serious Mental Illness

• Contributors

• Calls to Action

• Cardiovascular disease risk factors
• Health risk behaviors obesity, physical
  inactivity, tobacco smoking
• Health risk factors diabetes and glucose
  control, hypertension, hyperlipidemia
• Cancer, Chronic Lung Disease, Liver Disease, HIV
• Health care quality

• SAMHSA 10x10 Wellness Campaign
• National Alliance on Mental Illness
• NIMH Strategic Plan
• Institute of Medicine Top 100 Topics for
  Comparative Effectiveness Research