Appendix D - Healthy Lifestyle Behaviors Program Manual

142 Pages·2008·1.39 MB·English

APPENDIX D

HEALTHY LIFESTYLE BEHAVIORS PROGRAM MANUAL

Reducing Medical Risks in Individuals
with Bipolar Disorder

Principal Investigator:
David J. Kupfer, MD

Prepared by:
Anne Germain, PhD, Marsha D. Marcus, PhD,
and Martica Hall, PhD

February 2008

A substantial portion of the material in this manual was drawn and adapted from
the Obesity and Nutrition Research Center (ORNC) Manual (Copyright 2003 © by
the University of Pittsburgh), developed by Bonnie Gillis, MS, RD for the ONRC,
supported by the National Institutes of Diabetes and Digestive and Kidney
Diseases, National Institute of Health

Reducing Medical Risks in Individuals with Bipolar Disorder
Appendix D: Healthy Lifestyle Behaviors Program Manual
HEALTHY LIFESTYLE BEHAVIORS
PROGRAM MANUAL
– TABLE OF CONTENTS –
Page
Introduction.......................................................................................................................................1
Documentation Used in This Study.........................................................................................1
Overall Treatment Strategy.....................................................................................................1
Healthy Lifestyle Behaviors Program – Overview...................................................................2
Bipolar Disorder Education.............................................................................................................6
Session 1: Pursuing Health Balance ....................................................................................6
Session 2: Education About Bipolar Disorder......................................................................11
Session 3: Understanding and Monitoring Tobacco, Alcohol, and Drug Use......................23
Healthy Sleep/Wake and Social Rhythm Practices.....................................................................28
Session 4: Social Rhythms..................................................................................................28
Session 5: Sleep Rhythms...................................................................................................34
Session 6: Physical Activity and Social and Sleep Rhythms...............................................41
Session 7: Relapse Prevention in Social and Sleep Rhythms.............................................46
Weight Loss....................................................................................................................................51
Session 8: Nutrition and Weight Loss..................................................................................51
Session 9: Using the Cues...................................................................................................70
Session 10: Healthy Food Choices When Eating Out.........................................................77
Session 11: Healthy Meal Plan............................................................................................82
Physical Activity.............................................................................................................................98
Session 12: Physical Activity for Weight Loss.....................................................................98
Session 13: Types of Fitness.............................................................................................108
Session 14: Putting It All Together.....................................................................................114
Session 15: Relapse Prevention........................................................................................116
Smoking Cessation (Optional)....................................................................................................121
Session 16: Understanding Smoking and Preparing to Quit..............................................121
Session 17: Stimulus Control and Quitting Plan................................................................130
Maintenance and Booster Sessions...........................................................................................138
Sessions 18 to 22: Monthly Maintenance and Booster Sessions .....................................139
Sessions 23 to 27: Quarterly Maintenance and Booster Sessions....................................140
Reducing Medical Risks in Individuals with Bipolar Disorder
Appendix D: Healthy Lifestyle Behaviors Program Manual
INTRODUCTION
The primary aim of this project is to understand whether it is possible to reduce medical risk factors in
adults with bipolar disorder and, in doing so, to improve psychiatric and functional outcomes. We seek to
examine the role of behavioral risk factors and presumed behavioral mediators and moderators of health
risk, including an initial test of an innovative behavioral intervention that targets modifiable medical risk
factors, in individuals suffering from bipolar disorder. We hope to identify such risk and protective factors,
intervene to reduce medical risk factors with the expectation that psychiatric outcomes will be
substantially improved, and thus provide a framework for further efforts at secondary prevention.
Working from a longitudinal treatment platform that integrates a multi-pronged health risk reduction
intervention with optimal psychiatric management, our health risk reduction approach will be aimed at
ameliorating sleep/wake disturbance, improving nutrition and dietary habits, and achieving modest
weight reduction by increasing physical activity, while at the same time providing optimal psychiatric
care. In order to examine another set of possible pathways (i.e., that it is the amelioration of psychiatric
symptoms that leads to improvements in physical health), we will contrast outcomes of subjects
receiving the integrated risk reduction intervention with those of subjects receiving psychiatric care with
medical monitoring that includes current evidence-based guidelines for the pharmacologic and
psychiatric management of bipolar disorder. We will achieve these aims using a 24-month randomized
intervention platform for the prospective study of 144 adult patients with bipolar disorder.
Documentation Used in This Study
This study uses five manuals created to guide the operations of the protocol and the treatment of the
patients. All study staff are required to read and become familiar with the contents of all three
manuals, regardless of their role on the project. These manuals will be used to train personnel
participating in the project and to ensure that all procedures are being followed consistently
throughout the study.
• The Study Procedures Manual contains descriptions of such administrative procedures as
role played by different staff members, training procedures, and data management
procedures. It describes procedures for patient intake, screening, evaluation, and termination.
• The Psychopharmacologic Treatment Manual describes the psychiatric care provided to
patients in both conditions and the algorithms for medication management.
• The Medical Monitoring Manual describes the guidelines to be followed for referring patients
to their primary care provider for medical care.
• The Healthy Lifestyle Behaviors Manual details the procedures to be followed for patients
assigned to the integrated risk reduction intervention condition including detailed guidelines for
each session of the health and well-being program, complete with worksheets and patient
homework assignments.
• The Assessment Manual includes descriptions and copies of all the data collection
instruments used in the study across all patients.
Overall Treatment Strategy
All subjects will receive guideline psychopharmacological intervention and psychiatric management
delivered by a psychiatrist. This will consist of optimal care for their bipolar disorder focusing on
symptom relief, management of side effects, and restoration of functioning. In the integrated risk
reduction intervention condition, the treating psychiatrist will work in collaboration with a certified
registered nurse practitioner (CRNP) and a health psychologist. The CRNP will be responsible for
coordinating the psychopharmacological care provided by the psychiatrist, the healthy lifestyle
behaviors program that will be delivered by the health psychologist, and the medical care provided by
the patient’s primary care physician (PCP). In the psychiatric care with medical monitoring
condition, the treating psychiatrist will be assisted by a psychiatric nurse clinician who will assess the
patient’s medical needs and refer the patient to their PCP for care.
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Healthy Lifestyle Behaviors Program – Overview
The goal of the healthy lifestyle behaviors program is to educate patients and teach them skills to
achieve a balanced lifestyle aimed at minimizing risk for medical morbidity and maximizing likelihood
of optimal mental and physical health. The overall rationale for the healthy lifestyle program is that
more regular and stable sleep/wake and social rhythms and modest weight loss achieved by
improving eating habits and by increasing physical activity can attenuate health risks and improve
mood symptoms and functioning. As such, the program is a comprehensive, integrative approach that
targets health risks on a daily basis across the 24-hour sleep/wake period.
A key component of IRRI is intervention by a health psychologist who aids patients in the
development and maintenance of an individualized lifestyle plan, teaches evidence-based strategies
for health-related behavior change, and provides support and encouragement for the patient’s goals.
All patients assigned to the IRRI condition will take part in a healthy lifestyle behaviors program
designed to: 1) minimize medical risks and promote quality of life through psychoeducation and
careful adherence to prescribed treatment; 2) improve sleep and social rhythm regularity; 3) promote
weight loss by: a) improving healthy eating habits or, where indicated, preventing weight gain; and
b) by increasing physical activity; and 4) promote smoking cessation. Because alcohol and drug use
adversely affects sleep and social rhythms, eating habits, and physical activity, the healthy lifestyle
program includes psychoeducation about substance use in the relevant modules. When indicated by
information collected through the Addiction Severity Index now included in this revised application,
participants will also receive information on potential treatment options and resources for addressing
substance use and will be encouraged to talk to their PCP about these options. The individualized
lifestyle plan will be reviewed by the CRNP for consistency with the patient’s medical status to ensure
that there are no contraindications to beginning weight loss and exercise programs.
The program incorporates psychoeducational material for each component and evidence-based
behavior change strategies that will be tailored for individual patients. The program is particularly
focused on the needs of individuals with bipolar disorder and incorporates principles of social rhythm
stabilization (Frank, 2005; Frank et al., 2005; Miklowitz et al., 2007). Throughout the intervention, the
health psychologist will use the Social Rhythm Metric-5 (SRM-5; Frank, 2005) version as one tool to
aid in accomplishing these objectives.
Based on our experiences and patient feedback in the IRRI pilot study, the health psychologist will
meet with the patient for 15 weekly, individual, 1-hr sessions in the first four months of treatment,
followed by 2 optional weekly sessions for smoking cessation, then 5 monthly sessions, and then 5
quarterly booster sessions until the end of the 24-month intervention, for a total of 25-27 sessions
(see Table 1). The weekly sessions will address the following major topic areas:
1) Bipolar Disorder Psychoeducation. This three-session initial educational component is based
on our clinical management paradigm (Frank et al., 2000) for the treatment of bipolar disorder. This
structured approach includes education about symptoms, medications, side effects, and relapse
planning. It has been associated with high rates of treatment adherence and improved clinical
outcomes. The following elements are introduced: education about bipolar disorder, basic healthy
sleep and social rhythm practices, and weight loss and management through nutrition and physical
activity. The rationale for targeting these domains and their specific roles in acquiring and maintaining
a healthy lifestyle is also presented and discussed. One session is dedicated to psychoeducation on
the prevalence and effects of tobacco, alcohol, and drug use on health in patients with bipolar
disorder.
2) Healthy Sleep/Wake and Social Rhythm Practices. Based on findings linking social rhythm
disruption to the onset of manic (and to a lesser extent depressive) episodes among patients with
bipolar disorder (Ashman et al., 1999; Malkoff-Schwartz et al., 2000), we will include a four-session
educational component and monitoring of basic sleep/wake and social rhythms (Frank, 2005; Frank
et al., 2005). Patients are educated regarding the link between circadian dysregulation and mood
episodes, are taught to identify the relationship between disruptions in routines and the onset and
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maintenance of mood symptoms, and are shown how to establish and monitor regularity of their daily
routines. Emphasis is placed on motivating patients to increase the regularity of daily routines to
maintain a regular bedtime and rise time. Specific recommendations for sleep and rise times to
regularize sleep patterns are also offered. The SRM-5 and actigraphy are used as feedback
mechanisms to monitor changes in both sleep/wake and social rhythms. Participants are also
introduced to the role of eating habits and physical activity as important zeitgebers for the circadian
system and to promote regular and consolidated sleep/wake and social rhythms. In this module, the
effects of nicotine, alcohol, and drugs on sleep and social rhythms are also discussed.
3) Weight Loss. Patients with bipolar disorder are at risk for weight gain, hyperglycemia, and
diabetes and consequently, sound nutrition and weight management skills are critical. This
component consists of a nutrition module and a physical activity module. Alcohol use in relation to
weight loss, nutrition, and exercise are also addressed in this module.
a) Nutrition: This four-session module builds on previously introduced concepts of regular
sleep/wake and social rhythms by stressing the importance of regular meals and adequate nutrition.
The Dietary Guidelines for Americans 2005 (U.S. Department of Health and Human Services & U.S.
Department of Agriculture, 2005) serve as the foundation for the intervention. Components include
education on nutrition guidelines, making sensible food choices, and information regarding nutrients,
fats, sugars, and cholesterol. One goal of this module is to promote healthy food choices in a stepwise
fashion. Additionally, we target a modest weight loss of 5% to 7% during the course of the
intervention. The recommended rate of weight loss is 1 to 2 lbs per week (i.e., decreasing calories by
500 to 1000 per day). These goals are consistent with those of the successful lifestyle intervention
utilized in the Diabetes Prevention Program (Diabetes Prevention Program Research Group, 2002a,
2002b). Such an approach has been shown to be effective in patients with severe mental illnesses
including bipolar disorder (Alvarez-Jimenez et al., 2006; Mauri et al., 2006). We help each participant
to develop an eating plan consistent with individual and cultural preferences and designed to achieve
and maintain a healthy body weight (BMI <25). A daily food diary and the Fat & Fiber Behavior
Questionnaire (FFB, Kristal et al., 1990) is used to help patients and staff to monitor progress and
difficulties in adhering to healthy eating habits and food choices. The Fat & Fiber Behavioral
Questionnaire will be completed at baseline and every 3 months thereafter.
b) Physical Activity: Physical activity is also an important component of regular sleep/wake
and social rhythms and a critical component of weight loss and management. This four-session
module focuses on education about the importance of physical activity to increase energy expenditure
and to promote weight loss and safely incorporating regular physical activity into their routines.
Materials from the National Center for Chronic Disease Prevention and Health Promotion (2003)
provide the foundation for the module. Elements include the development of a program for regular
activity, weekly goals for energy expenditure, and the gradual increase of physical activity over time.
We prescribe stepwise goals to achieve moderate levels of physical activity, in particular, brisk
walking for 30 to 45 minutes 3 to 5 days per week. The Paffenbarger Activity Questionnaire will be
completed by the patient at entry to the study and every 3 months thereafter to help monitor progress
and difficulties in adhering to physical activity goals.
4) Smoking Cessation. The optional two-session smoking cessation module employs a cognitive-
behavioral approach based on the American Cancer Society’s FreshStart Program (Shiffman & Cline,
1990). The FreshStart Program has been shown to obtain a 22% quit rate (Lando et al., 1990) and
includes psychoeducation about nicotine addiction, cessation planning, coping skills for managing
smoking urges, and relapse prevention. Additional attention is given to potential interactions between
nicotine use and medications used to treat bipolar disorder.
These target areas (bipolar disorder psychoeducation, psychoeducation on nicotine, alcohol, and drug
use, healthy sleep/wake and social rhythm practices, weight loss, and smoking) are integrated under
the umbrella of the social rhythms framework which explicitly involves emphasis on the
interdependence of these areas to achieve healthy life balance. Each session includes a review of
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Appendix D: Healthy Lifestyle Behaviors Program Manual
information collected since the previous visit on the self-monitoring log for targets being addressed at
different times throughout the intervention. For example, Sessions 4 to 7 focus on developing,
implementing, and achieving regular sleep/wake and social rhythms in a stepwise manner, but also
includes the introduction and review of information collected on the self-monitoring log regarding
physical activity and food intake. The focus of the review portion of the intervention session is shifted
to nutrition and weight loss during Sessions 8 to 11, but also includes a review of sleep/wake and
social rhythms and physical activity. A similar strategy is adopted for Sessions 12 to 15 on physical
activity and Sessions 16 and 17 (optional) on smoking cessation. All modules include a review
component aimed at identifying signs of deviations and relapses from healthy practices as well as
strategies to correct these.
Table 1: Components of the Healthy Lifestyle Behaviors Program
Component Topics Addressed Therapeutic Goals
1) Bipolar Disorder • Overview and rationale of integrated risk reduction • Increase understanding of the
Psychoeducation intervention importance of a balanced
• Education about bipolar disorder lifestyle and ways to achieve it
(3 sessions) • Importance of a balanced lifestyle • Identify important activities to
• Prevalence and impacts of common health risk behaviors enhance sleep/wake and social
in bipolar patients: nicotine, alcohol, and drug use rhythms
• Enhance adherence to self-
monitoring of sleep/wake and
social rhythms and exercise
2) Healthy Sleep/ • Education on sleep/wake disturbances & mood disorders • Continue self-monitoring of
Wake and Social • Relationship between disruptions in sleep/wake and social exercise and sleep/wake and
Rhythm Practices rhythms and onset and maintenance of mood symptoms social rhythms
• Education on healthy sleep/wake rhythms and habits • Identify, enhance, and
(4 sessions) • Education on healthy social rhythms and habits consolidate sleep/wake and
• Identifying, implementing, and consolidating sleep/wake social rhythms though the
and social rhythms implementation of regular
• Effects of nicotine, alcohol, and drugs on sleep and social sleep/wake and social rhythm
rhythmicity schedules in a gradual manner
• Eating habits and physical activity as important cues to • Initiate self-monitoring of food
enhance sleep/wake and social rhythms intake
• Relapse prevention for sleep/wake and social rhythms
3) Weight Loss • Education about healthy eating habits • Enhance/maintain adherence to
• How to make healthy food choices self-monitoring of food intake
a. Nutrition • How to lose weight • Reduce calorie intake by 500
• Ways to eat fewer calories and less fat calories per day in a progressive
(4 sessions) • Exercise and weight loss manner
• Alcohol use in weight management • Achieve a modest weight loss
• Relapse prevention for healthy eating and weight loss (5% to 7% of initial weight)
b. Physical • Education about the importance of physical activity and • Identify and adhere to number of
Activity time management strategies to incorporate exercise in a minutes of exercise to achieve
weekly routine over the next 4 weeks
(4 sessions) • Education about moving more and exercising safely • Incorporate moderate-intensity
• Identifying ways to add interest and variety to physical exercise for 30 minutes 3 to 5
activity plan times per week in schedule
• How to stay motivated; relapse prevention
• Review the effects of smoking on health • Self-monitoring of smoking
4) Smoking • Education about the interactions between nicotine and behaviors and triggers
Cessation medications used to treat bipolar disorders • Identify benefits of quitting
• Education about stimulus control and smoking smoking
(2 optional • Identify relationship among smoking behaviors, sleep and • Plan smoking cessation: identify
sessions) social rhythms, and eating habits a quit day and conduct a quit
• Education about symptoms of recovery from smoking ceremony
• Education about available resources to support people • Identify and incorporate coping
who quit smoking skills to manage urges to smoke

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Appendix D: Healthy Lifestyle Behaviors Program Manual
The monthly (Sessions 18 through 22) and quarterly sessions (Sessions 23 through 27) are follow-up
sessions to: 1) assess patients’ mood, sleep/wake and social rhythms, nutrition, and exercise;
2) evaluate progress towards the achievement and maintenance of individual patients’ goals
regarding regular social and sleep rhythms, eating habits, weight management, and physical activity;
3) reinforce adherence and progress; 4) provide supportive directions to address difficulties and
relapses; and 5) problem-solve barriers the patient has toward achieving his/her goals. These
sessions allow for significant flexibility and provide an opportunity for the health psychologist and the
patient to focus on any of the lifestyle areas that they deem important.
Each one-hour session with the health psychologist includes the assessment of symptoms, a review
of homework, identification of barriers to implementation of earlier recommendations, and
troubleshooting to identify strategies to overcome or minimize barriers. Feedback on the regularity of
sleep/wake and social rhythms and previous assignments is also provided. The remainder of this
manual provides details on session content, sample scripts, handouts, and patient homework
assignments.

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Bipolar Disorder Education

Session 1:

Pursuing Health Balance

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Appendix D: Healthy Lifestyle Behaviors Program Manual
SESSION 1: PURSUING HEALTH BALANCE

1. The importance of regularity and balance. The coach should begin by explaining that the theme
of the healthy lifestyle behaviors program component of IRRI is regularity of rhythms including
sleep and social rhythms. Regular rhythms promote health, whereas unstable rhythms are risk
factors for poor health outcomes. Physical activity, nutrition, and weight loss management are
integral parts of healthy rhythms because they directly contribute to protect or interfere with
healthy rhythms. Explain that you will discuss the idea of regular rhythms as it applies to multiple
realms of the patient’s life. Regularity and balance are, therefore, a term that will be repeatedly
emphasized throughout the course of the intervention. The coach should explain the importance
of a regular, balanced lifestyle—that is, one characterized by a degree of regularity and balance in
daily activities to promote habits that improve one’s health and that reduce risk behaviors that may
negatively affect health. We focus on the theme of regularity and balance because research
supports the notion that leading an irregular and imbalanced lifestyle enhances the likelihood of
mood problems in individuals with bipolar disorder. Therefore, by maintaining regular sleep, social
and physical activity rhythms, and by increasing the sense of balance in life, periods of mood
stability may be prolonged.

2. Overview/rationale for the treatment. Outline the intervention with the patient, reviewing the four
elements of the healthy lifestyle behaviors program. Use the handout, “Components of a Balanced
Lifestyle” to highlight of close relationships between the target domains of the intervention. Review
the rationale for each element, stressing its role in maintaining mood stability in individuals with
bipolar disorder, as follows:
a. Education about bipolar disorder. Patients are best prepared to manage bipolar illness when
they have a thorough understanding of its causes, symptoms, and treatments.
b. Basic sleep and social rhythm hygiene. Individuals with bipolar disorder are highly sensitive to
changes in sleep-wake cycles (e.g., when they go to bed, fall asleep, and wake up), and even
minor changes can precipitate mood symptoms. Regular patterns of daily activity can also help
to maintain mood stability (e.g., when individuals go to work, eat dinner, etc.). Therefore, we
will talk about ways to keep daily routines stable, even when external events make this
challenging. Specific recommendations to promote a regular sleep-wake schedule, to
consolidate sleep-promoting habits, and to attenuate sleep-interfering habits are discussed
and individually tailored for each participant.
c. Weight loss: nutrition and physical activity. Patients with bipolar disorder are at risk for weight
gain, hyperglycemia, and diabetes for multiple reasons. Therefore, sound nutrition and weight
management skills are critical for individuals with bipolar disorder to maintain good health.
Self-monitoring of caloric intake and specific strategies to promote healthy eating habits and
modest weight loss are presented and implemented. Physical activity is also an important
component of weight loss. In addition to being mindful of caloric intake, energy expenditure (or
energy use) is necessary to lose and/or maintain a healthy weight. Physical activity is also an
important cue for social and sleep rhythms. Most of us know that exercise helps to maintain
optimal physical health; exercise also contributes to mental health by managing depression,
anxiety, and stress. We will thus work to create an exercise routine that is reasonable and
realistic.
d. Smoking, tobacco, alcohol, and drug use. Patients with bipolar disorder are 2 to 3 times more
likely to develop tobacco-related medical illnesses and 6 to 7 times more likely to develop
alcohol or drug abuse. Smoking, tobacco, alcohol, and drug use can directly influence
symptoms of bipolar disorder, sleep and social rhythms, healthy eating habits, and physical
activity. Throughout these modules, information regarding these behaviors will also be
discussed. The main goal is to provide education to better understand the complex
relationships between tobacco, alcohol, and drug use and symptoms of bipolar disorders,
sleep and social rhythms, healthy eating habits and exercise, and weight management.

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Appendix D: Healthy Lifestyle Behaviors Program Manual
3. Discuss the handout “A Balanced Lifestyle.” Have the patient go through his/her week and
identify the “shoulds” and the “wants.” Identify and discuss areas for improving balance in his/ her
life.

HOMEWORK
Encourage the patient to think about each of the four areas of his/her life discussed and
contemplate areas in which the patient feels he/she needs to work toward increased balance and
other areas in which he/she has managed to attain a comfortable balance.

HANDOUT
A Balanced Lifestyle

REFERENCES
None

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Appendix D: Healthy Lifestyle Behaviors Program Manual