a cognitive/behavioral group intervention for weight loss in patients treated with atypical...

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A cognitive/behavioral group intervention for weight loss in patients treated with atypical antipsychotics Mary Weber a, * , Kathleen Wyne b a School of Nursing, The University of Texas at Arlington, 411 S. Nedderman Dr. Box 19407 Arlington, TX 76019-0407, United States b Division of Endocrinology and Metabolism, Department of Internal Medicine, University of Texas Southwestern Medical Center at Dallas, United States Received 8 July 2005; received in revised form 9 January 2006; accepted 17 January 2006 Available online 28 February 2006 Abstract Obesity and diabetes have caused problems for individuals with schizophrenia long before atypical antipsychotic agents. The prevalence of obesity, insulin resistance, impaired glucose tolerance, type 2 diabetes mellitus, dyslipidemia, and the Metabolic Syndrome has increased in people with schizophrenia as compared to the general population. Risk reduction studies for persons with obesity, diabetes, and cardiovascular disease indicate that cognitive/behavioral interventions that promote motivation and provide strategies to overcome the barriers in adherence to diet and activity modification are effective interventions for weight management and risk reduction. In the landmark multi-center randomized-controlled trial study, the Diabetes Prevention Project (DPP), a cognitive/behavioral intervention, was more successful in producing weight loss and preventing diabetes than the drugs metformin, troglitazone or placebo. This pilot study examined the effectiveness of a cognitive/behavioral group intervention, modified after the DPP program, in individuals with schizophrenia or schizoaffective disorder taking atypical antipsychotics in a large urban public mental health system. Outcome measures included body weight, body mass index, waist–hip ratios, and fasting glucose levels. Both groups demonstrated elevated fasting glucose levels and were obese with a mean BMI of 33. The group that received the cognitive/behavioral group intervention lost more weight than the treatment as usual group. The CB group participants lost an average of 5.4lb or 2.9% of body weight, and those in the control group lost 1.3lb or 0.6% body weight. The range of weight loss for the treatment group was from 1 to 20lb. This pilot study has demonstrated that weight loss is possible with cognitive/behavioral interventions in a population with a psychotic disorder. D 2006 Elsevier B.V. All rights reserved. Keywords: Cognitive/behavioral intervention; Weight loss; Atypical antipsychotics; Schizophrenia 1. Introduction Weight gain is a serious health concern for individuals with schizophrenia. It increases their mor- 0920-9964/$ - see front matter D 2006 Elsevier B.V. All rights reserved. doi:10.1016/j.schres.2006.01.008 * Corresponding author. Tel.: +1 817 272 2776; fax: +1 817 272 5006. E-mail address: [email protected] (M. Weber). Schizophrenia Research 83 (2006) 95 – 101 www.elsevier.com/locate/schres

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www.elsevier.com/locate/schres

Schizophrenia Research

A cognitive/behavioral group intervention for weight loss in

patients treated with atypical antipsychotics

Mary Weber a,*, Kathleen Wyne b

a School of Nursing, The University of Texas at Arlington, 411 S. Nedderman Dr. Box 19407 Arlington, TX 76019-0407, United Statesb Division of Endocrinology and Metabolism, Department of Internal Medicine, University of Texas Southwestern Medical Center at Dallas,

United States

Received 8 July 2005; received in revised form 9 January 2006; accepted 17 January 2006

Available online 28 February 2006

Abstract

Obesity and diabetes have caused problems for individuals with schizophrenia long before atypical antipsychotic agents.

The prevalence of obesity, insulin resistance, impaired glucose tolerance, type 2 diabetes mellitus, dyslipidemia, and the

Metabolic Syndrome has increased in people with schizophrenia as compared to the general population. Risk reduction studies

for persons with obesity, diabetes, and cardiovascular disease indicate that cognitive/behavioral interventions that promote

motivation and provide strategies to overcome the barriers in adherence to diet and activity modification are effective

interventions for weight management and risk reduction. In the landmark multi-center randomized-controlled trial study, the

Diabetes Prevention Project (DPP), a cognitive/behavioral intervention, was more successful in producing weight loss and

preventing diabetes than the drugs metformin, troglitazone or placebo. This pilot study examined the effectiveness of a

cognitive/behavioral group intervention, modified after the DPP program, in individuals with schizophrenia or schizoaffective

disorder taking atypical antipsychotics in a large urban public mental health system. Outcome measures included body weight,

body mass index, waist–hip ratios, and fasting glucose levels. Both groups demonstrated elevated fasting glucose levels and

were obese with a mean BMI of 33. The group that received the cognitive/behavioral group intervention lost more weight than

the treatment as usual group. The CB group participants lost an average of 5.4lb or 2.9% of body weight, and those in the

control group lost 1.3lb or 0.6% body weight. The range of weight loss for the treatment group was from 1 to 20lb. This pilot

study has demonstrated that weight loss is possible with cognitive/behavioral interventions in a population with a psychotic

disorder.

D 2006 Elsevier B.V. All rights reserved.

Keywords: Cognitive/behavioral intervention; Weight loss; Atypical antipsychotics; Schizophrenia

0920-9964/$ - see front matter D 2006 Elsevier B.V. All rights reserved.

doi:10.1016/j.schres.2006.01.008

* Corresponding author. Tel.: +1 817 272 2776; fax: +1 817 272

5006.

E-mail address: [email protected] (M. Weber).

1. Introduction

Weight gain is a serious health concern for

individuals with schizophrenia. It increases their mor-

83 (2006) 95–101

M. Weber, K. Wyne / Schizophrenia Research 83 (2006) 95–10196

bidity and serves as an additional reason for non-

adherence with pharmacologic treatment (Green et al.,

2000; Perkins, 2002; Weiden et al., 1996). It is

estimated that 40% to 60% of persons with schizo-

phrenia are obese as compared to 20% prevalence in the

general US adult population (Green et al., 2000). Thus,

it is not surprising that the prevalence of insulin

resistance, impaired glucose tolerance, type 2 diabetes

mellitus, and the MS has increased in people with

schizophrenia as compared to the general population

(Henderson et al., 2000). The recent introduction of

new pharmacologic therapies for the treatment of

schizophrenia, which are commonly referred to as the

datypical antipsychoticsT has been correlated with a

further increase in the prevalence of excess body

weight and type 2 diabetes in this population (Allison

and Casey, 2001; Allison et al., 1999). In one of the few

descriptive studies examining the health of those with

schizophrenia, Brown and colleagues reported in

1999 that on average, individuals with schizophrenia

eat a diet high in fat, smoke heavily, and get very little

exercise. In addition to obesity, individuals with

schizophrenia appear to have increased visceral fat,

regardless of drug treatment, which is highly correlated

with insulin resistance and risk of diabetes (Thakore

et al., 2002).

In a recent epidemiological study, as little as a 5%

increase in body weight is correlated with a 200%

greater risk of developing this metabolic or insulin

resistance syndrome by middle age (Everson et al.,

1998). Thus, individuals with schizophrenia, already

overweight, significantly increase their chances of

significant co-morbidity with as little as a 5% weight

gain. Data to support prevention of weight gain and

appropriate choices of antipsychotic medications has

become a public health priority. Risk reduction

studies for persons with obesity, diabetes, and

cardiovascular disease indicate that cognitive/behav-

ioral interventions that promote motivation and

provide strategies to overcome the barriers in

adherence to diet and activity modification are

effective interventions for weight management and

risk reduction (Nawaz and Katz, 2001; Williamson

and Perrin, 1996).

In the landmark multi-center Diabetes Prevention

Project (DPP), a cognitive/behavioral lifestyle inter-

vention was more successful in producing weight loss

and preventing diabetes than the drug metformin

(Knowler et al., 2002). The group that received

troglitazone actually had the lowest diabetes incidence

in the first year but they only received the drug for the

first 9 months and this benefit was not sustained over

the three years of the trial (Knowler et al., 2005). The

intensive lifestyle intervention in the DPP was found

to decrease the incidence of diabetes by 58% in high-

risk populations. Further, the investigators found that

the randomized clinical data collected from 27 clinical

sites throughout the country, showed that intensive

cognitive/behavioral therapies that focused on modi-

fying diet and increasing activity were just as effective

for both men and women, in all age groups, and in all

ethnic groups.

Weight reduction studies in the population with

schizophrenia have been cited in the literature but

results are mixed and none have used a randomized-

control model. This pilot study examined the effective-

ness of a randomized-control group design cognitive/

behavioral group intervention based on the DPP

lifestyle intervention in those individuals who were

taking atypical antipsychotics for schizophrenia or

schizoaffective disorder in a large urban public mental

health clinic system. It was hypothesized that those

individuals completing the 16-week program would

demonstrate significantly different weight, body mass

index (BMI), waist–hip ratio (WHR), and fasting

glucose levels than those in the treatment as usual

(TAU) group.

2. Methods

2.1. Sample

A randomized, placebo-controlled design was

chosen for this pilot study to test the efficacy of this

group intervention. The sample was recruited over

approximately one month from over 900 patients per

month attending a large urban public mental health

clinic in Dallas. The PI used flyers in the clinic as

well as working with the case managers and medical

providers to recruit over 30 potential subjects. The

first seventeen subjects who qualified and were

interested in participating were randomized to the

16-week cognitive/behavioral (CB) group interven-

tion or treatment as usual (TAU) care. The inclusion

criteria included subjects diagnosed by the Diagnostic

M. Weber, K. Wyne / Schizophrenia Research 83 (2006) 95–101 97

Statistical Manual 4-TR (DSM) criteria for schizo-

phrenia or schizoaffective disorder, taking only one

oral atypical antipsychotic, between the ages of 18

and 65 years old, and have a BMI equal to or greater

than 25. Patients were excluded if they were acutely

psychotic, in need of immediate detoxification, or

alcohol dependent. The study consisted of 17 patients,

12 females and 5 males. There were 9 Afro-American

subjects, 3 Hispanic (English speaking), and 5 Cau-

casian subjects. Subjects in both groups were similar

in terms of weight, BMI, WHR, drug, gender, and

ethnicity (see Table 1). It is important to note that

both groups showed impaired glucose tolerance at

baseline. During the study, two subjects in the TAU

group were dropped because of worsening psychosis

and re-hospitalization. One member of the treatment

group relapsed but completed the study. There were

no subjects dropped in the CB group. All members of

the treatment group completed the study. Multiple

retention strategies found to be successful in the past

were employed in this study. Calendars were provid-

ed to each subject in both groups to assist them in

remembering the appointments. In addition, all

subjects were called by a non-blind rater the night

before appointments. Additionally, subjects were

given $5.00 for each completed visit to assist them

with transportation to the clinic and as compensation

for their time. This study was approved by the

Institutional Review Board at the University of

Texas at Arlington. All subjects were interviewed

and after the risks and benefits of the study were

Table 1

Pre-intervention comparisons

Variables

BMI (kg/m2)

Weight (lb)

WHR

Fasting glucose (mg/dL)

Gender Female

Male

Race/ethnicity African American

Caucasian

Hispanic

WHR = waist–hip ratio.

BMI = body mass index.

explained, verbal and written informed consent

was obtained.

2.2. Outcome measures

All measurements were completed by one Gradu-

ate Research Assistant (GRA) who was blind to the

randomization. Weight, BMI, WHR and blood sugar

were measured pre- and post-intervention. At pre-

intervention, and every 4 weeks, each subject from

both the treatment and TAU group were weighed and

measured by the blinded GRA. Finger-stick blood

glucose levels where done on each subject at the

beginning and the end of the study using the same

glucometer, Ascensia DEX 2. Weight, BMI, and

WHR were measured every 4 weeks on each subject.

The same scale and height measurement tool were

used throughout the study. The waist–hip ratio (WHR)

was measured in inches using a standard tape measure

at the umbilicus and at the widest point of the hips.

Fasting blood glucose was measured via a finger stick

with the squeezing of a drop of blood onto a reagent

strip which was read by a digital readout. The

Ascensia DEX 2, a plasma referenced glucose meter,

was used in this study. Accuracy and precision

information was obtained from the manufacturer of

the glucometer (Bayer Healthcare, 2005). Accuracy of

the glucometer has been shown by comparing

capillary specimens read by the glucometer and then

compared to read outs from three automated chemis-

try analyzers. Correlational analysis of the plasma and

Pre-intervention means

(ranges)

Cognitive/behavioral

treatment (CB)

Treatment as usual (TAU)

33 (25–43.8) 33 (28.2–37)

191 (157–280) 200.8 (166–238)

0.88 0.90

102 (63–221) 122 (76–269)

5 (62.5%) 7 (77.8%)

3 (37.5%) 2 (22.2%)

5 (62.5%) 4 (44.4%)

2 (25.0%) 3 (33.3%)

1 (12.5%) 2 (22.2%)

M. Weber, K. Wyne / Schizophrenia Research 83 (2006) 95–10198

Ascensia DEX 2 readings produced a correlation

coefficient of r =0.98. Precision of the Ascensia DEX

2 was determined by testing whole blood pools

supplemented with glucose to obtain five glucose

levels. Precision results using test solutions ranged

from a standard deviation at 2.7 to 5.7 with a

confidence value (CV) of 1.5% to 3.5%. According

to the American Diabetic Association (ADA, 1996),

error of meters designed for self monitoring and point

of care testing of glucose should not exceed 5%. After

reviewing these values, the Ascensia DEX 2 was

determined to be an accurate and precise measurement

of glucose for this study.

2.3. Treatment intervention

2.3.1. Cognitive/behavioral group intervention

The cognitive/behavioral intervention (CB) includ-

ed once a week 1-h group sessions for 16 weeks

(see Table 2). Content of the groups was based on

cognitive/behavioral strategies to promote risk reduc-

tion that were demonstrated successful in the Diabetes

Prevention Project (DPP). The sessions were held at

one of the public mental health clinics in Dallas

County. Sessions included role plays, goal setting,

motivational scaling, problem solving, risk vs. bene-

fits comparisons, discussions on barriers to change,

Table 2

Treatment received by each subject for the 16-week cognitive/

behavioral group intervention

Week of the study Cognitive/behavioral subjects

Week 1 Class 1: Getting started being

active and losing weight

Week 2 Class 2: Move those muscles

Week 3 Class 3: Being active: A way of life

Week 4 Class 4: Be a fat detective

Week 5 Class 5: Three ways to eat less fat

Week 6 Class 6: Healthy eating

Week 7 Class 7: Take charge of what’s around you

Week 8 Class 8: Tip the calorie balance

Week 9 Class 9: Problem solving

Week 10 Class 10: 4 keys to healthy eating out

Week 11 Class 11: Talk back to negative thoughts

Week 12 Class 12: The slippery slope of

lifestyle change

Week 13 Class 13: Jump start your activity plan

Week 14 Class 14: Make social cues work for you

Week 15 Class 15: You can manage stress

Week 16 Class 16: Ways to stay motivated

presentations on low-fat diets, and plans to increase

activities such as walking. Each person kept a food

and activity diary which was turned in at the

beginning of each session. A Psychiatric Nurse

Practitioner (PMHNP) provided the intervention.

The PMHNP was trained over 2 weeks and seen

weekly by the first author for content validity.

Sessions were monitored each week.

2.3.2. Treatment as usual (TAU)

Subjects in the TAU group continued to receive

care as usual at the clinic. They were weighed and

measured by the blind researcher at regular four week

intervals.

2.4. Data analysis

Since this was a pilot study, a power analysis was

not completed. Results from this study will be used to

identify sample size in future studies. The data were

analyzed for statistical significance using the paired

t-test. Individual member’s pre- and post-test scores

included weight, waist–hip circumferences, BMI, and

fasting glucose levels. All tests were two-tailed. The

criterion for statistical significance was .05.

3. Results

Demographic and clinical characteristics of the two

groups prior to intervention are summarized in Table 1.

Both groups tended to be obese with the mean BMI of

subjects in each treatment arm measuring 33. Five

subjects in each group were taking olanzapine with the

remaining subjects taking risperidone, ziprasidone, and

quetiapine. None of the subjects were taking clozapine.

There were no differences in weight, BMI, or blood

sugar between the subjects based on drug, although

both groups showed impaired glucose tolerance,

similar to the DPP population. It was interesting that

the majority of subjects were female and African

American, which is unlike most studies described in the

literature.

The group that received the cognitive/behavioral

group intervention lost more weight than the treatment

as usual group. The CB group participants lost an

average of 5.4lb or 2.9% of body weight, and those in

the control group lost 1.3 lb or 0.6% body weight. The

Table 3

Group differences

Group statistics

Group N Mean Std.

deviation

Std. error

mean

wdiff Placebo 7 1.3571 7.35393 2.77953

Treatment 8 5.4063 6.54236 2.31307

bmidiff Placebo 7 .2429 1.22455 .46284

Treatment 8 .9500 1.04608 .36985

whrdiff Placebo 7 � .0054 .03945 .01491

Treatment 8 .0148 .03956 .01399

wdiff = difference in weight.

bmidiff = difference in BMI.

M. Weber, K. Wyne / Schizophrenia Research 83 (2006) 95–101 99

range of weight loss for the treatment group was from 1

to 20lb. The change in mean BMI was 2.9% for the

treatment group and 0.8% for the control group. There

were no significant differences in weight, WHR, or

BMI scores pre- and post-test based on t-test results

(Table 3). Unfortunately, the FBS post measure could

not be analyzed because it would found later that 2 of

the subjects had eaten. Power analysis indicated that a

sample of 37 in each group would be needed to show

significance with a p b0.05. Unfortunately, obtaining a

sample of this size was not possible in this study. Thus,

a major limitation of this pilot study was the small

sample size.

What was a significant outcome of this study was

the 100% retention rate for the treatment group over the

16 week period. Fifteen participants (88%) completed

the program, losing 2 subjects from the TAU group to

relapse and re-hospitalization. Each subject in the CB

group was very interested in this group and highly

motivated to lose weight. This type of retention

suggests that weight gain is a significant problem in

this population and that these patients can succeed in a

CB program.

4. Discussion

No rigorous randomized-controlled trials of CB

interventions to combat weight gain in public mental

health settings have been reported. This study is the

first randomized trial that was conducted in the larger

community of patients with schizophrenia who are

experiencing significant weight gain problems with

atypical antipsychotics. Behavioral treatment of obe-

sity in patients with schizophrenia was reported as

early as 1963 with single case reports (Ayllon, 1963;

Bernard, 1968). Since that time, there have been

reports of weight loss in both inpatient and residential

settings using behavioral treatment strategies in

patients taking traditional antipsychotic medication

(Knox, 1980; Rotatori et al., 1980).

More recently several studies have reported some

weight loss after structured behavioral interventions.

Wirshing et al. described pilot data on weight

management from multiple antipsychotic drug

clinical trials and the use of a food diary and a

bwellnessQ clinic run by a Clinical Nurse Specialist

(Wirshing et al., 1999). When weight went up, more

intensive interventions were instituted. Umbricht

et al. (2001) in a letter to the editor, described the

weight reducing benefits among 6 patients of a

cognitive/behavioral model combining group and

individual sessions, but this program has not been

evaluated with a randomized clinical trial. In a quasi-

experimental study, Ball et al. (2001) investigated

the effectiveness of using the Weight Watchers

program for patients with schizophrenia on olanzapine.

Participants in the treatment group attended weekly

meetings along with exercise sessions, and tokens were

received to reinforce behavior. After ten weeks, 11

participants had a mean loss of 5lb which is similar to

this study. In a study by Aquila and Emanuel (2000), a

low-fat, low-calorie diet and weight reduction support

was provided to participants taking atypical antipsy-

chotics but there was no statistically significant change

in body weight after 12 months and 18 months.

Vreeland et al. (2001) found that a 12 week weight

control program involving 31 participants in a partial

hospitalization program was effective in producing

weight loss in these obese individuals taking atypical

antipsychotics. A statistically significant change was

seen in body weight and BMI.

Littrell et al. (2003) described a quasi-experimental

educational intervention that proved successful in

patients on olanzapine. The bSolution for WellnessQ isan educational intervention that uses some cognitive/

behavioral techniques. In Littrell’s study, the majority

of subjects were Caucasian men with a mean BMI

between 26 and 27, which is just in the overweight

range. In our study, the majority of subjects were

African American or Hispanic and female, with a

mean BMI of 33, well into the obesity range. Basson

et al. (2001) noted that African Americans gained

M. Weber, K. Wyne / Schizophrenia Research 83 (2006) 95–101100

more weight with the atypical antipsychotics, and we

found that many Caucasian men in our clinics did not

meet the inclusion criteria of a BMI of 25 or greater,

thus demonstrating the significant problem of weight

gain in the African American and Hispanic population

with schizophrenia in this large urban public mental

health system.

It was very interesting that both groups did not show

weight gain, which would be expected in this popula-

tion, especially with the trend in this population to

continue to gain weight each month. Perhaps even a

simple intervention of bweighing-inQ may prove to

have some benefit. It is clear that although not

statistically significant, weight loss of any kind for this

population has clinical significance and thus is an

important finding. We attribute our lack of statistical

significance to several factors besides the sample size

itself. Unfortunately t-tests with such small means are

not powerful enough to pick up individual differences

in weight loss or changes in waist–hip ratios, as

evidenced by our power analysis. In addition, there

are multiple factors involved in weight loss treatment,

including issues such as motivation, money, transpor-

tation, and availability of healthy foods and activity.

The subjects felt their biggest obstacles to weight loss

were a high crime rate, lack of transportation options,

and low income. Transportation and availability of

healthy foods or activities became significant

obstacles. Fast foods are the most common diet of this

population, and we had to develop creative tools in

helping them to choose the bleast harmfulQ of options.Strategies employed included getting sample menus

from restaurants to discuss, going on walks around the

clinic and local parks, using pedometers and exercise

videos, teaching weight lifting exercises utilizing soup

cans, and discussing types of frozen meals that fit into a

low-calorie diet. It was also interesting that subjects

bforgotQ that they ate the morning of the study and

revealed it later in the day. Obtaining accurate measures

is a challenge in this population.

The Diabetes Prevention Project, which focused on

the prevention of diabetes in individuals with impaired

glucose, was used as a model for this study. It is

noteworthy that both TAU group and treatment group

had evidence of impaired glucose tolerance prior to the

beginning of this study, although only two subjects had

a diagnosis of type 2 diabetes. Impaired glucose

tolerance is a significant and unfortunately a growing

problem in this population with schizophrenia. This

study reinforces the importance of intensive lifestyle

interventions which may also prove to reduce the

incidence of diabetes in this high-risk population.

It is also possible that if the intervention period had

been longer than 16 weeks then more weight loss may

have occurred. Further randomized-controlled trials

with larger samples sizes and longer treatment periods

are planned to learn the best ways to combat this

growing health crisis. The power analysis from this

pilot trial indicates that a sample size of at least 37

would be needed in each group to show statistically

significant weight loss over 16 weeks. We plan to

continue to develop strategies to facilitate weight loss

and to prevent further weight gain in patients treated

with the atypical antipsychotics. We plan to focus on

the population of women with schizophrenia who are

already at highest risk of developing diabetes and

cardiovascular diseases, especially, those who are

Hispanic and African American (Ford et al., 2002;

Meigs, 2003). We hope this research will support

clinicians in providing the highest quality of care to

these individuals who can best benefit from the most

efficacious treatments for their illness

Obesity and its consequences pose a serious health

threat to those with schizophrenia, especially if they are

taking atypical antipsychotics. Cognitive/behavioral

interventions have proven successful in the prevention

of weight gain and diabetes in non-pyschiatric pop-

ulations. This pilot study has demonstrated that weight

loss is possible with cognitive/behavioral interventions

in a population with a psychotic disorder.

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