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Delivery of Brief Cognitive Behavioral Therapy for Medically Ill Patients in
Primary Care: A Pragmatic Randomized Clinical Trial
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* Original Research
* Published: 20 June 2017

DELIVERY OF BRIEF COGNITIVE BEHAVIORAL THERAPY FOR MEDICALLY ILL PATIENTS IN
PRIMARY CARE: A PRAGMATIC RANDOMIZED CLINICAL TRIAL

* Jeffrey A. Cully PhD1,2,3,
* Melinda A. Stanley PhD1,2,3,
* Nancy J. Petersen PhD1,2,
* Natalie E. Hundt PhD1,2,3,
* Michael R. Kauth PhD3,2,1,
* Aanand D. Naik MD1,2,3,
* Kristen Sorocco PhD4,5,
* Shubhada Sansgiry PhD1,2,3,
* …
* Darrell Zeno MS1,2 &
* Mark E. Kunik MD MPH1,2,3

Show authors

Journal of General Internal Medicine volume 32, pages 1014–1024 (2017)Cite this
article

* 3726 Accesses

* 33 Citations

* 24 Altmetric

* Metrics details

ABSTRACT

BACKGROUND

Few studies have examined the practical effectiveness and implementation
potential of brief psychotherapies that integrate mental and physical health.

OBJECTIVE

To determine whether an integrated brief cognitive behavioral therapy (bCBT),
delivered by mental health providers in primary care, would improve depression,
anxiety and quality of life for medically ill veterans.

DESIGN

Pragmatic patient-randomized trial comparing bCBT to enhanced usual care (EUC).

PARTICIPANTS

A total of 302 participants with heart failure and/or chronic obstructive
pulmonary disease (COPD) with elevated symptoms of depression and/or anxiety
were enrolled from two Veterans Health Administration primary care clinics.

INTERVENTION

bCBT was delivered to 180 participants by staff mental health providers
(n = 19). bCBT addressed physical and emotional health using a modular,
skill-based approach. bCBT was delivered in person or by telephone over
4 months. Participants randomized to EUC (n = 122) received a mental health
assessment documented in their medical record.

MAIN MEASURES

Primary outcomes included depression (Patient Health Questionnaire) and anxiety
(Beck Anxiety Inventory). Secondary outcomes included health-related quality of
life. Assessments occurred at baseline, posttreatment (4 months), and 8- and
12-month follow-up.

KEY RESULTS

Participants received, on average, 3.9 bCBT sessions with 63.3% completing
treatment (4+ sessions). bCBT improved symptoms of depression (p = 0.004; effect
size, d = 0.33) and anxiety (p < 0.001; d = 0.37) relative to EUC at
posttreatment, with effects maintained at 8 and 12 months. Health-related
quality of life improved posttreatment for bCBT participants with COPD but not
for heart failure. Health-related quality of life outcomes were not maintained
at 12 months.

CONCLUSIONS

Integrated bCBT is acceptable to participants and providers, appears feasible
for delivery in primary care settings and is effective for medically ill
veterans with depression and anxiety. Improvements for both depression and
anxiety were modest but persistent, and the impact on physical health outcomes
was limited to shorter-term effects and COPD participants.

Clinical trials.Gov identifier: NCT01149772

INTRODUCTION

Depression and anxiety are common in primary care,1 – 3 especially among
medically ill patients.4 – 6 Despite the significant negative impact of
depression and anxiety on patient health, few medically ill patients are
recognized and appropriately treated for their mental health difficulties.3 , 4
Evidence-based psychotherapies (EBPs), including cognitive behavioral therapy
(CBT), exist for depression and anxiety7 but are infrequently used in primary
care clinics.8 , 9

EBPs, which typically involve 12 or more 1-h weekly therapy sessions and do not
integrate physical health components, have proven challenging to implement in
non-mental health settings such as primary care, and access to these services
remains low.10 , 11 Data from the Veterans Health Administration (VHA) found
that only one fourth of veterans with a new mental health diagnosis received at
least one session of psychotherapy and only 10% received four or more sessions
in the year following diagnosis.9

CBT has proven effective for medically ill patients, but studies have used
high-intensity procedures (e.g., weekly sessions over 6 months) that are
difficult to deliver in routine primary care settings.12 Other work, largely
from efficacy trials, suggests that brief CBT may be an effective intervention
for primary care,13 , 14 but bCBT has not addressed the potential integration of
physical health concepts to improve patient engagement, treatment completion and
outcomes.15 – 17 No known studies have tested an integrated physical and mental
health treatment that can address the needs of medically ill patients while
retaining feasibility for use primary care clinics.

This report details the primary outcomes of a pragmatic patient-randomized trial
of bCBT delivered by mental health providers in primary care who agreed to
deliver bCBT as part of routine care practices at two large VHA hospital primary
care clinics. We hypothesized that integrated bCBT would be effective for
depression and anxiety and secondarily for health-related quality of life (QOL).
We also evaluated the implementation potential of bCBT as measured by provider
intervention fidelity and patient-participant treatment initiation and
completion.

METHODS

The study used a parallel, patient-randomized clinical trial design to
understand bCBT effectiveness and implementation potential.18 , 19 Data were
collected at the Michael E. DeBakey (Houston) and Oklahoma City VA Medical
Centers. The study was approved by local institutional review boards at both
facilities. Participants were consented and compensated $110 for study
assessments ($20 for baseline and $30 for 4-, 8- and 12-month follow-ups). Study
enrollment began in February 2011 and ended in November 2013.

PARTICIPANT SAMPLE

The study used VHA databases and follow-up medical-record reviews to identify
participants with a diagnosis of heart failure (HF; ICD-9 codes 398.91, 402.01,
402.11, 402.91, 404.01, 404.03, 404.11, 404.13, 404.91, 404.93, 428, 428.10,
428.9) or chronic obstructive pulmonary disease (COPD; ICD-9 codes 490, 491,
492, 493, 496, 508).20 , 21 Opt-out letters were mailed to all veterans with a
chart diagnosis of HF and/or COPD who were actively enrolled with a primary care
provider. Study staff contacted potential participants up to three times.
Interested participants completed a telephone screening and were included if
they (1) reported depression or anxiety symptoms using a five-item PRIME-MD
screener (2 items for depression; 3 items for anxiety)22 and (2) screened
positive for mild or greater functional impairment, as determined by the Medical
Research Council dyspnea scale (score ≥3)23 , 24 and/or the New York Heart
Association classification (class 2 or greater).25 Participants were also
required to screen negative for cognitive impairment,26 current substance abuse
and psychotic and bipolar disorder (Mini-International Neuropsychiatric
Interview)27 and could not have active intent or a plan to commit suicide.
Participants with suicidal ideation, without intent or plan, were eligible.

Final eligibility was determined during a baseline evaluation that required
elevated symptoms of anxiety [Beck Anxiety Inventory (BAI) score of ≥16]28
and/or depression (Patient Health Questionnaire; PHQ-9 score of ≥10).29 Before
randomization, a medical-record review confirmed that participants were not
receiving any competing psychotherapy interventions.

EFFECTIVENESS MEASURES AND DATA COLLECTION

Participants provided demographic information, including race/ethnicity, during
the baseline evaluation. All randomized participants received an evaluation at
4, 8 and 12 months by independent evaluators masked to participant randomization
group. The 4-month evaluation represented the immediate posttreatment
assessment.

PRIMARY OUTCOMES—DEPRESSION AND ANXIETY

Depression was assessed using the Patient Health Questionnaire (PHQ-9),30 a
widely used and psychometrically strong nine-item measure. Scores range from 0
to 27, with scores ≥10 suggesting the presence of clinically significant
depression. PHQ-9 treatment response was defined as a 50% reduction in total
score or a total score of 9 or less indicating minimal or less symptoms.30

Anxiety was assessed using the Beck Anxiety Inventory (BAI),31 a reliable,
valid, 21-item measure. Scores on the BAI range from 0 to 63, with scores
between 16 and 25 indicating moderate anxiety and scores ≥26 indicating severe
anxiety. Treatment response for the BAI was defined as either (1) a 50%
reduction in total score or (2) mild or lower total score (e.g., score below
16).

SECONDARY OUTCOMES—HEALTH-RELATED QOL

Participants with COPD completed the Chronic Respiratory Questionnaire (CRQ), a
well-validated, 20-item self-report instrument with four subscales: dyspnea,
fatigue, emotional functioning and mastery.32 Higher scores reflect better
functioning, and an increase of 0.5 on any subscale score indicates a minimally
clinically important difference.33 Participants with HF completed the Kansas
City Cardiomyopathy Questionnaire (KCCQ34), a 23-item self-report inventory
frequently used in cardiology trials to assess change in physical limitations,
HF symptoms, self-efficacy, QOL and social limitations.35 The KCCQ overall
summary score (OSS) was used, with higher scores reflecting improvement; an
increase of 5 points was used to define response.36 Participants with both COPD
and HF completed both instruments.

CONTROLLING VARIABLES

VHA patient administrative databases provided participants’ healthcare
utilization information. Data were examined for three 4-month periods: baseline
to 4 months, 4 to 8 months and 8 to 12 months.

DEPRESSION AND ANXIETY MEDICATIONS

Changes in depression and/or anxiety medications were assessed at each time
period for (1) the start of an anxiety or depression medication, (2) change in
the dose of an existing medication or (3) a change in medication type. A
dichotomous indicator variable (yes/no) was used to define active medication
management.

MENTAL HEALTH AND PRIMARY CARE VISITS

Current Procedural Terminology codes were used to identify mental health
services (90801–90,911; 96,100–96,155). Primary care and specialty medical care
visits were identified using VHA outpatient clinic stop codes. Visits were
collected using count data (e.g., number of visits) during each of the three
study time periods.

INTERVENTION AND INTERVENTION PROVIDERS

Mental health providers and advanced trainees recruited from primary care
settings delivered the bCBT. Providers were approached if psychotherapy was part
of their scope of practice. Participating providers (n = 19) included six
psychologists, two social workers, two physician assistants, six psychology
fellows and three psychology interns. Providers received bCBT training and
support including (1) access to an online bCBT training program, (2) session
feedback and (3) facilitation to support bCBT use in primary care.37

bCBT was delivered in six weekly/biweekly sessions and two telephone “booster”
sessions over 4 months. Participants attended the first session in person and
could participate by telephone thereafter. Providers followed a manual.
Patient-participants received a workbook to guide session content. Information
about development and clinical content of the intervention can be found
elsewhere.20 , 38 Intervention materials are available for public download
through a VA website, including the provider manual39 and patient workbook.40

Providers and participants collaboratively determined the number and type
(in-person or telephone) of sessions, depending on clinical need, provider
availability and patient-participant preferences for care. bCBT content targeted
management of physical and emotional symptoms. Integration of physical health
occurred throughout the intervention. Providers reviewed life stressors, prior
coping efforts, current strengths and resources to support improvements in both
physical and emotional health. Providers also used structured goal setting and
action-planning assignments to align physical and emotional health targets.

A menu of bCBT skill sessions was offered. Skills were selected to meet the
individual needs of the patient-participant. Not all participants received all
skill types. Skill sessions included (1) identification and modification of
maladaptive thinking, (2) behavioral activation, (3) relaxation and (4) chronic
disease self-management (CDSM), including diet/nutrition, exercise, managing
medications, talking to your doctor and coping with exacerbations. Although CDSM
skills addressed physical health concerns directly, other skills could address
emotional or physical health concerns. For example, maladaptive thinking skills
could address negative views related to coping with either physical or emotional
health issues, behavioral activation could address physical activity (exercise)
or pleasant events, and relaxation could address anxiety experiences or aid in
coping with worry associated with physical health.

INTERVENTION FIDELITY

Providers delivered care to an average of 9.5 participants (median of 7; range
1–25). Sessions were audio recorded to assess fidelity and provide feedback to
providers. Two experienced clinical psychologists (MS and NH) rated sessions for
adherence and competence, using an established scale.41 Scores ranged from 1–8,
with 4–5 considered “moderately” adherent/competent and 6, 7 and 8 classified as
good, very good and excellent, respectively. The project collected 602 audio
recordings and reviewed 137 (23%) for fidelity. Raters reviewed an average of
7.2 sessions for each provider. Mean adherence and competence ratings for all
providers fell in the “good”-to-“very-good” range (adherence 6.7, competence
6.2).

TREATMENT DELIVERY AND IMPLEMENTATION POTENTIAL

Data on participant treatment utilization of bCBT was collected from chart
reviews for all bCBT participants. bCBT initiation was defined as attending one
or more sessions and completion as receipt of four or more sessions.
Implementation data were collected from bCBT veteran participants
(posttreatment) and providers (after 6 months of bCBT delivery).

PARTICIPANT RANDOMIZATION

Once eligible, participants had been randomized to enhanced usual care (EUC) or
bCBT, with 60% of participants going to bCBT and 40% to EUC. Unequal
randomization was used to increase statistical power given the need to adjust
for provider effects.42 Random number lists were created, using blocks of ten
for three participant groups: COPD, HF and a group with both conditions. The
study coordinator randomly assigned participants using sealed envelopes.

Participants in EUC received an assessment for depression and anxiety with a
note placed in their electronic medical record encouraging providers to address
these difficulties as part of their standard care practices.

DATA ANALYSES

Primary analyses examined posttreatment differences between bCBT and EUC for
depression (PHQ-9), anxiety (BAI) and health-related QOL (CRQ and KCCQ). The
posttreatment outcome served as the dependent variable for the generalized
linear models, with treatment group as the independent variable. Control
variables included the baseline value for the outcome, the participant’s
diagnosis of COPD and/or HF, baseline functional score (MRC or NYHA), depression
and anxiety medication, and primary care and mental health visits for baseline
to 4 months. Participants were nested within site.

Analyses were intention to treat (ITT), using multiple imputation procedures in
SAS version 9.4 (SAS Institute, Inc., Cary, NC) to handle missing values. For
missing data, the Markov Chain Monte Carlo method was used.43 We calculated the
effect size, d, at 4 months, using the mean values from the estimated means and
standard errors from linear model analyses of the imputed data sets. The 95%
confidence interval for the effect size was calculated using formulas from
Howell.44 Treatment response data were analyzed using “number needed to treat”
(NNT) on the primary outcome measures.

Longitudinal analyses examined long-term outcomes, using a repeated measures
linear mixed model. The outcome at 8 or 12 months served as the dependent
variable. The model included terms for treatment group (bCBT or EUC), time (8 or
12 months) and the time-by-treatment interaction. Control variables included in
the 4-month model were used for 8- and 12-month analyses. Participants were
nested within site, and critical α for testing significance was set at p ≤ 0.05.
All tests were two-sided.

Responder analyses focused on participants who met criteria for elevated
baseline symptoms of depression and anxiety separately. For COPD and HF-related
functioning, all participants completing the CRQ or KCCQ were included.
Differences between treatment groups were tested by combining the chi-square
analyses for the imputed data sets.45 , 46 We also conducted chi-square
completer analyses using observed data with missing data excluded.

Implementation analyses were restricted to descriptive data for intervention
fidelity, bCBT initiation and completion rates, and survey responses from
providers and bCBT patient-participants.

SAMPLE SIZE

The sample-size calculations examined differences in primary and secondary
outcomes. To ensure 80% power at the 0.05 level, adjusting for repeated measures
and intraclass correlations related to clustering of participants within
providers, a sample size of 240 was needed. Given a potential 25% attrition, a
final sample of 320 participants was estimated. Attrition was defined as being
lost to follow-up (e.g., did not complete study assessments). The recruited
sample of 302 participants was 94% of target.

RESULTS

SAMPLE SELECTION AND ATTRITION

Of 8835 eligible participants, 1387 completed screening; 432 completed a
baseline assessment (Fig. 1). Of these, 130 were excluded before randomization
with the majority having subclinical scores on the BAI and PHQ-9 (n = 122). A
total of 302 participants were randomized, 180 to bCBT and 122 to EUC.

Fig. 1

Participant recruitment

Full size image

The two groups did not differ significantly in proportion of participants
completing the 4-month assessment [bCBT 73.3% (132/180), EUC 82.7% (101/122),
p = 0.09]. Attrition for 8 and 12 months was comparable for bCBT and EUC. Total
attrition at 12-month follow-up was 25.8% (n = 78). Reasons for dropout are
shown in Fig. 1. Analyses indicated no significant differences between
completers and noncompleters.

Participants did not differ significantly on baseline sociodemographic and
clinical characteristics by intervention status (Table 1). Participant mean age
was 65.5, and over 90% were male. Of those randomized, 62% had COPD, 25% had HF,
and 13% had both. Over 85% of participants had elevated depression symptoms,
75.5% had elevated anxiety symptoms, and 62.9% had both. A total of 180 (59.6%)
participants met criteria for a diagnosis of depression or anxiety according to
the MINI, and 103 participants received an antianxiety or antidepressant
medication or medication change during the 90 days before baseline (Fig. 2).

Table 1 Baseline Sociodemographic and Clinical Characteristics by Intervention
Status
Full size table
Fig. 2

Flow of participants through each phase of the study

Full size image

INTERVENTION DATA

Participants randomized to bCBT (n = 180) received, on average, 3.9 sessions
(SD = 2.3), 152 (84.4%) received 1 or more sessions, 114 (63.3%) were classified
as treatment completers (4 or more sessions), and 62 (34.4%) completed 6
sessions. Of participants who received 1 or more sessions, the mean was 4.6 (SD
1.6) and median was 5. Telephone delivery occurred in 60.3% of sessions.

Data on EUC mental health treatment were collected using VHA databases. At
4 months, 32 (26%) of EUC participants had received one or more mental health
encounters, 6 (4.92%) had received one or more, and 3 (2.46%) had received four
or more psychotherapy sessions. With regard to medications, additions or changes
to antianxiety and antidepressant medication during the 4-month treatment period
occurred in 61 (56.0%) of bCBT and 48 (44.0%) of EUC participants (chi-square p
value = 0.33).

POSTTREATMENT OUTCOMES (0–4 MONTHS; TABLE 2)

Table 2 contains the mean observed scores at baseline and 4 months. Relative to
EUC, participants who received bCBT demonstrated greater improvements, except
for HF QOL. bCBT participants realized a small-to-medium treatment effect for
anxiety (BAI; d = 0.37) and depression (PHQ-9; d = 0.33). Subgroup analyses
found no differences between COPD and HF groups in depression or anxiety
outcomes. For COPD participants, improvements were seen for dyspnea (d = 0.21),
emotion (d = 0.46), mastery (d = 0.43) and fatigue (d = 0.35). No significant
treatment effects were noted for HF QOL (d = 0.05).

Table 2 Main Outcomes: Mean Observed Scores and Intention-to-Treat Analyses of
Outcome Measures for Baseline to 4 Months for Participants Receiving CBT or
Enhanced Usual Care
Full size table

The number needed to treat (NNT) was calculated using responder data for
depression and anxiety separately. The NNT for anxiety was 6.30 (medium effect)
and for depression was 6.10 (medium effect).

LONG-TERM OUTCOMES (4–12 MONTHS; TABLE 3)

Covariate-adjusted posttreatment differences between bCBT and EUC continued over
the follow-up period for the BAI and PHQ-9 total score and indicated the initial
treatment effect was maintained but not improved. Posttreatment effects were not
maintained for the CRQ subscales, and no changes were identified for KCCQ over
the 12-month follow-up period.

Table 3 Mean Observed Scores and Intention-to-Treat Analyses of Outcome Measures
for Follow-up at 8 to 12 Months for Participants Receiving CBT or Enhanced Usual
Care
Full size table

TREATMENT RESPONSE (TABLE 4)

ITT responder analyses indicated a change, relative to EUC, for anxiety
(p = 0.05) and depression (p = 0.03) at 4 months with nonsignificant differences
at 12 months (p = 0.15 and 0.42, respectively). Combining response for BAI and
PHQ-9, we found that 50% of the bCBT group responded at 4 months (relative to
32.8% in EUC; p = 0.007) and 45% responded at 12 months (relative to 37.7% in
EUC; p = 0.40).

Table 4 Response Rate Among Participants with Clinically Elevated Depression or
Anxiety
Full size table

IMPLEMENTATION POTENTIAL: PROVIDER AND PATIENT-PARTICIPANT SURVEY DATA (TABLE 5)

Providers reported high levels of satisfaction with bCBT (100% of respondents),
found use of bCBT to be consistent with current evidence-based practices (100%
agreement) and viewed the bCBT as being well suited for use within the primary
care setting (94% agreement). bCBT patient-participants were mostly or very
satisfied with the amount of assistance received (90% of respondents), found the
program met most or all their needs (79% or respondents) and indicated that
telephone sessions were somewhat or very important (83% or respondents).

Table 5 Provider and Patient-Participant Post-bCBT Survey Data
Full size table

DISCUSSION

The current pragmatic trial documented the effectiveness and implementation
potential of physical and emotional health integrated bCBT for medically ill
veterans with depression and/or anxiety treated in the primary care setting.
Implementation data suggested robust delivery of the intervention by providers,
with high levels of participant engagement and adherence. Integrated bCBT
resulted in significant and clinically important improvements for depression and
anxiety, with short-term effects for physical health outcomes for participants
with COPD.

The VHA and other healthcare organizations have dedicated significant resources
to re-align primary care with specific efforts to integrate mental health
services into a broader multi-professional approach to care.47 , 48
Unfortunately, significant practice gaps exist with regard to mental health
interventions addressing physical health needs of patients while also retaining
a feasible delivery model for dissemination.

In addition to its primary clinical effectiveness outcomes, our data show the
potential for bCBT to improve access and engagement with psychotherapy in
primary care. National data on mental health services and psychotherapy use
suggest that access to evidence-based care remains limited. Wang et al.49 found
that 14.3% of a nationally representative sample of mental health patients
received evidence-based treatment. Among veterans with a newly diagnosed mental
health condition, only 27% received one or more and 11% received four or more
psychotherapy sessions.9 Although data from the current study must be
interpreted with caution given the research approach used (e.g., participant
vetting), delivery was robust with 84.4% of participants receiving one or more
bCBT sessions and 63.3% completing treatment (4+ sessions).

Significant strengths of this study include the pragmatic trial design that used
clinical providers for delivering treatment, a large and diverse participant
sample from multiple sites, long-term follow-up and comprehensive publically
available intervention training and materials.

Study outcomes should be interpreted with the following limitations. First,
although this trial used limited exclusion criteria, participants completed
screening procedures before randomization and may represent a more curated
sample than found in frontline practice. Second, retention of bCBT participants
at 4 months was somewhat lower than for EUC, likely because of the increased
burden associated with treatment. Third, bCBT outcomes were maintained for
depression and anxiety outcomes but generally not maintained for physical health
QOL at 12 months. These outcomes suggest that delivery of a bCBT treatment, with
an average of less than 4 sessions, may not be enough to sustain longer-term
impact in chronic, progressive medical illnesses. Future efforts may require
sustained interventions and/or community resources (e.g., peer support or other
care management services) to maintain coping and self-management activities.
Additional studies also need to better understand the differential impact of the
intervention on COPD and HF QOL.

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ACKNOWLEDGEMENTS

This material is the result of work supported by the Department of Veterans
Affairs, Health Services Research & Development Grant no. 09-088, the VA South
Central Mental Illness Research Education and Clinical Center, and the resources
and facilities of the Houston VA HSR&D Center for Innovations in Quality,
Effectiveness and Safety (CIN13-413). The funding organizations played no role
in the design and conduct of the study; collection, management, analysis and
interpretation of the data; preparation, review or approval of the manuscript;
or decision to submit the manuscript for publication. The authors thank the
providers and leadership of the Michael E. DeBakey VA Medical Center and the
Oklahoma City VA Medical Center and also Joseph Mignogna, PhD; Lisa Kearney,
PhD; Andrew Pomerantz, MD; and Joanne Kirchner, MD, for their consultation and
collaborations. Jeffrey Cully had full access to the data in the study and takes
responsibility for the integrity of the data and the accuracy of the data
analysis. Data analyses were completed by Shubhada Sansgiry, PhD, and Nancy
Petersen, PhD. The opinions expressed are those of the authors and not
necessarily those of the Department of Veterans Affairs, the US government or
Baylor College of Medicine.

AUTHOR INFORMATION

AFFILIATIONS

1. Houston VA HSR&D Center for Innovations in Quality, Effectiveness and
Safety, Michael E. DeBakey VA Medical Center, 2002 Holcombe Blvd., Houston,
TX, 77030, USA

Jeffrey A. Cully PhD, Melinda A. Stanley PhD, Nancy J. Petersen PhD, Natalie
E. Hundt PhD, Michael R. Kauth PhD, Aanand D. Naik MD, Shubhada Sansgiry
PhD, Darrell Zeno MS & Mark E. Kunik MD MPH

2. Baylor College of Medicine, Houston, TX, USA

Jeffrey A. Cully PhD, Melinda A. Stanley PhD, Nancy J. Petersen PhD, Natalie
E. Hundt PhD, Michael R. Kauth PhD, Aanand D. Naik MD, Shubhada Sansgiry
PhD, Darrell Zeno MS & Mark E. Kunik MD MPH

3. VA South Central Mental Illness Research, Education and Clinical Center (a
virtual center), Houston, TX, USA

Jeffrey A. Cully PhD, Melinda A. Stanley PhD, Natalie E. Hundt PhD, Michael
R. Kauth PhD, Aanand D. Naik MD, Shubhada Sansgiry PhD & Mark E. Kunik MD
MPH

4. Oklahoma City VA Healthcare System, Oklahoma City, OK, USA

Kristen Sorocco PhD

5. University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA

Kristen Sorocco PhD

Authors
1. Jeffrey A. Cully PhD
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2. Melinda A. Stanley PhD
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3. Nancy J. Petersen PhD
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4. Natalie E. Hundt PhD
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5. Michael R. Kauth PhD
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6. Aanand D. Naik MD
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7. Kristen Sorocco PhD
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8. Shubhada Sansgiry PhD
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9. Darrell Zeno MS
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10. Mark E. Kunik MD MPH
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CONTRIBUTIONS

Study conception or design—all authors

Acquisition, analysis, or interpretation of data—all authors

Drafting of manuscript—all authors

Critical revision of manuscript for important intellectual content—all authors

CORRESPONDING AUTHOR

Correspondence to Jeffrey A. Cully PhD.

ETHICS DECLARATIONS

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The authors declare that they do not have a conflict of interest.

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Cully, J.A., Stanley, M.A., Petersen, N.J. et al. Delivery of Brief Cognitive
Behavioral Therapy for Medically Ill Patients in Primary Care: A Pragmatic
Randomized Clinical Trial. J GEN INTERN MED 32, 1014–1024 (2017).
https://doi.org/10.1007/s11606-017-4101-3

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* Received: 16 March 2016

* Revised: 06 April 2017

* Accepted: 02 June 2017

* Published: 20 June 2017

* Issue Date: September 2017

* DOI: https://doi.org/10.1007/s11606-017-4101-3

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KEY WORDS

* clinical trial
* cognitive behavioral therapy
* primary care
* veterans
* heart disease
* COPD

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* Abstract
* Introduction
* Methods
* Results
* Discussion
* References
* Acknowledgements
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CAS Article PubMed PubMed Central Google Scholar

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Int J Psychiatry Med. 2012;43:129–51.

Article PubMed PubMed Central Google Scholar

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CAS Article PubMed PubMed Central Google Scholar

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trial of collaborative care in patients with diabetes and depression. JAMA
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17. Rollman BL, Belnap BH, LeMenager MS, et al. Telephone-delivered
collaborative care for treating post-CABG depression: A randomized
controlled trial. JAMA. 2009;302(19):2095–2103.

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Article PubMed PubMed Central Google Scholar

Google Scholar

21. Spitzer RL, Williams JBW, Kroenke K, et al. Utility of a new procedure for
diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA.
1994;272(22):1749–1756.

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anxiety and depression in patients with chronic breathing disorders.
Psychosomatics. 2007; 48: 16–21.

Article Google Scholar

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NYHA classes for measuring research outcomes in patients with cardiac
disease. Heart Lung. 2002;31(4):262–70.

Article Google Scholar

26. Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item
screener to identify cognitive impairment among potential subjects for
clinical research. Med Care. 2002;40(9):771–81.

Article Google Scholar

PubMed Google Scholar

28. Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical
anxiety: Psychometric properties. J Consult Clin Psychol. 1988;56:893–897.

CAS Article PubMed Google Scholar

29. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report
version of PRIME-MD: The PHQ Primary Care Study. JAMA.
1999;282(18):1737–1744.

CAS Article PubMed Google Scholar

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depression severity measure. J Gen Intern Med. 2001;16(9):606–13.

CAS Article PubMed PubMed Central Google Scholar

31. Beck AT, Steer RA. Manual for the Beck Anxiety Inventory. San Antonio, TX:
Psychological Corporation; 1990

Google Scholar

32. Guyatt GH, Berman LB, Townsend M, Pugsley SO, Chambers LW. A measure of
quality of life for clinical trials in chronic lung disease. Thorax.
1987;42(10):773–8.

CAS Article PubMed PubMed Central Google Scholar

33. Jaeschke R, Singer J, Guyatt G. Measurement of health status: Ascertaining
the minimally clinically important difference. Control Clin Trials.
1989;10(4):407–415.

CAS Article PubMed Google Scholar

35. Krumholtz HM. Outcomes research: Generating evidence for best practices and
policies. Circulation. 2008;118:309–318

Article Google Scholar

36. Spertus J, Peterson E, Conard MW, et al. Monitoring clinical changes in
patients with heart failure: A comparison of methods. Am Heart J.
2005;150(4):707–715.

Article PubMed Google Scholar

37. Mignogna J, Hundt N, Kauth MR, et al. Implementing brief cognitive
behavioral therapy in primary care: A pilot study. Transl Behav Med.
2014;4(2):175–183.

Article PubMed Central Google Scholar

38. Cully JA, Paukert A, Falco J, Stanley MA. Cognitive-behavioral therapy:
Innovations for cardiopulmonary patients with depression and anxiety. Cogn
Behav Pract. 2009;16:394–407.

Article Google Scholar

Article PubMed PubMed Central Google Scholar

42. Schnurr PP, Friedman MJ, Engel CC, et al. Issues in the design of multisite
clinical trials of psychotherapy: VA Cooperative Study No. 494 as an
example. Contemp Clin Trials. 2006;26:626–36.

Article Google Scholar

43. (eds). SAS (Stat 9.2) user’s guide, Second Edition.

45. Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York: John
Wiley and Sons; 1987.

Book Google Scholar

46. Li KH, Meng XL, Raghunathan TE, Rubin DB. Significance levels from repeated
p-values with multiply-imputed data. Statistica Sinica. 1991;1:65–92.

Google Scholar

48. Zeiss AM, Karlin BE. Integrating mental health and primary care services in
the Department of Veterans Affairs Health Care system. J Clin Psychol Med
Settings. 2008;15(1): 73–78.

Article PubMed Google Scholar

49. Wang PS, Berglund P, Kessler RC. Recent care of common mental disorders in
the United States: Prevalence and conformance with evidence-based
recommendations. J Gen Intern Med.2000;15:284–292.

CAS Article PubMed PubMed Central Google Scholar

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