DEPRESSION AND ANXIETY 31:391–401 (2014)

Research Article
LAY PROVIDERS CAN DELIVER EFFECTIVE COGNITIVE
BEHAVIOR THERAPY FOR OLDER ADULTS WITH
GENERALIZED ANXIETY DISORDER: A RANDOMIZED
TRIAL
Melinda A. Stanley, Ph.D.,1,2,3 ∗ Nancy L. Wilson, M.S.W.,1,2 Amber B. Amspoker, Ph.D.,1,2
Cynthia Kraus-Schuman, Ph.D.,3,4 Paula D. Wagener, B.A.,1,2 Jessica S. Calleo, Ph.D.,1,2,3,4 Jeffrey A. Cully,
Ph.D.,1,2,3,4 Ellen Teng, Ph.D.,1,2,3,4 Howard M. Rhoades, Ph.D.,5 Susan Williams, M.D.,2 Nicholas Masozera,
M.D.,3,4 Matthew Horsfield, M.D.,2 and Mark E. Kunik, M.D., M.P.H.1,2,3,4

Background: The Institute of Medicine recommends developing a broader work-

force of mental health providers, including nontraditional providers, to expand
services for older adults. Cognitive behavior therapy (CBT) is effective for late-life
generalized anxiety disorder (GAD), but no study has examined outcomes with
delivery by lay providers working under the supervision of licensed providers.
The current study examined the effects of CBT delivered by lay, bachelor-level
providers (BLP) relative to Ph.D.-level expert providers (PLP), and usual care
(UC) in older adults with GAD. Methods: Participants were 223 older adults
(mean age, 66.9 years) with GAD recruited from primary care clinics at two sites
and assigned randomly to BLP (n = 76), PLP (n = 74), or UC (n = 73). Assess-
ments occurred at baseline and 6 months. CBT in BLP and PLP included core
and elective modules (3 months: skills training; 3 months: skills review) delivered
in person and by telephone, according to patient choice. Results: CBT in both
BLP and PLP groups significantly improved GAD severity (GAD Severity Scale),
anxiety (Spielberger State-Trait Anxiety Inventory; Structured Interview Guide
for the Hamilton Anxiety Scale), depression (Patient Health Questionnaire),
insomnia (Insomnia Severity Index), and mental health quality of life (Short-
Form-12), relative to UC. Response rates defined by 20% reduction from pre- to
posttreatment in at least three of four primary outcomes were higher for study

1 Houston VA HSR&D Center for Innovations in Quality, Effec-

tiveness and Safety, Houston, Texas
2 Baylor College of Medicine, Houston, Texas
3 South Central Mental Illness Research, Education and Clinical
Center (A Virtual Center), Houston, Texas
4 Michael E. DeBakey VA Medical Center, Houston, Texas
5 Harris County Psychiatric Center, The University of Texas
Health Science Center at Houston, Houston, Texas
Conflict of interest. All the authors declare no conflicts of interest.
Trial Registration: ClinicalTrials.gov. NCT00765219, http://clinical
trials.gov/ct2/show/NCT00765219?term=Melinda+Stanley&rank=5
Grant sponsor: National Institute of Mental Health; Grant number:
R01-MH53932, Supported in part by the Houston VA HSR&D Cen-
ter for Innovations in Quality, Effectiveness and Safety; (CIN-13-
413).
∗ Correspondence to: Melinda A. Stanley, Menninger Department of
Psychiatry and Behavioral Sciences, Baylor College of Medicine,
Houston VA Center for Innovations in Quality, Effectiveness and
Safety (MEDVAMC 152), 2002 Holcombe Boulevard, Houston, TX
77030.
E-mail: mstanley@bcm.tmc.edu
Received for publication 13 September 2013; Revised 27 Decem-
ber 2013; Accepted 7 January 2014
DOI 10.1002/da.22239
Published online 27 February 2014 in Wiley Online Library
(wileyonlinelibrary.com).

Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
392
completers in BLP and PLP relative to UC (BLP: 38.5%; PLP: 40.0%; UC:
19.1%). Conclusion: Lay providers, working under the supervision of licensed
providers, can deliver effective CBT. Depression and Anxiety 31:391–401, 2014.
Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
Key words: psychotherapy; controlled clinical trial; mental health
INTRODUCTION
T he growing number of older adults needing mental
health care is expected to reach 10–14 million by 2030.[1]
Current and future needs far surpass the available work-
force of providers trained in geriatric mental health care.
Recent Institute of Medicine (IOM) recommendations
include developing novel models of care to reduce bar-
riers and expand reach of mental health services for
this group, some of which rely heavily on developing a
broader workforce including nontraditional healthcare
providers.[1,2, 3] Nontraditional providers (e.g., commu-
nity health workers, lay providers) are valuable for ex-
panding access to care, particularly among low-income,
underserved older adults;[4–6] but limited data address
their role in delivering mental health interventions.[7, 8]
Recent literature reviews[9, 10] and clinical trials[8, 11] sug-
gest that psychosocial treatments of anxiety and de-
pression delivered by experts and nonexperts produce
comparable outcomes, with potential economic and lo-
gistic advantages for nonexperts. Studies in late-life de-
pression have tested interventions delivered by trained
providers with varying levels of healthcare expertise (so-
cial workers, clinical case managers, nurses, etc.).[12–14]
However, no study has trained lay providers inexperi-
enced in health care to deliver anxiety or depression
care for older adults under the supervision of licensed
providers and compared outcomes with those achieved
by expert providers.
Anxiety disorders occur frequently among older adults
(12–15%).[15, 16] Generalized anxiety disorder (GAD) is
particularly common (up to 7% )[15–18] and the focus
of most late-life anxiety research. GAD is associated
with increased disability,[19–21] medical comorbidity,[22]
memory difficulties,[23] sleep disturbance,[24] reduced
quality of life,[25–27] and increased service use.[26]
Pharmacological and cognitive behavioral therapy
(CBT) are both effective for late-life GAD,[28–31] but
many older people prefer psychosocial treatment.[32–35]
Recent studies have focused on broadening reach by
testing CBT for GAD in primary care settings, where
older adults often receive mental health care, and by
examining alternative delivery options (e.g., modular
treatment, telephone delivery).[36–39] Despite positive
outcomes for these treatments, all studies have used
experienced or highly trained anxiety specialists, severely
limiting implementation readiness and access to afford-
able care.[2, 40] In light of IOM recommendations, the
current study examined outcomes following CBT for
late-life GAD in primary care when bachelor-level lay
Depression and Anxiety
Stanley et al.
providers (BLPs) without healthcare experience pro-
vided care under the supervision of experts and compared
them with results of experienced Ph.D.-level providers
(PLPs) and usual care (UC). We expected that outcomes
at 6 months (posttreatment) would be similar in the BLP
and PLP groups and improved relative to UC. These
data extend findings from a pilot study that showed pos-
itive outcomes for care delivered by nonexpert providers,
but sample size was small (n = 19), no control group was
included, and treatment integrity raters were not blind
to therapist experience.[41]
METHOD
Institutional review boards at Baylor College of Medicine (BCM)
and the Michael E. DeBakey Veterans Affairs Medical Center
(MEDVAMC) approved the study. After description of study proce-
dures, participants provided written informed consent. Included par-
ticipants received $20 for each completed assessment.
PARTICIPANTS
From October 2008 to April 2012, we recruited patients, age 60
years and older, whose symptoms met diagnostic criteria for principal
or coprincipal GAD,[42] through internal medicine, family practice,
and geriatric clinics at MEDVAMC and BCM.[43] We placed educa-
tional brochures in waiting and examination rooms to facilitate patient
self-referral and used the electronic medical record (EMR) to iden-
tify other potential participants, in collaboration with primary care
providers (PCPs). Criteria for participation included an EMR diag-
nosis of GAD or Anxiety Not Otherwise Specified, anxiety symptoms
in the problem list, and prescriptions for antianxiety or antidepressant
medication. Patients identified by the EMR and approved by the PCPs
received a letter from their PCP and the study principal investigator
(MAS) inviting them to participate. We then telephoned patients who
did not call to decline participation to discuss the study.
Patients expressing interest were asked two PRIME-MD anxiety
screening questions.[44] Those responding affirmatively to at least one
question were scheduled for an in-person visit to review consent, repeat
the anxiety screener, and complete a demographic questionnaire.[1]
At this meeting or a subsequent appointment, the six-item Cogni-
tive Screener[45] and the Structured Clinical Interview for DSM-IV
Disorders (SCID)[46] were administered by Master’s level expert in
late-life anxiety. All SCID interviews were audiotaped and supervised
by the first author, and a random 20% were rated by a second expert
to assess interrater agreement. Kappa coefficients indicated adequate-
to-excellent agreement for GAD (.69), depression (major depression
or dysthymia; .91), and other anxiety disorders (.76).
Inclusion criteria were (1) principal or coprincipal DSM-IV diag-
nosis of GAD of at least moderate severity (4 on 0–8 scale,) according
to the SCID;[2] (2) ability to speak English, although not necessarily
as the first language; and (3) current psychosocial or pharmacolog-
ical treatment allowed but psychotropic medication stable over the
prior month. Exclusion criteria included presence of conditions that
 Research Article: Lay Provider Delivery of CBT for GAD: An RCT
threatened patient safety or precluded participation: active suicidal in-
tent; current psychosis or bipolar disorder; substance abuse within the
past month; and cognitive impairment, defined as three or more missed
items on the six-item Cognitive Screener.[45]
RANDOMIZATION
Within each study site, patients were randomly assigned according
to a 1:1:1 ratio within blocks of nine to BLP, PLP, or UC. The study
statistician (HMR) generated a stratified randomization scheme using
a random number generator. Upon completion of baseline assessment,
the study manager assigned the participant to a treatment condition.
An interim randomization check (n = 169 baselines completed) re-
vealed a significant association between baseline Penn State Worry
Questionnaire Abbreviated (PSWQ-A) scores and treatment assign-
ment (χ 2 (2) = 6.47, P = .039), with more patients with high PSWQ-A
scores (≥26) in BLP (34/81; 42%) than PLP (25/81; 31%) and UC
(22/81; 27%). To mitigate this, remaining patients were assigned to
treatment with additional stratification based on baseline PSWQ-A
score (cut score = 26).
MEASURES AND DATA COLLECTION
Primary Outcomes. Primary outcomes included self-report and
clinician-rated measures of worry and anxiety. Self-reported worry
severity was measured with the PSWQ-A,[46, 47] an eight-item instru-
ment derived from the original 16-item PSWQ,[48–50] used widely in
clinical trials of late-life GAD.[36, 39, 51] Clinician-rated worry/GAD
severity was evaluated with the Generalized Anxiety Disorder Severity
Scale (GADSS),[52] a six-item scale that assesses DSM-IV criteria and
has adequate psychometric properties among older adults.[53, 54]
Anxiety severity was assessed with the trait subscale of the Spiel-
berger State-Trait Anxiety Inventory (STAI-T)[55] and the Structured
Interview Guide for the Hamilton Anxiety Scale (SIGH-A).[56] The
STAI-T is a 20-item self-report measure of general anxiety, used com-
monly among older adults[57] and demonstrating sensitivity to change
following treatment.[36, 58] The SIGH-A is a clinician-rated measure
developed to increase reliability of the Hamilton Anxiety Scale,[59]
with demonstrated sensitivity to change in clinical trials.[36]
Secondary Outcomes. Depressive symptoms were assessed with
the Patient Health Questionnaire-8 (PHQ-8),[60] an eight-item ver-
sion of the PHQ-9[61] that omits the item assessing suicide. Psycho-
metric properties of the PHQ-9 are strong among older adults,[61]
and the two versions of the scale highly correlated.[60] Insomnia was
evaluated with the Insomnia Severity Index (ISI),[62] a seven-item,
self-report measure based on DSM-IV criteria for insomnia. The ISI
has good concurrent validity[62] and is sensitive to change following
treatment.[36] Physical/mental health quality of life was measured with
the 12-item Medical Outcomes Study Short Form,[63] which produces
two summary scores, mental (MCS) and physical (PCS).[64] Reliability
and validity have been demonstrated in older adults,[65] with the MCS
sensitive to change following treatment.[39]
Psychotropic Medication Use. Self-report questions about
type and frequency of medications used over the prior 3 months[66]
assessed psychotropic medication use. Of particular interest were med-
ications classified as antianxiety (benzodiazepine, buspirone, or other)
or antidepressant (selective serotonin reuptake inhibitor, nonselective
serotonin reuptake inhibitor, tricyclic antidepressant, or other).
Data Collection. Masters-level independent evaluators unaware
of treatment assignment administered all outcome measures via tele-
phone at baseline and 6 months, supervised by the seventh author
(JAC), who provided training, conducted regular calibration meet-
ings, and reviewed a random 10% of audiotaped assessments. Interrater
agreement was excellent (intraclass correlation coefficients: SIGH-A =
.92; GADSS = 87).
393
Intervention. Five BLPs (all women, mean age = 25.6 years,
SD = 3.58), without previous mental health training or experience in
late-life anxiety, and five PLPs (all women, mean age = 30.8 years,
SD = 3.35), postdoctoral fellows with formal training and experience
in CBT for late-life anxiety, conducted CBT. BLPs were selected based
on their interest in participating in the project, with the goal of learn-
ing to deliver skills-based treatment to older adults and with a bach-
elor’s degree in a relevant field (e.g., psychology, sociology, etc.). An
experienced program manager (P. D. Wagener) and the first author
(M. A. Stanley) conducted interviews to assess interpersonal and com-
munication skills. A Wilcoxon Mann–Whitney (MW) test indicated
no significant difference in age between the two provider groups, x =
−1.89, P = .06. All providers were unlicensed and supervised by senior
experts in late-life anxiety (BLP: CKS; PLP: MAS).
BLPs worked on the project for 1 or 2 years each, and PLPs worked
on the project for 1–3 years. Prior to joining the project, PLPs aver-
aged 1.3 years’ (SD = 0.45 years) experience in CBT for late-life GAD
in the first author’s research group and 3.8 years’ (SD = 2.59 years)
of additional experience in CBT during graduate training. Training
for BLPs included reading and didactics (11 hr), review of audiotaped
sessions conducted by experts (20 hr), and role plays of all skills (5 hr).
Supervision included audiotape review and feedback for two nonstudy
patients followed by weekly group supervision meetings. PLP train-
ing addressed program procedures (5.5 hr), and supervision occurred
weekly in a group format. Average amount of supervision time per
week did not differ across groups (BLP = 0.52 hr, SD = 0.08; PLP =
0.40 hr, SD = 0.14, Wilcoxon MW z = 1.25, P = .21.
CBT occurred over 6 months. During the first 3 months, patients
received up to 10 skill-based sessions, including core (education, aware-
ness training, and motivational interviewing; deep breathing; coping
self-statements) and elective skills (behavioral activation, exposure,
sleep management, problem solving, progressive muscle relaxation,
thought stopping and cognitive restructuring) skills. Providers rec-
ommended skill modules based on an algorithm.[67] However, in an
effort to mirror real-world care and person-centered approaches where
patients make choices about which treatment recommendations to fol-
low, after discussion of recommended skills, patient preference deter-
mined which modules to include. Sessions 1 and 2 were in person. Sub-
sequent sessions occurred either in person or by telephone, depending
on patient preference. Workbook pages with information summaries
and practice exercises were provided during in-person sessions or via
mail before telephone meetings. Clinicians contacted patients to re-
view skills and answer questions 2–3 days after each skill-training ses-
sion. During the second 3 months, patients were called weekly for
4 weeks and then biweekly for 8 weeks to review skills and provide
support for continued practice and skills use.
Sessions were audiotaped, and a random 20% were rated by two
independent treatment integrity raters, who coauthored the original
treatment manual that was the basis for the CBT.[68] Neither partic-
ipated in any other way during this study. Mean ratings of adherence
and competence were above 6 (good adherence/competence) in both
BLP and PLP groups, on a scale from 0 (no adherence/competence)
to 8 (optimal adherence/competence). However, mean ratings were
significantly higher for PLPs than BLPs (adherence: PLPs = 7.66,
SD = 0.60; BLPs = 7.32, SD = 0.68; t(136) = 3.06, P = .003; com-
petence: PLPs = 7.12, SD = 0.83; BLPs = 6.60, SD = 0.91; t(136) =
3.55, P < .001).
Patients receiving CBT completed an average of 7.31 sessions
(SD = 2.65), with 57% (M = 0.57, SD = 0.37) of sessions three through
10 conducted by telephone. Average number of sessions did not differ
significantly between BLP (7.05, SD = 2.88) and PLP (7.58, SD =
2.39) groups, t(148) = 1.22, P = .22), and the proportion of telephone
sessions was not significantly different in BLP (M = 0.51, SD = 0.40
and PLP (M = 0.63, SD = 0.34%) groups, t(137) = 1.79, P = .08.
Depression and Anxiety
394 Stanley et al.
Mean number of practice exercises per week also was equivalent across
BLP and PLP groups (BLP: 2.28, SD = 1.21; PLP: 2.51, SD = 1.26;
t(145) = 1.16, P = .25).
Communication with the PCP occurred via the EMR. Initial notes
indicated diagnoses assigned and inclusion/exclusion status. For ex-
cluded patients, potential referrals were provided to the PCP. For all
patients randomized, diagnostic information was provided to PCPs,
who were encouraged to continue providing care as usual. For pa-
tients assigned to CBT, subsequent notes after each session described
treatment procedures; but nothing about provider background (BLP,
PLP).
DATA ANALYSIS
On the basis of prior results,[39] we predicted small-to-moderate ef-
fect sizes for primary outcomes (PSWQ-A, GADSS, STAI-T, SIGH-
A). Power calculations revealed that 156 participants (52 per treatment
condition) would be required to detect such effect sizes in either CBT
group relative to UC, with a two-tailed α of .05 and power of .80.
Allowing for 30% attrition, target enrollment was 74 participants per
group (total N = 222). The total sample (N = 223; BLP: 76, PLP: 74,
UC: 73) meets these requirements.
Study dropouts were those who failed to complete 6-month assess-
ment. We compared patients who dropped with those who did not on
pretreatment demographic variables, baseline clinical characteristics,
and medication use with independent samples t-tests and chi-square
analyses. Other pretreatment analyses compared treatment groups on
demographic variables, baseline clinical characteristics, and medication
use with between-groups one-way analyses of variance and chi-square
analyses. In the event that any variables differed by either attrition or
treatment group, those variables would be included as covariates in
subsequent analyses.
Outcome analyses examined differences between treatment groups
in primary and secondary outcomes at 6 months, with pretreatment
assessment and clinic site (MEDVAMC, BCM) as covariates, as well
as any variables differing by attrition status or treatment group. Ini-
tial analyses included all observations and used intent-to-treat (ITT)
methods with multiple imputation procedures (Proc MI and Proc MI-
ANALYZE, SAS Version 9.3) to address missing data. Homogeneity
of variance was examined across treatment groups with the Brown
Forsyth test, using Welch’s correction when this assumption was vio-
lated. To control for multiple comparisons, clusters of outcomes (i.e.,
worry, anxiety, health-related quality of life), each containing two mea-
sures, were evaluated with critical α of P ≤ .025. Outcomes containing
only one measure (depression, insomnia) were evaluated with α of
.05. All significance tests were two-sided. Significant main effects of
treatment were followed with pairwise comparisons between all three
groups, adjusted using Bonferroni correction to prevent α inflation,
with critical α of P < 017.
Analyses were repeated for study completers, using between-group
analysis of covariance (ANCOVA) with correction for multiple com-
parisons within clusters of outcomes (i.e., worry, anxiety, health-related
quality of life). Significant treatment effects were followed with pair-
wise comparisons using adjusted α of P ≤ .017.
For antianxiety and antidepressant medications separately, two chi-
square tests were used to examine associations between change in med-
ication over 6 months and treatment group. Changes were classified as:
(1) increasing dosage or adding a medication or (2) decreasing dosage
or discontinuing a medication.
As in prior trials of CBT for GAD,[51, 58, 69] treatment response was
defined by a 20% reduction at 6 months in at least three of the four
primary outcomes: (1) PSWQ-A; (2) GADSS; (3) STAI-T; and (4)
SIGH-A. This measure is more comprehensive than other valid re-
sponse methods (e.g., reliable change index, minimal clinically signifi-
cant difference), but demonstrates agreement with other methods.[70]
Depression and Anxiety
Treatment-group differences in proportions of treatment responders
at 6 months were compared in ITT and completer samples, using chi-
square analyses. For ITT analyses, patients with missing data were
classified as nonresponders.
RESULTS
SAMPLE SELECTION AND STUDY ATTRITION
See Fig. 1 for results of recruitment and number com-
pleting assessment and randomization. Randomized in-
dividuals (N = 223) were more educated (M = 15.52
years, SD = 2.92) than those who provided consent
but were not randomized (N = 336; M = 14.41, SD =
2.91, t(553) = −4.38, P < .0001). Randomized patients
also were less likely to be men (46.64% (104/223)),
more likely to be White (78.92% (176/223)), and had
higher income (26.85% (58/216) reporting >$60k) than
nonrandomized individuals (71.04% (238/335) men;
60.96% (203/333) White; 18.75% (60/320) > $60k),
(χ 2 (1) = 33.62, P < .0001, χ 2 (1) = 19.86, P < .0001,
and χ 2 (6) = 13.45, P = .04, respectively).
Of 223 randomized patients, 43 (19.3%) dropped out
(lacked 61-month data). Study dropout rates were sig-
nificantly different across treatment groups (χ 2 (2) =
14.64, P = .001), with higher rates in both BLP and
PLP groups relative to UC (BLP: 31.6%; PLP: 18.9%;
UC: 6.85%). Although study dropout rate was higher in
BLP than PLP, the difference was not statistically signif-
icant (χ 2 (1) = 3.18, P = .07). Study dropouts had lower
pretreatment SIGH-A scores than those completing the
study (M = 16.9, SD = 9.36 and M = 20.5, SD = 9.38,
respectively, t(221) = 2.20 P = .029). Analyses of pri-
mary and secondary outcomes included both site and
pretreatment SIGH-A as covariates.
SAMPLE CHARACTERISTICS AND
PRETREATMENT COMPARISONS
Sample characteristics are included in Table 1. Groups
did not differ significantly on any baseline measures.
Primary Analyses. Mean observed scores at 0 and
6 months are presented in Table 2. Imputed means were
not statistically or substantially different from observed
values.
Primary Outcomes. After we controlled for α in-
flation due to multiple comparisons, ITT analyses in-
dicated main effects of treatment group at 6 months
on the GADSS (F(2, 217) = 4.84, P = .008), STAI-T
(F(2, 217) = 5.17, P = .006), and SIGH-A (F(2, 218) =
4.58, P = .010). Pairwise comparisons indicated no dif-
ferences between GADSS, STAI-T, and SIGH-A scores
for patients treated by BLPs and PLPs, but there was sig-
nificantly greater improvement on all measures among
patients receiving CBT from BLPs or PLPs relative to
those receiving UC (see Table 3). There was no effect
of treatment at 6 months on the PSWQ-A. Completer
analyses resulted in the same pattern of statistical results.
Secondary Outcomes. ITT analyses indicated sig-
nificant main effects of treatment group at 6 months on
 Research Article: Lay Provider Delivery of CBT for GAD: An RCT 395

Figure 1. Flow of patients through each phase of the study, ax = assessment.

the PHQ-8 (F(2, 217) = 5.11, P = .006)), ISI (F(2,217) =
4.92, P = .007) and MCS (F(2, 217) = 6.53, P = .002).
Pairwise comparisons indicated significantly greater
improvement on the PHQ-8, ISI, and MCS among pa-
tients in the BLP and PLP groups relative to UC but no
differences between the two CBT groups (see Table 3).
There was no effect of treatment at 6 months on the
PCS. Completer analyses resulted in the same pattern
of statistical results, except that greater improvement on
the MCS occurred only among patients receiving CBT
from PLPs relative to those receiving UC.
Psychotropic Medication Use. Patients did not
increase doses or add antianxiety medication at differ-
ent rates over 6 months (BLP: 20.0%; PLP: 26.7%; UC:
53.3%; χ 2 (2) = 2.22, P = .33). Similarly, patients did
not increase doses or add antidepressant medication at
different rates over 6 months (BLP: 21.6%; PLP: 35.1%;
UC: 43.2%; χ 2 (2) = 2.12, P = .35). Rates of decreasing
doses or discontinuation of medications also were equiv-
alent over 6 months for both antianxiety (BLP: 18.8%;
PLP: 31.3%; UC: 50.0%, χ 2 (2) = 1.85, P = .40) and

Depression and Anxiety

396 Stanley et al.

TABLE 1. Baseline sociodemographic and clinical characteristics by treatment group

Treatment group
Overall (N = 223) PLP (n = 74) BLP (n = 76) UC (n = 73) P-value*

Age, mean (SD) 66.92 (6.64) 67.53 (6.47) 66.07 (6.25) 67.21 (7.17) .37
Education, mean (SD; n = 222) 15.52 (2.92) 15.40 (3.15) 15.51 (3.09) 15.64 (2.51) .88
Women (n, %) 119 (53.36) 41 (55.41) 34 (44.74) 44 (60.27) .15
Race, n (%)
White 176 (78.92) 59 (79.73) 61 (80.26) 56 (76.71) .85
Black 40 (17.94) 12 (16.22) 12 (15.79) 16 (21.92)
Asian 3 (1.35) 1 (1.35) 2 (2.63) 0 (.00)
American Indian/Alaskan native 1 (.45) 0 (.00) 1 (1.32) 0 (.00)
Multiracial 3 (1.35) 2 (2.70) 0 (.00) 1 (1.37)
Hispanic/Latino (n, %) 24 (10.76) 8 (10.81) 8 (10.53) 8 (10.96) 1.00
Marital , n (%)
Married or cohabiting 121 (54.26) 34 (45.95) 45 (59.21) 42 (57.53) .21
Widowed 33 (14.80) 9 (12.16) 9 (11.84) 15 (20.55)
Separated/divorced 60 (26.90) 27 (36.49) 18 (23.68) 15 (20.55)
Never married 9 (4.04) 4 (5.41) 4 (5.26) 1 (1.37)
Income, n (%; n = 216)
< 10k 21 (9.72) 10 (13.89) 7 (9.59) 4 (5.63) .49
10k–20k 26 (12.04) 7 (9.72) 8 (10.96) 11 (15.49)
20k–30k 32 (14.81) 13 (18.06) 11 (15.07) 8 (11.27)
30k–40k 31 (14.35) 11 (15.28) 10 (13.70) 10 (14.08)
40k–50k 24 (11.11) 7 (9.72) 11 (15.07) 6 (8.45)
50k–60k 24 (11.11) 4 (5.56) 11 (15.07) 9 (12.68)
>60k 58 (26.85) 20 (27.78) 15 (20.55) 23 (32.39)
Employment status, n (%)
Employed full- or part-time 79 (35.42) 25 (33.78) 33 (43.42) 21 (28.77) .13
Homemaker 6 (2.69) 2 (2.70) 3 (3.95) 1 (1.37)
Retired 116 (52.02) 39 (52.70) 34 (44.74) 43 (58.90)
Unemployed 22 (9.87) 8 (10.81) 6 (7.89) 8 (10.96)
BCM (n, %) 122 (54.71) 41 (55.41) 42 (55.26) 39 (53.42) .96
Assessment scores, mean (SD)
GADSS 11.74 (4.31) 11.70 (3.88) 11.61 (4.70) 11.92 (4.36) .90
PSWQ-A 24.66 (7.72) 24.36 (7.34) 24.58 (8.54) 25.05 (7.28) .86
STAI-T 47.10 (9.84) 46.68 (9.12) 47.09 (11.20) 47.53 (9.11) .85
SIGH-A 19.81 (9.45) 19.77 (8.46) 18.75 (10.09) 20.95 (9.72) .37
PHQ-8 9.87 (5.50) 9.88 (5.66) 9.72 (5.46) 10.00 (5.45) .95
SF-12 MCS 42.30 (9.98) 43.30 (10.40) 42.30 (9.68) 41.30 (9.88) .48
SF-12 PCS 42.03 (12.15) 41.11 (12.26) 44.00 (12.78) 40.89 (11.24) .22
ISI 11.60 (7.03) 11.34 (7.27) 11.58 (7.05) 11.89 (6.83) .89
Presence of coexistent diagnosis, n (%)
Any other diagnosis (n, %) 130 (58.30) 45 (60.81) 39 (51.32) 46 (63.01) .30
Any other anxiety (n, %) 90 (40.36) 33 (44.59) 26 (34.21) 31 (42.47) .39
Any depression (n, %) 86 (38.57) 24 (32.43) 30 (39.47) 32 (43.84) .36
Psychotropic medications
Any psychotropic medications (n, %) 145 (65.02) 51 (68.92) 53 (69.74) 41 (56.16) .15
Antianxiety medications (n, %) 26 (11.66) 8 (10.81) 10 (13.16) 8 (10.96) .88
Antidepressants (n, %) 122 (54.71) 43 (58.11) 47 (61.84) 32 (43.84) .07
Sleep aid medications (n, %) 39 (17.49) 15 (20.27) 9 (11.84) 15 (20.55) .28

Note: Race comparison is White versus non-White; marital status comparison is married/cohabiting versus not married/cohabiting; employment
status comparison is employed (FT or PT) versus not employed (six homemakers not included in analysis). As for race, participants were given
categories and self-reported their race. In addition to the categories in Table 1, participants also had the option to select Hawaiian or Islander
(which no one selected) or “Other” (which none of the randomized participants selected but 11 of the consented but nonrandomized participants
selected.
*For overall comparison between the three intervention arms, using analysis of variance or chi-square tests.
PLP, Ph.D.-level providers; BLP, bachelor-level providers; UC, usual care; BCM, Baylor College of Medicine; GADSS, Generalized Anxiety
Disorder Severity Scale; PSWQ-A, Penn State Worry Questionnaire-Abbreviated; STAI-T, Trait subscale of the Spielberger State-Trait Anxiety
Inventory; SIGH-A, Structured Interview Guide for the Hamilton Anxiety Scale; PHQ-8, 8-Item Patient Health Questionnaire; SF-12 MCS,
Mental Component Scores of the Medical Outcomes Study Short Form; SF-12 PCS, Physical Component Scores of the Medical Outcomes Study
Short Form; ISI, Insomnia Severity Index.

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 TABLE 2. Observed means on primary and secondary outcomes

Treatment Observed means by time point BL SIGH-A BL covariate Site Treatment condition
group Baseline (n = 223) 6-month (n = 180) F P η2 F P η2 F P η2 F P η2

PSWQ-A PLP 24.36 (7.34) 19.58 (7.53) 5.66 .017 .018 69.22 <.0001 .227 3.17 .074 .009 2.29 .101 .010
BLP 24.58 (8.54) 20.92 (8.68)
UC 25.05 (7.28) 22.81 (7.57)
SIGH-A PLP 19.77 (8.46) 15.25 (10.03) – – – 75.69 <.0001 .260 6.71 .010 .018 4.58 .010 .023
BLP 18.75 (10.09) 14.58 (10.14)
UC 20.95 (9.72) 19.94 (10.42)
STAI-T PLP 46.68 (9.12) 39.70 (10.22) .64 .425 .002 90.25 <.0001 .037 3.39 .065 .009 5.17 .006 .023
BLP 47.09 (11.20) 42.13 (11.20)
UC 47.53 (9.11) 45.39 (10.84)
GADSS PLP 11.70 (3.88) 8.78 (4.16) 5.38 .020 .024 8.76 .003 .037 .08 .780 .001 4.84 .008 .031
BLP 11.61 (4.70) 9.15 (4.63)
UC 11.92 (4.36) 11.21 (4.63)
PHQ-8 PLP 9.88 (5.66) 6.18 (5.77) 2.59 .108 .011 31.14 <.0001 .106 .20 .655 .001 5.11 .006 .027
BLP 9.72 (5.46) 6.75 (5.57)
UC 10.00 (5.45) 9.18 (6.04)
ISI PLP 11.34 (7.27) 7.88 (7.06) 6.81 .009 .024 29.16 <.0001 .011 .92 .337 .005 4.92 .007 .029
BLP 11.58 (7.05) 7.98 (6.99)
UC 11.89 (6.83) 11.57 (7.04)
PCS PLP 41.11 (12.26) 41.66 (11.91) 3.42 .065 .009 158.76 <.0001 .391 1.61 .203 .005 1.75 .173 .003
BLP 44.00 (12.78) 45.17 (12.38)
UC 40.89 (11.24) 40.97 (11.98)
MCS PLP 43.30 (10.40) 49.85 (10.26) .10 .759 .001 45.16 <.0001 .150 5.38 .021 .019 6.53 .002 .034
BLP 42.30 (9.68) 46.77 (10.81)
Research Article: Lay Provider Delivery of CBT for GAD: An RCT

UC 41.30 (9.88) 42.98 (10.13)

Note: Two individuals (1 PLP and 1 UC) were missing the PCS, MCS, and ISI at 6 months but are included in all other observed means.

Depression and Anxiety

397
398 Stanley et al.

TABLE 3. Pairwise comparisons to follow-up significant main effects of treatment

PLP vs. UC BLP vs. UC PLP vs. BLP

t P g t P g t P g

GADSS − 3.03 .003 .500 − 2.43 .016 .398 − .61 .543 .100
STAI-T − 2.91 .004 .480 − 2.82 .005 .462 − .16 .873 .026
SIGH-A − 2.44 .015 .403 − 2.60 .010 .426 .26 .798 .042
PHQ-8 − 3.17 .002 .523 − 2.41 .016 .395 − .75 .457 .122
ISI − 2.85 .005 .460 − 2.56 .011 .470 − .28 .781 .420
MCS 3.43 <.001 .566 2.79 .005 .457 .80 .425 .131

Note: The P values for the pairwise comparisons were evaluated at P < .0167, due to the Bonferroni adjustment. g represents Hedge’s g, a measure
of effect size.
PLP, Ph.D.-level providers; BLP, bachelor-level providers; UC, usual care; GADSS, Generalized Anxiety Disorder Severity Scale; STAI-T, Trait
subscale of the Spielberger State-Trait Anxiety Inventory; SIGH-A, Structured Interview Guide for the Hamilton Anxiety Scale; PHQ-8, 8-item
Patient Health Questionnaire; ISI, Insomnia Severity Index; MCS, Medical Composite Score of the 12-item Medical Outcomes Study Short Form.

antidepressant (BLP: 33.3%; PLP: 38.5%; UC: 28.2%;
χ 2 (2) = 1.34, P = .51) medications.
Treatment Response Rates. Percent of treatment
responders for both ITT and completer analyses are re-
ported in Table 4. Chi-square analyses indicated no sig-
nificant group differences in response rates at 6 months
according to ITT analyses; but a significant group dif-
ference occurred in response rates for patients complet-
ing 6-month assessments, with higher percentages of re-
sponders in BLP (40%) and PLP (38.5%) relative to UC
(19.1%).
DISCUSSION
Among older adult primary care patients with GAD,
outcomes were comparable when CBT was conducted
by BLPs and PLPs, with both groups showing sig-
nificantly improved GAD severity, anxiety, depressive
symptoms, insomnia, and mental health quality of life,
relative to UC. Response rates for those providing 6-
month data also were comparable for BLP and PLP. In
both treatment groups, completion response rates were
higher than those for UC and comparable to response
rates in prior studies of CBT for late-life GAD (40%,[39]
33%,[51] 45%[58] ). Although adherence and competence
ratings were lower for BLPs than PLPs, BLPs were ad-
herent and competent with treatment procedures; and
the average number of treatment sessions, proportion
of telephone sessions and average number of exercises
completed were comparable across the two groups.
These outcomes support the utility of lay providers
to deliver evidence-based mental health care, supervised
by a licensed provider, and are directly relevant to re-
cent IOM recommendations to develop a broader work-
force, supported sufficiently by specialty providers, to
reduce barriers to mental health care for older adults.[1]
The ability to train lay providers who can offer psy-
chosocial care with sufficient supervision and over-
sight increases potential access and reach of evidence-
based care.[71] This type of “disruptive innovation” in
mental healthcare delivery, along with recent advances
in technology-based interventions,[72–74] challenges
traditional ideas about service delivery but might bridge
the gap between evidence and practice that plagues cur-
rent care models.[75]
Study attrition overall (19%) and within the PLP
group (19%) was lower than psychotherapy studies for
late-life anxiety often report (21–39%),[28] suggesting
the potential benefit of a personalized approach to treat-
ment. Study attrition in BLP was higher (32%) but still
within the range of prior studies and not significantly
different from PLP. Moreover, patients in both groups
attended equivalent numbers of sessions, suggesting
comparable engagement in treatment.
Significant strengths of this study include provider-
training procedures that produced good adherence
and competence among lay providers with no prior

TABLE 4. Treatment response rates at 6 months

N (%)
PLP BLP UC χ2 P

ITT 24/74 (32.4) 20/76 (34.1) 13/73 (17.8) 4.17 .125

Completer 24/60 (40.0) 20/52 (38.5) 13/68 (19.1) 7.98 .019

Note: Figures indicate the number (percentage) of individuals with a reduction of 20% in three of four primary outcomes (PSWQ-A; GADSS;
STAI-T; SIGH-A). For ITT analyses, nonresponders included patients without 6-month assessment data.
PLP, Ph.D.-level providers; BLP, bachelor-level providers; UC, usual care; ITT, intent to treat.

Depression and Anxiety

 Research Article: Lay Provider Delivery of CBT for GAD: An RCT
healthcare experience and positive treatment outcomes
for both BLP and PLP groups, using a treatment model
with flexibility in content and delivery options. Gener-
alizability of study findings is limited, however, because
randomized patients were better educated, more likely
to be women and White, and had higher income than
most samples. The lack of treatment findings on the
PSWQ-A is notable, given the consistency with which
the full PSWQ has demonstrated change following CBT
for late-life GAD.[36, 39, 51, 58] Finally, interrater agree-
ment for diagnosing GAD was not as high as for other
disorders, but the kappa coefficient here is in line with
prior work documenting weaker agreement for GAD
than other anxiety disorders, likely given the absence of
clear behavioral markers.[76]
This study paves the way for future effectiveness and
implementation trials of CBT for late-life GAD in other
practice settings, including community-based social ser-
vice agencies in which a range of providers could learn to
deliver CBT. Key implementation issues include defin-
ing the system requirements and costs for two key
components of this anxiety-treatment approach: (1)
preparation of effective providers and (2) adequate spe-
cialty supervision and consultation. This information is
needed to help modify current funding methods (e.g.,
Medicare, Medicaid, other public social service payers)
to reimburse new models that expand reach, using non-
expert providers supervised by specialty consultants in
primary care and other service settings.1,2
Acknowledgments. This research was supported
by a grant from the National Institute of Mental Health
(NIMH; R01-MH53932) to the first author and by the
Houston VA HSR&D Center for Innovations in Qual-
ity, Effectiveness and Safety (CIN-13-413)). The au-
thors would like to thank Gretchen Diefenbach, Ph.D.,
Hartford Institute of Living, and Derek Hopko, Ph.D.,
University of Tennessee–Knoxville, who provided rat-
ings of treatment integrity; and Bruce Rollman, M.D.,
University of Pittsburgh, and Diane Novy, Ph.D., The
University of Texas M. D. Anderson Cancer Center,
who served as consultants for this study. These indi-
viduals received financial compensation from the grants
for their contributions. The authors also appreciate the
input of three anonymous reviewers, who received no
compensation.
The content is solely the responsibility of the authors
and does not necessarily represent the official views of
1 Participants were asked to self-identify race and ethnicity, accord-
ing to these categories: white, black, Asian, American Indian/Alaskan
Native, Hawaiian or Islander, multiracial, or other; Hispanic or non-
Hispanic.
2 Principal diagnosis was the disorder with the highest severity rating;
2 equally severe diagnoses resulted in assignment of coprincipal di-
agnoses; and coexistent anxiety, affective, and somatization disorders
were allowed.
399
the NIMH, the National Institutes of Health, or the
Veterans Administration, the US government or Baylor
College of Medicine. The NIMH had no role in the de-
sign and conduct of the study; collection, management,
analysis, and interpretation of the data; and preparation,
review, or approval of the manuscript.
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