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

Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

we recruited patients.[43] We placed educa- enced in health care to deliver anxiety or depression tional brochures in waiting and examination rooms to facilitate patient care for older adults under the supervision of licensed self-referral and used the electronic medical record (EMR) to iden- providers and compared outcomes with those achieved tify other potential participants.76). UC: 19.[36–39] Despite positive to-excellent agreement for GAD (. whose symptoms met diagnostic criteria for principal cial workers.91). 10] and clinical trials[8.69). (MEDVAMC) approved the study.[4–6] but limited data address Institutional review boards at Baylor College of Medicine (BCM) their role in delivering mental health interventions. Included par- pression delivered by experts and nonexperts produce ticipants received $20 for each completed assessment. 40] In light of IOM recommendations. can deliver effective CBT. 2014.. the to the SCID. .[23] sleep disturbance. However.[12–14] or coprincipal GAD.[1. DeBakey Veterans Affairs Medical Center Recent literature reviews[9. 8] and the Michael E. These Recent Institute of Medicine (IOM) recommendations data extend findings from a pilot study that showed pos- include developing novel models of care to reduce bar. and a random 20% were rated by a second expert examining alternative delivery options (e. depression (major depression outcomes for these treatments.[41] providers. completers in BLP and PLP relative to UC (BLP: 38.[25–27] and increased service use. All SCID interviews were audiotaped and supervised older adults often receive mental health care. nosis of GAD or Anxiety Not Otherwise Specified. years and older. controlled clinical trial.[1] (PLPs) and usual care (UC). and PLP groups and improved relative to UC. Key words: psychotherapy. nosis of GAD of at least moderate severity (4 on 0–8 scale.[44] Those responding affirmatively to at least one Pharmacological and cognitive behavioral therapy question were scheduled for an in-person visit to review consent. some of which rely heavily on developing a included.1%). mental health INTRODUCTION providers (BLPs) without healthcare experience pro- T he growing number of older adults needing mental vided care under the supervision of experts and compared them with results of experienced Ph. commu- nity health workers. We then telephoned patients who with increased disability. riers and expand reach of mental health services for but sample size was small (n = 19).[22] did not call to decline participation to discuss the study. anxiety symptoms Anxiety disorders occur frequently among older adults in the problem list. all studies have used or dysthymia. modular to assess interrater agreement.S.[2. and geriatric clinics at MEDVAMC and BCM. although not necessarily as the first language. etc. GAD is associated (MAS) inviting them to participate. Patients identified by the EMR and approved by the PCPs particularly common (up to 7% )[15–18] and the focus received a letter from their PCP and the study principal investigator of most late-life anxiety research.) according able care.D. particularly among low-income. This article is a U.[15.[42] through internal medicine. PARTICIPANTS pression have tested interventions delivered by trained From October 2008 to April 2012.[2] (2) ability to speak English. no study has trained lay providers inexperi.[26] screening questions.[1] At this meeting or a subsequent appointment. working under the supervision of licensed providers. in collaboration with primary care providers (PCPs). family practice. repeat (CBT) are both effective for late-life GAD. memory difficulties. nurses.[24] reduced Patients expressing interest were asked two PRIME-MD anxiety quality of life. experienced or highly trained anxiety specialists. Conclusion: Lay providers.5%. We expected that outcomes Current and future needs far surpass the available work.[7. METHOD underserved older adults. at 6 months (posttreatment) would be similar in the BLP force of providers trained in geriatric mental health care.g. and prescriptions for antianxiety or antidepressant (12–15%).[28–31] but the anxiety screener. Published 2014. Depression and Anxiety 31:391–401. and treatment integrity raters were not blind broader workforce including nontraditional healthcare to therapist experience. lay providers) are valuable for ex- panding access to care. Studies in late-life de. 16] Generalized anxiety disorder (GAD) is medication. and other anxiety disorders (. dures.g. comparable outcomes.[19–21] medical comorbidity. age 60 providers with varying levels of healthcare expertise (so. itive outcomes for care delivered by nonexpert providers. Government work and is in the public domain in the USA. participants provided written informed consent. 3] Nontraditional providers (e.0%. Criteria for participation included an EMR diag- by expert providers. and (3) current psychosocial or pharmacolog- current study examined outcomes following CBT for ical treatment allowed but psychotropic medication stable over the late-life GAD in primary care when bachelor-level lay prior month. severely Inclusion criteria were (1) principal or coprincipal DSM-IV diag- limiting implementation readiness and access to afford. no control group was this group. After description of study proce- gest that psychosocial treatments of anxiety and de. PLP: 40. and by by the first author. and complete a demographic questionnaire. clinical case managers.392 Stanley et al. 11] sug. with potential economic and lo- gistic advantages for nonexperts. the six-item Cogni- many older people prefer psychosocial treatment.-level providers health care is expected to reach 10–14 million by 2030. telephone delivery).[32–35] tive Screener[45] and the Structured Clinical Interview for DSM-IV Recent studies have focused on broadening reach by Disorders (SCID)[46] were administered by Master’s level expert in testing CBT for GAD in primary care settings.). Kappa coefficients indicated adequate- treatment.. Exclusion criteria included presence of conditions that Depression and Anxiety . where late-life anxiety.2.

Providers rec- STAI-T is a 20-item self-report measure of general anxiety. Clinicians contacted patients to re- and the two versions of the scale highly correlated.22.58).8 years. and practice exercises were provided during in-person sessions or via metric properties of the PHQ-9 are strong among older adults. and PLPs worked ment (χ 2 (2) = 6. P = . patient preference deter- with demonstrated sensitivity to change in clinical trials.[56] The thought stopping and cognitive restructuring) skills. severity was evaluated with the Generalized Anxiety Disorder Severity CBT occurred over 6 months.22).40 hr.89.003.[45] SD = 3. Self-reported worry ing addressed program procedures (5. P = . Of particular interest were med. sion. However.37) of sessions three through phone at baseline and 6 months.12. and supervision occurred severity was measured with the PSWQ-A. 51] Clinician-rated worry/GAD 0. 39. PLP = clinical trials of late-life GAD.34%) groups.65).[61] mail before telephone meetings.32. The study experienced program manager (P. Depression and Anxiety . and motivational interviewing.[53. ications classified as antianxiety (benzodiazepine. SD = 0.08. 54] ness training. To mitigate this. Five BLPs (all women. etc. berger State-Trait Anxiety Inventory (STAI-T)[55] and the Structured sleep management. D. Wagener) and the first author statistician (HMR) generated a stratified randomization scheme using (M.88) and PLP (7. with more patients with high PSWQ-A on the project for 1–3 years. MEASURES AND DATA COLLECTION Supervision included audiotape review and feedback for two nonstudy Primary Outcomes. and reviewed a random 10% of audiotaped assessments.[59] low. Psycho. BLPs = 6.14. with the goal of learn- ing to deliver skills-based treatment to older adults and with a bach- Within each study site.68. coping Anxiety severity was assessed with the trait subscale of the Spiel. exposure. deep breathing. 58] The SIGH-A is a clinician-rated measure patients make choices about which treatment recommendations to fol- developed to increase reliability of the Hamilton Anxiety Scale. Depressive symptoms were assessed with sequent sessions occurred either in person or by telephone. depending the Patient Health Questionnaire-8 (PHQ-8).31 sessions of treatment assignment administered all outcome measures via tele. GADSS = 87).55. 31%) and UC aged 1. including core (education.51. and the proportion of telephone agreement was excellent (intraclass correlation coefficients: SIGH-A = sessions was not significantly different in BLP (M = 0.59 years) treatment with additional stratification based on baseline PSWQ-A of additional experience in CBT during graduate training.39) groups. An to a 1:1:1 ratio within blocks of nine to BLP. PLP. supervised by the seventh author 10 conducted by telephone. During the second 3 months. P = . Masters-level independent evaluators unaware Patients receiving CBT completed an average of 7.[36] Physical/mental health quality of life was measured with Sessions were audiotaped. who provided training. who coauthored the original two summary scores. progressive muscle relaxation. 42%) than PLP (25/81. mean age = 30. or other) SD = 0. substance abuse within the SD = 3. mean age = 25.60. Average amount of supervision time per ment derived from the original 16-item PSWQ. and five PLPs (all women. defined as three or more missed late-life anxiety.63. t(136) = serotonin reuptake inhibitor. patients were called weekly for self-report measure based on DSM-IV criteria for insomnia. The ISI 4 weeks and then biweekly for 8 weeks to review skills and provide has good concurrent validity[62] and is sensitive to change following support for continued practice and skills use. and role plays of all skills (5 hr).[63] which produces independent treatment integrity raters.45 years) experience in CBT for late-life GAD (22/81.21.[48–50] used widely in week did not differ across groups (BLP = 0. mean ratings were assessed psychotropic medication use. buspirone. P = .52 hr. t(137) = 1. mental (MCS) and physical (PCS).039). sociology. Average number of sessions did not differ (JAC).58. aware- has adequate psychometric properties among older adults. Prior to joining the project. or other). Research Article: Lay Provider Delivery of CBT for GAD: An RCT 393 threatened patient safety or precluded participation: active suicidal in.[62] a seven-item. Primary outcomes included self-report and patients followed by weekly group supervision meetings. Wilcoxon MW z = 1.[36. com- or antidepressant (selective serotonin reuptake inhibitor.6 years. and a random 20% were rated by two the 12-item Medical Outcomes Study Short Form.91. Workbook pages with information summaries sion of the PHQ-9[61] that omits the item assessing suicide. with 57% (M = 0.06. on patient preference. P = . SD = 0. postdoctoral fellows with formal training and experience in CBT for late-life anxiety. All providers were unlicensed and supervised by senior vealed a significant association between baseline Penn State Worry experts in late-life anxiety (BLP: CKS. PLPs aver- scores (≥26) in BLP (34/81. A Wilcoxon Mann–Whitney (MW) test indicated the study manager assigned the participant to a treatment condition.[36] mined which modules to include. without previous mental health training or experience in past month. munication skills.92. BLPs = 7. 3. A. SD = 0.40 . SD = 0. after discussion of recommended skills. conducted regular calibration meet. self-statements) and elective skills (behavioral activation.06. Mean ratings of adherence sensitive to change following treatment.[65] with the MCS ipated in any other way during this study. SD = 0. 27%).25.g. PLP train- clinician-rated measures of worry and anxiety. tricyclic antidepressant. Training score (cut score = 26). Sessions 1 and 2 were in person.05.08. significantly between BLP (7. problem solving.60. Data Collection.79. items on the six-item Cognitive Screener.[46. or UC. patients were randomly assigned according elor’s degree in a relevant field (e. t(136) = 3. remaining patients were assigned to in the first author’s research group and 3.57. conducted CBT. nonselective petence: PLPs = 7. significantly higher for PLPs than BLPs (adherence: PLPs = 7. weekly in a group format. SD = ings.83. SD = 2.[60] an eight-item ver.001). SD = 0. Sub- Secondary Outcomes. P = . Self-report questions about BLP and PLP groups. BLPs were selected based RANDOMIZATION on their interest in participating in the project. During the first 3 months. Stanley) conducted interviews to assess interpersonal and com- a random number generator.66. SD = 0. x = An interim randomization check (n = 169 baselines completed) re- −1. psychology.[64] Reliability treatment manual that was the basis for the CBT. current psychosis or bipolar disorder.3 years’ (SD = 0.[67] However. PLP: MAS). for BLPs included reading and didactics (11 hr).8 years’ (SD = 2. tent. Intervention.. patients Scale (GADSS). in an monly among older adults[57] and demonstrating sensitivity to change effort to mirror real-world care and person-centered approaches where following treatment. treatment.47. used com. ommended skill modules based on an algorithm. Interview Guide for the Hamilton Anxiety Scale (SIGH-A). P < .[52] a six-item scale that assesses DSM-IV criteria and received up to 10 skill-based sessions.[39] and competence were above 6 (good adherence/competence) in both Psychotropic Medication Use. no significant difference in age between the two provider groups. (SD = 2. t(148) = 1.5 hr). Upon completion of baseline assessment. 47] an eight-item instru.[36. Interrater 2.[60] Insomnia was view skills and answer questions 2–3 days after each skill-training ses- evaluated with the Insomnia Severity Index (ISI). Questionnaire Abbreviated (PSWQ-A) scores and treatment assign- BLPs worked on the project for 1 or 2 years each. and cognitive impairment.[68] Neither partic- and validity have been demonstrated in older adults.). SD = 0. and PLP (M = 0. on a scale from 0 (no adherence/competence) type and frequency of medications used over the prior 3 months[66] to 8 (optimal adherence/competence).35). review of audiotaped sessions conducted by experts (20 hr).

9%. icant (χ 2 (1) = 3. SD = 1. pretreatment SIGH-A as covariates.394 Stanley et al. Pairwise comparisons indicated no dif- square tests were used to examine associations between change in med. Randomized in- dividuals (N = 223) were more educated (M = 15.6%. as well study (M = 16. group (total N = 222).05 and power of .41.64. BLP: 76. Imputed means were treatment were followed with pairwise comparisons between all three not statistically or substantially different from observed groups.84. but were not randomized (N = 336. potential referrals were provided to the PCP.008). P < . target enrollment was 74 participants per nonrandomized individuals (71. were evaluated with critical α of P ≤ . Ini.38.025.3) to address missing data.51. ferences between GADSS. diagnostic information was provided to PCPs. adjusted using Bonferroni correction to prevent α inflation. STAI-T. Sample characteristics are included in Table 1. higher income (26. SD = 9.18. 69] treatment response was patients receiving CBT from BLPs or PLPs relative to defined by a 20% reduction at 6 months in at least three of the four those receiving UC (see Table 3). P < . 43 (19. The total sample (N = 223. 217) = 5. 18. health-related dicated main effects of treatment group at 6 months quality of life).85% (58/216) reporting >$60k) than Allowing for 30% attrition. As in prior trials of CBT for GAD. For all patients randomized. (2) GADSS. Analyses of pri- tial analyses included all observations and used intent-to-treat (ITT) mary and secondary outcomes included both site and methods with multiple imputation procedures (Proc MI and Proc MI. PLP: 18.91. analyses. SIGH.92% (176/223)). the difference was not statistically signif- subsequent analyses. t(553) = −4.[51. and SIGH-A (F(2. values. This measure is more comprehensive than other valid re.e.029). Significant main effects of 6 months are presented in Table 2. flation due to multiple comparisons. Power calculations revealed that 156 participants (52 per treatment also were less likely to be men (46. GADSS. P = . 218) = For antianxiety and antidepressant medications separately. Changes were classified as: for patients treated by BLPs and PLPs. on the GADSS (F(2. P = . RESULTS who were encouraged to continue providing care as usual.e.0001). To control for multiple comparisons. baseline clinical characteristics. SD = 1.006). anxiety. pretreatment demographic variables.17. 1 for results of recruitment and number com- PLP). Mean number of practice exercises per week also was equivalent across Treatment-group differences in proportions of treatment responders BLP and PLP groups (BLP: 2. and SIGH-A scores ication over 6 months and treatment group. All significance tests were two-sided. PRETREATMENT COMPARISONS worry.0001. Other pretreatment analyses compared treatment groups on nificantly different across treatment groups (χ 2 (2) = demographic variables.04. SAS Version 9.5. with a two-tailed α of .85%).0001. We compared patients who dropped with those who did not on and χ 2 (6) = 13.017. BCM) as covariates.04% (238/335) men. Initial notes classified as nonresponders. respectively). as any variables differing by attrition status or treatment group.45. but there was sig- (1) increasing dosage or adding a medication or (2) decreasing dosage nificantly greater improvement on all measures among or discontinuing a medication. each containing two mea.16. worry. Randomized patients A).28.86. with pretreatment pretreatment SIGH-A scores than those completing the assessment and clinic site (MEDVAMC. See Fig.38. Completer SIGH-A. PLP: 74.21. using between-group Primary Outcomes. UC: 73) meets these requirements.26. with critical α of P < 017.3%) dropped out and medication use with independent samples t-tests and chi-square (lacked 61-month data).36 and M = 20. Although study dropout rate was higher in treatment group. ment. 58. using Welch’s correction when this assumption was vio- lated. indicated diagnoses assigned and inclusion/exclusion status. Secondary Outcomes. sponse methods (e. STAI-T wise comparisons using adjusted α of P ≤ . Significant treatment effects were followed with pair.75% (60/320) > $60k). ITT analyses indicated sig- cant difference). with higher rates in both BLP and use with between-groups one-way analyses of variance and chi-square PLP groups relative to UC (BLP: 31. subsequent notes after each session described SAMPLE SELECTION AND STUDY ATTRITION treatment procedures.g. patients with missing data were Communication with the PCP occurred via the EMR. 4.64% (104/223)). P = . t(221) = 2. Homogeneity of variance was examined across treatment groups with the Brown SAMPLE CHARACTERISTICS AND Forsyth test.05. Study dropout rates were sig- analyses. For ITT analyses. ANALYZE. analyses resulted in the same pattern of statistical results. but demonstrates agreement with other methods. health-related quality of life). clusters of outcomes (i. For ex- cluded patients. condition) would be required to detect such effect sizes in either CBT more likely to be White (78. minimal clinically signifi. (3) STAI-T. but nothing about provider background (BLP. insomnia) were evaluated with α of Primary Analyses. and had group relative to UC. P = . Outcomes containing did not differ significantly on any baseline measures. those variables would be included as covariates in BLP than PLP. P < . square analyses. 2. After we controlled for α in- analysis of covariance (ANCOVA) with correction for multiple com. 217) = 4. two chi. PLP: 2.96% (203/333) White.07). Study dropouts were those who failed to complete 6-month assess- (χ 2 (1) = 33. M = 14.001). P = . and (4) of treatment at 6 months on the PSWQ-A. SD = 2.[70] nificant main effects of treatment group at 6 months on Depression and Anxiety . SD = fect sizes for primary outcomes (PSWQ-A. pleting assessment and randomization. P = . STAI-T.25). anxiety. χ 2 (1) = 19. In the event that any variables differed by either attrition or UC: 6.92) than those who provided consent On the basis of prior results. baseline clinical characteristics. at 6 months were compared in ITT and completer samples. For pa- tients assigned to CBT.62. ITT analyses in- parisons within clusters of outcomes (i. Groups sures. respectively.. P = . There was no effect primary outcomes: (1) PSWQ-A.010)..58. Mean observed scores at 0 and . reliable change index.80. Study dropouts had lower Outcome analyses examined differences between treatment groups in primary and secondary outcomes at 6 months.[39] we predicted small-to-moderate ef.52 DATA ANALYSIS years. 60. SD = 9.. only one measure (depression.20 P = . using chi- t(145) = 1. Of 223 randomized patients. (F(2.9. and medication 14. Analyses were repeated for study completers.

8%.1%. Completer analyses resulted in the same pattern doses or discontinuation of medications also were equiv- of statistical results. χ 2 (2) = 2. UC: 50. ax = assessment. Patients did not 217) = 5. Depression and Anxiety . Research Article: Lay Provider Delivery of CBT for GAD: An RCT 395 Figure 1.3%. PLP: 26.11. and MCS among pa.7%. Flow of patients through each phase of the study. PLP: 35.40) and from PLPs relative to those receiving UC. different rates over 6 months (BLP: 21.85. except that greater improvement on alent over 6 months for both antianxiety (BLP: 18.2%. χ 2 (2) = 2.0%. P = . P = . 217) = 6.92. increase doses or add antianxiety medication at differ- Pairwise comparisons indicated significantly greater ent rates over 6 months (BLP: 20. P = . Similarly. Rates of decreasing PCS. patients did tients in the BLP and PLP groups relative to UC but no not increase doses or add antidepressant medication at differences between the two CBT groups (see Table 3). 53.35).53.007) and MCS (F(2. UC: improvement on the PHQ-8. χ 2 (2) = 1.0%. P = . There was no effect of treatment at 6 months on the UC: 43. the MCS occurred only among patients receiving CBT PLP: 31.6%.3%. the PHQ-8 (F(2. ISI.002). P = . P = .006)).217) = Psychotropic Medication Use. ISI (F(2.

92) 15.87) 8 (10.00) 1 (1.09) 15.47) 66.16) 8 (10.02) 39 (52. Generalized Anxiety Disorder Severity Scale.89) 8 (10.74) 43 (58. STAI-T.04) 4 (5.95 (9.63) 0 (.36) 33 (44.46) 10.34 (7.76) 8 (10.01) .21) 31 (42.00) Multiracial 3 (1. Structured Interview Guide for the Hamilton Anxiety Scale.41) 34 (44.66) 8 (10.37) Income.83) . Penn State Worry Questionnaire-Abbreviated. Insomnia Severity Index. BCM.16) .55) Never married 9 (4.30 Any other anxiety (n.60 (7.77) .78) 15 (20.92 (6.96) 11 (15.72) 11 (15.04) 7 (9. SIGH-A.08) 40k–50k 24 (11.74 (4.17) .11) 7 (9.49) 18 (23.56) 11 (15.21 (7. mean (SD.55) 23 (32. PHQ-8.25) 67.34) 24.45) 0 (.12) 47.09) 20.71) 41 (55.58 (7.46) 18.59) 26 (34. marital status comparison is married/cohabiting versus not married/cohabiting.00 Marital .51) .43) 30 (39.15) 41.81) 8 (10.21) 42 (57. In addition to the categories in Table 1.84) 32 (43.37) Retired 116 (52.27) 11. %) 26 (11.95) 45 (59.80) 9 (12. %) 39 (17. PLP.55) .40) 42.09 (11.90) 27 (36.84) 46.54) 25.87 (5.74) 44 (60.24) .39) Employment status.79) 16 (21.85) 20 (27. participants were given categories and self-reported their race.50) 9.81) 39 (51. UC.72) . n (%) White 176 (78.53) . n (%. Depression and Anxiety .07) 8 (11.55) Separated/divorced 60 (26.89 (11.88 Women (n.27) 30k–40k 31 (14.07 Sleep aid medications (n.89 (6.95 SF-12 MCS 42.84) .92) 53 (69.28 Note: Race comparison is White versus non-White.30) 45 (60.69) 2 (2.32) 0 (.66 (7.77 (8.30 (9. Physical Component Scores of the Medical Outcomes Study Short Form.00) 1 (1.70 (3.37 Education.30 (9. 8-Item Patient Health Questionnaire.45) 19.or part-time 79 (35. n = 222) 15.03) 11.89) 7 (9. GADSS. PSWQ-A.90 PSWQ-A 24.63) .03 (12. usual care.32) 46 (63.47) .78) 33 (43.15 Race.66) 9.96) .16) 9 (11.92) 59 (79.73) 61 (80.53) 8 (10.75 (10.35) 1 (1.22) 12 (15.72 (5.70) 3 (3.26) 1 (1.06) 11 (15.41) 42 (55. TABLE 1.68 (9.58 (8.02) 51 (68. n (%) Employed full.11 (12. employment status comparison is employed (FT or PT) versus not employed (six homemakers not included in analysis).49) 15 (20.35) 2 (2.59) 4 (5.88) 11.41) 4 (5. n (%) Any other diagnosis (n.42) 25 (33. Ph.10 (9.85 Black 40 (17.39 Any depression (n.94) 12 (16.37 PHQ-8 9. bachelor-level providers.26) 39 (53.98) 43.-level providers.D.84) 15 (20. SF-12 PCS.07) 9 (12.21 Widowed 33 (14. %) 122 (54.15) 15.396 Stanley et al.96) BCM (n.31) 11. n (%) Married or cohabiting 121 (54.42) .30 (10.72) 10 (13.71) 43 (58.00 (5.35) 2 (2.70) 0 (.84) .81) 10 (13.88 (5.57) 24 (32.68) >60k 58 (26.07 (6.53 (6.45) 50k–60k 24 (11.20) 47.36) .00) American Indian/Alaskan native 1 (.81 (9.07) 6 (8. SF-12 MCS.72) 8 (10.53 (9.92 (4.45) .36 Psychotropic medications Any psychotropic medications (n.51 (3.81) 6 (7.42) 21 (28.61 (4.92) Asian 3 (1.89 Presence of coexistent diagnosis. mean (SD) 66.70) 34 (44.26) 34 (45.37) Hispanic/Latino (n. mean (SD) GADSS 11. %) 130 (58.49 10k–20k 26 (12.00 (12.05 (7. Trait subscale of the Spielberger State-Trait Anxiety Inventory.90) Unemployed 22 (9. using analysis of variance or chi-square tests.88) .30 (9. %) 145 (65.28) .15 Antianxiety medications (n.05) 11.86 STAI-T 47.68) 15 (20. 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.27) .11) 47 (61.84) 15 (20. %) 24 (10.64) 67.81) 13 (18. %) 119 (53.35) 11 (15.11) . BLP. *For overall comparison between the three intervention arms.74) 41 (56.26) 56 (76.27) 9 (11.49) 20k–30k 32 (14.36 (7. Baylor College of Medicine.70) 11.72) 24.95) 1 (1.13 Homemaker 6 (2.70) 10 (14. n = 216) < 10k 21 (9. ISI.47) 32 (43.71) .36) 41 (55.96) 1. As for race.26) 44.22 ISI 11. %) 90 (40.88 Antidepressants (n. %) 86 (38.96 Assessment scores.68) 41.28) 10 (13.52 (2. %) 122 (54.78) 40.48 SF-12 PCS 42.11) 4 (5.64 (2.85 SIGH-A 19. Mental Component Scores of the Medical Outcomes Study Short Form. 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.40 (3.

13) Note: Two individuals (1 PLP and 1 UC) were missing the PCS.53) 5.655 .66 .71 .57) SIGH-A PLP 19.001 5.11) 45.72) 19.09 (11.06) 6.98 (6.17 .92 (4.20) UC 47.006 .97 (11.70 (3.010 .53 (9.007 .106 .0001 .46) 6.68 (9.031 BLP 11.024 29. 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 24.0001 .22 <.25 <.75 .21 (4.84 .81 .92 (8.66) 6.05) 7.14 <.26) .0001 .57 (7.018 4.16) 5.92 .0001 .77 (8.38 . TABLE 2.13 (11.89 (11.09) 14.91) 3.39 (10.78) 45.76 .17 (12.38 .61 (4.074 .88 (5.39 .42 . MCS.03) – – – 75.28) 22.88) 8.001 4.04) PCS PLP 41.64 .227 3.002 90.108 .30 (10.011 .20 .020 .011 31.005 1.006 .88 (7.027 BLP 9.58 .58 (8.58 (7.89 (6.021 .065 .98) MCS PLP 43.037 3.66 (11.003 .010 .260 6.20) 42.173 .63) UC 11.77 (10.16 <. and ISI at 6 months but are included in all other observed means.85 (10.009 5.54) 20.95 (9.010 BLP 24.29 .57) UC 10.24) 40.46) 15.75 (5.88) 42.59 .003 BLP 44.30 (9.81) Research Article: Lay Provider Delivery of CBT for GAD: An RCT UC 41.98 (10.78 (4.11 (12.70) 9.63) PHQ-8 PLP 9.16 <.36) 11.425 .45) 9.009 158.065 .759 .69 <.337 .029 BLP 11.001 45.99) UC 11.12) 39.009 .037 .0001 .30 (9.391 1.75 (10.780 .58 (7.34 (7.005 4.101 .00 (5.25 (10.53 .92 .14) UC 20.05 (7.68) 46.15 (4.203 .11 .36 (7.58 (10.81 (7.009 2.150 5.023 BLP 18.68) UC 25.18 (6.40) 49.018 69.72 (5.002 .0001 .04) ISI PLP 11.18 (5.61 .76 <.00 (12.08 .023 BLP 47.17 .84) GADSS PLP 11.017 .0001 .27) 7.26) 41.38) UC 40.024 8.77) 2.008 .83) 11.42) STAI-T PLP 46.70 (10. Depression and Anxiety 397 .034 BLP 42.019 6.22) .94 (10.10 .34) 19.

0) 20/52 (38.125 Completer 24/60 (40. completed were comparable across the two groups.[71] This type of “disruptive innovation” in mental healthcare delivery. Study attrition in BLP was higher (32%) but still both treatment groups. BLP t P g t P g t P g GADSS − 3.80 . ISI.798 .003 . proportion and competence among lay providers with no prior TABLE 4. Chi-square analyses indicated no sig.460 − 2. Response rates for those providing 6. with both groups showing sig. P = . g represents Hedge’s g.016 .457 .005 . UC: 28. but a significant group dif.420 MCS 3. of telephone sessions and average number of exercises χ 2 (2) = 1. suggesting 33%. to deliver evidence-based mental health care.[1] ing 6-month assessments.001 .781 . a measure of effect size. anxiety. Depression and Anxiety .03 .5) 13/68 (19. Study attrition overall (19%) and within the PLP nificantly improved GAD severity.-level providers.004 .398 Stanley et al.41 . with higher percentages of re.005 .1%). Treatment Response Rates.91 .015 .26 . patients in both groups rates in prior studies of CBT for late-life GAD (40%. nonresponders included patients without 6-month assessment data. due to the Bonferroni adjustment.17 . depressive group (19%) was lower than psychotherapy studies for symptoms.17 . the gap between evidence and practice that plagues cur- outcomes were comparable when CBT was conducted rent care models. the potential benefit of a personalized approach to treat- month data also were comparable for BLP and PLP. 8-item Patient Health Questionnaire. completion response rates were within the range of prior studies and not significantly higher than those for UC and comparable to response different from PLP. STAI-T. GADSS.75 . Pairwise comparisons to follow-up significant main effects of treatment PLP vs. usual care.[28] suggesting relative to UC.[75] by BLPs and PLPs.016 .28 . BLPs were ad.100 STAI-T − 2.0167. and mental health quality of life.3%.[39] attended equivalent numbers of sessions.60 .16 . TABLE 3. The ability to train lay providers who can offer psy- sponders in BLP (40%) and PLP (38.122 ISI − 2. ratings were lower for BLPs than PLPs. supervised ported in Table 4.34.4) 20/76 (34. bachelor-level providers.457 . BLP. SIGH-A).523 − 2.5%. GADSS. Significant strengths of this study include provider- herent and competent with treatment procedures.51) medications. Medical Composite Score of the 12-item Medical Outcomes Study Short Form.470 − . Moreover. late-life anxiety often report (21–39%). Although adherence and competence comparable engagement in treatment.010 . Trait subscale of the Spielberger State-Trait Anxiety Inventory.002 . to ference occurred in response rates for patients complet.[72–74] challenges DISCUSSION traditional ideas about service delivery but might bridge Among older adult primary care patients with GAD.61 .98 .5%) relative to UC chosocial care with sufficient supervision and over- (19.43 . For ITT analyses.543 . ITT. by a licensed provider.425 .8) 4.2%. UC. insomnia.026 SIGH-A − 2. UC PLP vs. UC.566 2. In ment. usual care. bachelor-level providers. PLP: 38. Percent of treatment These outcomes support the utility of lay providers responders for both ITT and completer analyses are re.-level providers. along with recent advances in technology-based interventions.403 − 2. MCS. sight increases potential access and reach of evidence- based care. PLP.398 − . SIGH-A.[51] 45%[58] ). force. BLP.D.042 PHQ-8 − 3.500 − 2.44 .85 .79 .480 − 2.426 . Generalized Anxiety Disorder Severity Scale. Structured Interview Guide for the Hamilton Anxiety Scale. PHQ-8. and are directly relevant to re- nificant group differences in response rates at 6 months cent IOM recommendations to develop a broader work- according to ITT analyses.56 . UC BLP vs.019 Note: Figures indicate the number (percentage) of individuals with a reduction of 20% in three of four primary outcomes (PSWQ-A. Insomnia Severity Index. antidepressant (BLP: 33. Ph.1) 13/73 (17.D. STAI-T.462 − .011 .131 Note: The P values for the pairwise comparisons were evaluated at P < . intent to treat.395 − . PLP. and training procedures that produced good adherence the average number of treatment sessions. reduce barriers to mental health care for older adults. Ph.873 .43 <. Treatment response rates at 6 months N (%) PLP BLP UC χ2 P ITT 24/74 (32. supported sufficiently by specialty providers.1) 7.82 .005 .

D. Wennerstrom A. Ingram M. Petersen NJ. thors would like to thank Gretchen Diefenbach. the National Institutes of Health. and coexistent anxiety. Allen CE. The NIMH had no role in the de- alizability of study findings is limited. Cochrane Database Syst Rev 2005. 6. Naslund JA. activities and training.36(2):316–331.C. Montgomery EC. Bremmer MA. a national study of roles. interrater agree- ment for diagnosing GAD was not as high as for other 1. 8.34(3):247–259.13(10):717–726.D. Covinsky KE. Healthy I.. N Engl J Med 2013. Reinschmidt KM. Schmaling K. or approval of the manuscript. accord- and age-of-onset distributions. Rush CH.1. and Diane Novy. and somatization disorders later life: a report from the Longitudinal Aging Study Amsterdam. and anxiety disorders among older adults: the National Comorbid- 2 Principal diagnosis was the disorder with the highest severity rating. Native. and had higher income than review.37(2):529–537.D. Lifetime prevalence 1 Participants were asked to self-identify race and ethnicity. et al. Implementing evidence- This study paves the way for future effectiveness and based psychotherapies in settings serving older adults: challenges implementation trials of CBT for late-life GAD in other and solutions. 39. 9. Chowdhary N. Paraprofes- ity. Anxiety disorders in agnoses. Snowden M. M. Heying S. input of three anonymous reviewers. black. ing the system requirements and costs for two key 5.D.67(5):489–496. 2012. et al. This research was supported intervention for depressive and anxiety disorders in India: impact by a grant from the National Institute of Mental Health on clinical and disability outcomes over 12 months. Ph.. multiracial.. who provided rat. et al. Patel V.: Institute of prior work documenting weaker agreement for GAD Medicine. Stanley MA. Byers AL. Wiggins N. and Derek Hopko. J Appl Gerontol 2007. defining the field. affective. Rosenthal EL. et al .74(1):45– ings of treatment integrity. the US government or Baylor with flexibility in content and delivery options. Key implementation issues include defin. 16. likely given the absence of adults and mental health care. viduals received financial compensation from the grants 12. et al.S. Gum A. sionals for anxiety and depressive disorders. collection. et al. or other. 7. The au. The authors also appreciate the in low-income older adults. and Bruce Rollman. Demler O. Yaffe K. Hawaiian or Islander. et al. 62. randomized controlled trial. R01-MH53932) to the first author and by the 2011. Anderson Cancer Center. Stanley MA. 2. because sign and conduct of the study. McCulloch CE. or the for both BLP and PLP groups. The underside of the silver tsunami—older than other anxiety disorders. Deeg DJ. et al. 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