the efficacy of psychosocial treatments in primary care: a review of randomized clinical trials

11
Psychiatry and Primary Care Recent epidemiologic studies have found that most patients with mental illness are seen exclusively in primary care medicine. These patients often present with medically unexplained somatic symptoms and utilize at least twice as many health care visits as controls. There has been an exponential growth in studies in this interface between primary care and psychiatry in the last 10 years. This special section, edited by Wayne J. Katon, M.D., will publish informative re- search articles that address primary care-psychiatric issues. The Efficacy of Psychosocial Treatments in Primary Care A Review of Randomized Clinical Trials Charlotte Brown, Ph.D. and Herbert C. Schulberg, Ph.D. Abstract: Depression and anxiety are the most common psy- chiatric disorders among ambulatory medical patients and are associated with significantfunctional disability. However, they remain underrecognized andlor inadequately treated. The AHCPR Depression Guideline Panel recently reviewed the ef- ficacy of pharmacologicinterventions for mood disorders in the prima y caresector, but there are asyet no comparable analyses of the efficacy of psychosocial interventions for primary care patients experiencing depression OY anxiety. This review of randomized, controlled trials conducted in primary care set- tings generally supports the efficacyof psychosocial treatments (PSTs) provided to ambulatory medical patients with psychi- atric disorders. However, methodologic deficiencies in these trials (i.e., diagnostic classificationof study subjects,attrition patterns, and criteria for assessing treatment response)limit thegeneralizability of theirfindings fo routine practice. Studies evaluating the effect of PSTson health care costand utilization found changes in physicians’ prescribing practices, patients’ use of psychotropicmedication, and number of patient visits to prima y care physicians. However, results varied acrossstud- ies because of methodologic deficiencies similar to those noted previously. Suggestionsare offered for improving the internal and external validity of randomized PST trials in prima y care settings. University of Pittsburgh School of Medicine and Western Psychiatric Institute and Clinic, Pittsburgh, Pennsvlvania Address reprint requests to:.CharlottgBrown, eh.D., West- ern Psychiatric Institute and Clinic, 3811 O’Hara Street, Pitts- burgh, PA 15213. 414 ISSN 0163-8343/95/$9.50 SSDI 0163-8343(95)00072-Y Introduction Epidemiologic studies administering standardized diagnostic interviews to American primary care patients have found the prevalence of mental dis- orders in this population to range from 15% to 31% [l-5]. Depression and anxiety, the most common psychiatric disorders among ambulatory medical patients, are associated with functional disability rivalling or exceeding that found among chronic illnesses. Not surprisingly, they also lead to exces- sive health care utilization and increased medical costs [6]. Despite the high prevalence of diagnos- able psychiatric disorders, most studies have found that they remain underrecognized and/or inadequately treated [7]. The need for intervention is clear and although many medical patients are treated for mental dis- orders in the primary care setting [8], the efficacy of treatments provided them remains unclear. The NIMH Consensus Development Panel on Depres- sion [9] cautioned against generalizing findings about the treatment of mood disorders in psychi- atric patients to other clinical populations. Kupfer and Freedman [lo], and Keller and Lavori [ll] sim- ilarly urged researchers to conduct treatment effi- cacy studies with the populations for whom the intervention is intended. Almost a decade later, General Hospital Psychiatry 17, 414-424, 1995 0 1995 Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010

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Page 1: The efficacy of psychosocial treatments in primary care: A review of randomized clinical trials

Psychiatry and Primary Care Recent epidemiologic studies have found that most patients with mental illness are seen exclusively in primary care medicine. These patients often present with medically unexplained somatic symptoms and utilize at least twice as many health care visits as controls. There has been an exponential growth in studies in this interface between primary care and psychiatry in the last 10 years. This special section, edited by Wayne J. Katon, M.D., will publish informative re- search articles that address primary care-psychiatric issues.

The Efficacy of Psychosocial Treatments in Primary Care A Review of Randomized Clinical Trials

Charlotte Brown, Ph.D. and Herbert C. Schulberg, Ph.D.

Abstract: Depression and anxiety are the most common psy- chiatric disorders among ambulatory medical patients and are associated with significantfunctional disability. However, they remain underrecognized andlor inadequately treated. The AHCPR Depression Guideline Panel recently reviewed the ef- ficacy of pharmacologic interventions for mood disorders in the prima y care sector, but there are as yet no comparable analyses of the efficacy of psychosocial interventions for primary care patients experiencing depression OY anxiety. This review of randomized, controlled trials conducted in primary care set- tings generally supports the efficacy of psychosocial treatments (PSTs) provided to ambulatory medical patients with psychi- atric disorders. However, methodologic deficiencies in these trials (i.e., diagnostic classification of study subjects, attrition patterns, and criteria for assessing treatment response) limit thegeneralizability of theirfindings fo routine practice. Studies evaluating the effect of PSTs on health care cost and utilization found changes in physicians’ prescribing practices, patients’ use of psychotropic medication, and number of patient visits to prima y care physicians. However, results varied across stud- ies because of methodologic deficiencies similar to those noted previously. Suggestions are offered for improving the internal and external validity of randomized PST trials in prima y care settings.

University of Pittsburgh School of Medicine and Western Psychiatric Institute and Clinic, Pittsburgh, Pennsvlvania

Address reprint requests to:.CharlottgBrown, eh.D., West- ern Psychiatric Institute and Clinic, 3811 O’Hara Street, Pitts- burgh, PA 15213.

414 ISSN 0163-8343/95/$9.50 SSDI 0163-8343(95)00072-Y

Introduction Epidemiologic studies administering standardized diagnostic interviews to American primary care patients have found the prevalence of mental dis- orders in this population to range from 15% to 31% [l-5]. Depression and anxiety, the most common psychiatric disorders among ambulatory medical patients, are associated with functional disability rivalling or exceeding that found among chronic illnesses. Not surprisingly, they also lead to exces- sive health care utilization and increased medical costs [6]. Despite the high prevalence of diagnos- able psychiatric disorders, most studies have found that they remain underrecognized and/or inadequately treated [7].

The need for intervention is clear and although many medical patients are treated for mental dis- orders in the primary care setting [8], the efficacy of treatments provided them remains unclear. The NIMH Consensus Development Panel on Depres- sion [9] cautioned against generalizing findings about the treatment of mood disorders in psychi- atric patients to other clinical populations. Kupfer and Freedman [lo], and Keller and Lavori [ll] sim- ilarly urged researchers to conduct treatment effi- cacy studies with the populations for whom the intervention is intended. Almost a decade later,

General Hospital Psychiatry 17, 414-424, 1995 0 1995 Elsevier Science Inc.

655 Avenue of the Americas, New York, NY 10010

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Psychosocial Treatments in I’rimarv Care Practice

these concerns persist. Thus, the paucity of data regarding the efficacy of treatments provided to depressed primary care patients was again noted by the AHCPR Depression Guideline Panel [12], and it reemphasized the need for pertinent clinical trials to be conducted in ambulatory medical set- tings.

Anticipating that investigators will heed this un- answered call within the coming years, what should they know about treatment efficacy studies completed to date in the primary care sector? The AHCPR Depression Guideline Panel [12] per- formed meta-analyses of the mood disorder phar- macotherapy clinical trials conducted between 1975 and 1990, but no comparable analyses are yet available about the efficacy of psychosocial treat- ments (PSTs) for this disorder when delivered in primary care settings. Even less is known about the efficacy of treatments for other disorders such as anxiety and somatization which also are preva- lent in primary care practice. This paper, therefore, analyzes published primary care randomized clin- ical trials (RCT) of PSTs and draws tentative con- clusions from this body of earlier work. Both sub- stantive and methodologic suggestions are then offered to investigators undertaking the next gen- eration of primary care PST efficacy studies.

Method A Medline search was performed for the years 1974 to 1995 using the key-words general practice, primary care, ambulatory medical patients, health maintenance organization, psychotherapy, cogni- tive therapy, counseling, PST, and behavioral treatment. Studies of PSTs for substance abuse/ dependency, emergency room admissions, smok- ing, obesity, chronic medical problems (e.g., myo- cardial infarction, peptic ulcer disease, irritable bowel syndrome), and marital and family therapy were not reviewed since they involve disorders typically cared for, and/or interventions usually provided, in specialist settings. Given these crite- ria, we identified 18 studies in which the efficacy of PSTs for mental disorders was studied in primary care centers with a research design utilizing ran- domized assignments to either the experimental or control/comparison condition.

Our review is organized in keeping with the type of outcome criterion reported by the investi- gator. Thus, we distinguish studies that evaluated treatment efficacy on the outcome criterion of symptomatic improvement from studies that ex-

amined efficacy in relation to health care utiliza- tion. Within this larger framework, we subclassify studies according to the investigator’s strategy for assessing a patient’s mental disorder. Conse- quently, studies that classified a patient’s severity of psychological distress or disorder-specific symp- tomatology on the basis of a psychiatric rating scale, questionnaire, psychiatric interview, or phy- sician referral are distinguished from studies that classified psychopathology through a structured diagnostic interview. In addition to analyzing treatment outcomes obtained in each of these as- sessment categories, when possible, we indicate whether the analyses were based on intent-to-treat or treatment completer samples and the attrition patterns associated with specific psychosocial in- terventions.

Studies of Symptomatic Impruvemeurt

Patient Selection Using Nonstructured Assess- ments. In 10 randomized trials evaluating symp- tomatic improvement following a psychosocial in- tervention, the assessment methods for selecting study patients utilized physician referral [X3-18], psychiatric interviews [19,20], and screening with the General Health Questionnaire (GHQ) ]21,22]. As a result, the patient cohorts were likely diag- nostically heterogeneous. Further, the pretreat- ment level of symptomatic severity among cases could not be determined in most of these trials.

Several studies showed no significant clini- cal outcome differences between a psychosocial intervention and the comparison condition [ 13,14,18,19,21]. However, all studies using man- ualized treatments found that psychotherapy pro- duced significantly greater reductions in psycho- logical symptoms than the “usual care” provided by a general practitioner, no treatment, or phar- macotherapy [ 16,17,20,22]. In addition, Robson et al. [15] found that individual behavior therapy combined with “usual care” produced greater symptomatic improvement than “usual care” alone (see Table 1).

We sought to determine what design features (e.g., heterogeneity of sample, discipline of thera- pist, type and specificity of treatment) were related to outcomes. Although PST was provided by men- tal health specialists (psychiatrists, clinical psy- chologists, and psychiatric nurses) in all but two studies [14,21], discipline of the therapist could not be evaluated in relation to treatment efficacy be- cause there were not enough studies with any sin-

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gle provider type to permit this analysis. More im- portantly, most studies finding psychotherapy su- perior to “usual care” selected more homogeneous patient populations and provided manualized therapy.

In the Ginsberg et al. [20] and Marks [16] stud- ies, phobic and obsessive compulsive patients re- ceiving individual behavior therapy from nurse therapists achieved greater symptomatic improve- ment than similar patients receiving “usual care.” Lindsay et al. [22] found that patients with gener- alized anxiety disorder receiving cognitive- behavior therapy or anxiety management training (provided by psychologists) did not differ from each other after treatment but both demonstrated greater symptomatic improvement than the con- trol and pharmacotherapy groups. The control group did not change over the course of the trial, whereas the pharmacotherapy group showed sig- nificant initial improvement which declined mark- edly by treatment’s end. Catalan et al. [17] identi- fied patients with anxiety, depression, or somatic symptoms. Those randomized to problem-solving therapy provided by psychiatrists achieved a greater reduction in psychiatric symptoms than did patients receiving “usual care.” Robson et al. [15] also selected a diagnostically mixed sample, and found that patients treated by clinical psychol- ogists with individual behavior therapy in addition to “usual care” achieved better clinical outcomes than patients receiving “usual care” alone.

Overall, the findings from trials using unstruc- tured assessments to enroll subjects are equivocal. While half of these trials found psychosocial treat- ments to produce significantly better symptomatic improvement and clinical outcomes than “usual care” [15,16,17,20,22] the remainder found no dif- ferences between the two treatment modalities. It appears that PSTs are more efficacious when man- ualized, and when the PST cohorts are less diag- nostically heterogeneous.

Patient Selection Using Criterion-Based Diag- nostic Assessments. Six randomized trials of PSTs for major depression [23-281, one for minor de- pression [29], and one for generalized anxiety dis- order [30] selected subjects with a criterion-based psychiatric assessment. The assessment instru- ments included the Present State Examination [31], Goldberg’s Standardized Psychiatric Interview [32], and the National Institute of Mental Healths Diagnostic Interview Schedule [33] to identify pa-

tients meeting Research Diagnostic Criteria [34] for major depressive disorder. Findings from these in- vestigations generally attest to the efficacy of psy- chosocial interventions when delivered in primary care settings (see Table 2). Most researchers used manualized treatments delivered by mental health specialists, except for Holden et al. [26] whose study patients were counselled by health visitors, and Mynors-Wallis et al. [28] who trained general practitioners as well as psychiatrists to provide problem-solving therapy.

Blackburn et al. [23] found cognitive therapy and combined cognitive therapy-pharmacotherapy each superior to pharmacotherapy alone in treat- ing both depressed hospital outpatients and gen- eral practice patients. Teasdale et al. 1241 found general practice patients receiving cognitive ther- apy to be more improved at the completion of treatment than those receiving “usual care.” How- ever, the two groups did not differ significantly at 3-month follow-up, mainly as a result of the “usual care” group’s continuing improvement. Similarly, Ross and Scott [25] found group cognitive therapy superior to “usual care”; the cognitive therapy pa- tients maintained their clinical improvement 3, 6, and 12 months later. Scott and Freeman [27] found that among patients provided pharmacotherapy, cognitive behavior therapy, or social work coun- selling, only the latter was superior to “usual care.” Mynors-Wallis et al. [28] found that prob- lem-solving therapy produced better clinical out- comes than placebo, but did not differ from phar- macotherapy at 6 and 12 weeks. Finally, women with postpartum depression counselled by health visitors showed a greater reduction in depressive symptoms than those receiving no treatment [26].

Recent investigations have indicated that the psychologic distress and functional impairment as- sociated with minor depression and possibly in- creased health care costs due to excessive utiliza- tion emphasize the need for this disorder to be appropriately treated within the primary care sec- tor [6,35,36]. However, to date, only one pub- lished randomized controlled trial has evaluated the effectiveness of a PST for minor depression in ambulatory medical practice. Miranda and Munoz [29] found that patients with minor depression re- ceiving a depression prevention course based on cognitive-behavioral principles had greater reduc- tions in depressive and somatic symptoms than patients not receiving this intervention. Symptom- atic improvement was maintained through the

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Table 1. Studies using nonstructured assessments

Authors Inclusion criteria N Intervention Attrition

N (%I Outcome findings

1131 Symptoms of anxiety and stress

50

1191 Symptoms of anxiety or depression

44

VI Psychological symptoms for 6 months or more

68

P41 Psychiatric disorder requiring an anxiolytic

91

Behavior therapy (BT) Usual care (UC)

8 (16%)

Cognitive behavior group therapy

Interpersonal group therapy

Individual cognitive behavior therapy

Problem-oriented dynamic psychotherapy

Family practitioner therapy

9 (20%)

12 (18%)

PO1 Neurotic patients (mostly phobics and obsessive compulsives)

92 BT UC

Anxiolytic medication Brief counseling

4 (4%)

26(280/o)

No differences between BT and UC on measures of psychological distress, BT patients received less psychotropic medication than UC patients during the course of treatment, but not at i-month follow-up. ‘rhe groups did not differ on use of other medications or physician visits

No differential treatment effect. All groups had significant improvement in depressive and anxiety svrnptom~

No differential treatment effect at posttreatment or 12-month follow-up, Both groups improved significantly on symptom severity and Social dysfunction but not on physical disability and medication use

No differential treatment effect. Both groups showed significant improvement ii) psychiatric symptoms and social tunctioning at posttreatment and T-month follow-up. No difference between groups in thtt proportion of patients with GHQ al2 at posttreatment

BT patients had greater reduction m fear and anxieiy and greater improvement in target problem than UC patients. Compared with the year before entering the trial, BT patients had a decrease in physician visit costs.

UC patients had an increase in health resource usage costs. BT and UC patients did not differ in medication llsage costs

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Table 1. (Continued)

Authors Inclusion criteria N Intervention Attrition

N (%) Outcome findings

1151 Neurotic patients (mostly phobics and obsessive compulsives)

429 BT UC

Not reported

WI Neurotic patients (mostly phobics and obsessive compulsives)

92 BT UC

WI Chronic anxiety (21 year)

1171

WI

Anxiety, depression, or somatic symptoms not due to physical illness

Acute episode of emotional disorder or long-term problem with recent increase in symptoms

26(28%)

40 Cognitive behavior-therapy WV

Anxiety management training (AMT)

Benzodiazepine (BZ) Waiting list control

WV

1 (3%)

47 Problem-solving therapy (PST)

UC

0 (0%)

24 Brief psychotherapy (BP)

UC

2(8%)

Both groups improved. BT patients had greater and more rapid improvement in target problem than UC patients. BT patients made fewer physician visits and used less psychotropic medication than UC patients at posttreatment and 6-month follow-up. The groups did not differ in other medication costs.

BT patients showed greater improvement in target problem, anxiety, depression, and work and social functioning than UC patients. UC patients who were crossed over to BT also showed significant symptomatic and functional improvement

Patients receiving CBT or AMT had greater reduction in anxiety symptoms than BZ or WL patients. At 3-month follow-up there was no difference between AMT and CBT patients in level of anxiety

PST patients had greater improvement in psychiatric symptoms than UC patients at posttreatment and 4-month follow-up

No differential treatment effect

No symptomatic or functional improvement in patients receiving BP or UC

l-year follow-up. Control subjects with low levels patients with generalized anxiety disorder and of initial depression showed no change in somatic compared the efficacy of cognitive-behavior ther- symptoms following treatment. apy, diazepam, and placebo. All three treatment

One randomized trial [30] targeted primary care groups improved significantly on measures of

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Table 2. Studies using criterion-based diagnostic assessments

Authors Inclusion criteria N Intervention Attrition

N (%I

[231 Major depression (RDC criteria)

88 CT group Pharmacotherapy (PT) CT+PT

24 (27%)

[241 Major depression 44 Individual CT + UC (RDC criteria) UC

t251 Major depression (RDC criteria)

51 Group CT Individual CT UC

Major or minor postnatal depression (RDC criteria)

55 Nondirective counseling

No treatment control

[271 Major depression (DSM-III-R)

121 PT Cognitive behavior

therapy (CBT) Social work counseling

ww UC

10 (23%)

11 (22%)

5 (9%)

7 (6%)

- --. ---.-___

Outcome findings ----.-----------

CT and CT-+ PT patients had greater improvement in psychiatric symptoms than PT pahents.

CT patients d4d not differ from CT + 1‘7 patients in improvement of psychiatric symptoms

CT patients had greater improvement in depressive symptoms than UC patients. At 3-month follow-up there were no differences between the* groups

CT patients showed greater improvemr:lt in depressive *vmptoms than CC pat&s. Improvement was maintained at I2-month follow-up. i here was no difference between CT treatment ntodalities

Greater proportion of treated pahc‘nts no ionger met criteria for major or m!no! depression

Treated patients had a reduction iI: depressive symptoms; controls showed no change

All groups showed marked improvement in depressive bymptoms at 4 months. b)nly SWC patients shcnved greater improvement in depressive symptoms than UC patients at 4 months. The cost of the three specialist treatments were similar. The cost ot UC was less than half that of specialist care. SWC had higher pauenl satisfaction ratings than UC or r2

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Table 2. (Continued)

Authors Inclusion criteria N Intervention Attrition

N (%) Outcome findings

[291 Minor depression (RDC criteria)

150 Cognitive behavioral depression prevention course (CB course)

No intervention control

56 (37%)

WI Major depression (RDC criteria)

91 Problem-solving therapy (PST)

PT Drug placebo

[301 Generalized anxiety disorder (RDC criteria)

33 CBT Diazepam Placebo

26 (29%)

2 (6%)

Patients in CB course had greater reduction in depressive and somatic symptoms than controls.

Symptomatic improvement was maintained through l-year follow-up. Nondepressed controls did not have a reduction in somatic symptoms. Compared with controls, intervention patients missed fewer medical appointments during the year following treatment, but there was no change in number of medical visits and drop-in appointments

PST patients had greater improvement in depressive symptoms and social functioning than placebo patients but did not differ from PT patients at 6 and 12 weeks. Compared with placebo, a greater proportion of patients receiving PST or PT met criteria for clinical recovery (HRS-D s 7)

No differential treatment effect on general distress measures. All three groups improved. Only CBT patients had significant improvement during treatment. All groups had improvement in anxiety symptoms. CBT patients had greater improvement than placebo patients, but did not differ from diazepam patients

general distress and anxiety symptoms, but only patients receiving cognitive-behavior therapy showed gains exceeding those of the placebo group. There was no outcome difference in levels

of anxiety symptoms between patients treated with pharmacotherapy and cognitive-behavior therapy.

The above studies indicate again that diagnostic

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homogeneity of study samples and treatment specificity likely contribute to the efficacy of psy- chosocial interventions. All but one study [27], which used a criterion-based psychiatric assess- ment (producing more homogeneous patient co- horts) and manualized treatments (mostly cogni- tive-behavior therapy), found psychotherapy more efficacious than placebo, no treatment, or “usual care.” When pharmacotherapy was compared to cognitive-behavior and problem-solving therapy, three studies found no differences between the treatments [27,28,30] but a fourth found cognitive- behavior therapy superior to pharmacotherapy ]231.

Taken as a whole, this body of 18 randomized trials is divergent with regard to subject selection procedures as well as other design characteristics. Only a few investigators detailed the recruitment and retention process by specifying the number of patients screened, number who refused psychiat- ric evaluation, number eligible for treatment, and number accepting randomization. In terms of out- come criteria for assessing recovery, only five of the investigators specified clinically derived oper- ational criteria for measuring treatment responses. Catalan et al. [14] evaluated the proportion of pa- tients meeting criteria for ‘case status’ pre- and posttreatment; Biackburn et al. 1231 analyzed whether subjects attained a 50% reduction in base- line Hamilton Rating Scale-Depression (HRS-D) or Beck Depression Inventory (BDI) score; Holden et al. [26] required that patients no longer meet diag- nostic criteria for major or minor depression; and Scott and Freeman [27] and Mynors-Wallis et al. [28] classified patients as clinically recovered if their I-IRS-D score was ~7 or if their BDI score was ~8. The remaining investigators simply deter- mined whether statistically significant changes were evident on given measures following treat- ment. This methodologic variation makes it diffi- cult to compare treatment efficacy rates across studies, and to determine whether statistically sig- nificant changes are also clinically meaningful. Furthermore, even among studies using common symptom inventories (e.g., BDI, HRS-D, and Gen- eral Health Questionnaire), the statistical mea- sures of change in patient functioning (i.e., mean, median, and percentage change score) differed sufficiently to prevent meta-analyses of the mag- nitude of treatment effect.

Finally, only three RCTs reported outcome find- ings using an intent-to-treat sample [25,28,29]. The remaining 15 studies presented data obtained only

from subjects completing the entire trial. Though the latter analytic strategy provides valid informa- tion about the efficacy of treatments for subjects participating in the full protocol, a treatment’s ef- ficacy with all clinically eligible patients must be evaluated by including data for all subjects as- signed to it. For example, if poor outcome patients tend to drop out of treatment but the correspond- ing patients are not lost to follow-up In the control group, then excluding treatment dropouts from the analysis may lead to the inappropriate conclu- sion that the treatment was effective. including pre- mature terminators in outcome analyses typically re- duces the treatment’s efficacy rate. Nevertheless, in- tent-to-treat samples more validly mdica te the intervention’s usefulness for a total population.

All of the 18 reported trials assessed changes in psychiatric symptoms, but only five assessed psy- chosocial functioning [14,16,18,21,28]. Three found no change in a patient’s level of functioning favoring PST over “usual care” [14,18,X], and two found significant functional improvement follow- ing psychotherapy [16,28]. Ginsberg et al. [20] compared a patient’s work disabilitv before and after behavioral treatment, but found no signifi- cant change over time.

Studies of Health Services Utilizatim

Given current efforts to reform health care and their emphasis on reducing costs, we have re- viewed RCTs evaluating the effect of PSTs on health care utilization (see Tables 1 arid 2). Al- though determining whether a psychosocial inter- vention produces a cost offset, i.e., reduces the use of nonpsychiatric medical services, is of vital con- cern, only four studies have considered this issue [13,15,20,29].

The investigators’ evaluation of health services utilization included pre- and postintervention comparisons of the number of patient visits to a primary care physician, number of missed ap- pointments, number of prescriptions filled, and number of outpatient appointments. Two of the studies also assessed the cost of prescriptions and/ or hospital inpatient or outpatient medical visits. Regarding the latter measures, both Earl1 and Kincey [13] and Robson et al. [15] found that too few patients had hospital admissions or outpatient visits to permit formal analysis.

Health care utilization patterns following a psy- chosocial intervention varied across studies. Earl1 and Kincey [13] found that treated patients aver-

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aged 7.7 therapy sessions and used less psycho- tropic medication than controls, but showed no change in the number of visits to their general practitioner. The difference between controls and treated patients in their use of psychotropic med- ication was maintained at 7-month follow-up. Rob- son et al. found that treated patients averaged 3.7 therapy sessions, used less psychotropic medica- tions than controls, and made fewer visits to their general practitioner at treatment’s end and at 6-month follow-up. Ginsberg et al. [20] found that although treated patients visited their general practitioner less frequently than controls, they did not differ from controls in their use of psychotropic medications. Finally, Miranda and Munoz [29] found that patients in the intervention group com- pared with an untreated control group had fewer missed appointments with their primary care phy- sician in the year following treatment. They did not, however, differ from controls in the number of scheduled medical visits or drop-in appoint- ments. Neither Ginsberg et al. nor Miranda and Munoz reported the mean number of treatment sessions for study subjects, and so the relationship between treatment intensity and health services utilization could not be ascertained in their pro- grams.

Attrition Rates

The mean attrition rate among the previously re- viewed RCTs was 16.7%, with a median rate of 18% and a range of 0%-37% (see Tables 1 and 2). Although all but one study reported the number of patients leaving treatment prematurely, the re- ports varied in specifying the actual point at which dropout occurred (e.g., before first treatment ses- sion, after one to two sessions, during treatment).

Discussion

The findings from RCTs conducted in primary care settings generally support the efficacy of PSTs pro- vided to ambulatory medical patients with psychi- atric disorders. This conclusion is consistent with that derived from studies of the efficacy of PSTs provided psychiatric patients in mental health set- tings [37]. Nevertheless, the primary care studies have significant methodologic deficiencies which constrain the generalizabihty and applicability of their findings to routine medical practice. As was indicated in our literature review, these deficien-

cies pertain to the diagnostic classification of study subjects, attrition patterns experienced in the de- livery of treatment, and criteria for assessing treat- ment response. We will comment briefly on each of these design considerations, with the aim of alerting investigators to key factors that can en- hance or detract from the internal and external va- lidity of their research.

A major step in upgrading the quality of psychi- atric research occurred during the 1970s with the development of Research Diagnostic Criteria and similar frameworks for standardizing diagnostic classifications. Though DSM-based criteria have since been central to RCTs conducted in psychiat- ric centers, their application to primary care re- search is a more recent development. Thus, only 8 of the 18 RCTs reviewed here selected patients with a structured diagnostic assessment proce- dure. The majority of prior RCTs utilized symptom or distress inventories to assess study subjects, thus unwittingly enrolling diagnostically heterog- enous populations in their protocol. A possible ef- fect of this procedure on treatment outcome is ev- idenced in our finding that protocols selecting di- agnostically homogenous groups most consistently found PSTs efficacious. This is not surprising since the applied intervention typically was disorder-specific, e.g., it was designed to re- solve an episode of depression but not anxiety.

A second methodologic consideration requiring the investigator’s attention in designing an RCT and analyzing its findings is the attrition pattern associated with the PST compared with alternative interventions. If the tested treatments encounter markedly different experiences in this respect, their relative clinical efficacy and cost-effectiveness may well be affected [38]. Despite the significance of this issue, few investigators provided suffi- ciently detailed information to compare attrition patterns across psychosocial and other treatments. Knowledge about modal points of attrition from PST is also necessary to alert clinicians to the time intervals at which patients are at highest risk to prematurely terminate participation in the thera- peutic process. As Katon et al. [39] have sug- gested, many primary care patients are quite am- bivalent, if not opposed, to acknowledging their psychiatric morbidity. Given the likely ensuing re- sistance to treatment, investigators of psychosocial treatment efficacy should test clinical strategies for minimizing attrition at critical risk points.

The third methodologic concern pertains to the measures as well as criteria to be used in assessing

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PST response. With regard to outcome measures, a diverse array was utilized in prior Rffs. They in- cluded measures that are disorder-specific and those focusing on broader general distress mea- sures that assess diagnostic status, and those con- cerned only with symptomatic status. Combining these varied measures in a single meta-analysis of PST efficacy involves assumptions of often un- tested validity, e.g., are the reduced symptomatic benefits of a disorder-specific treatment the equiv- alent of improved social role functioning? Even when measures of a PST’s impact are standard- ized, there still remains the need to operationalize criteria for classifying a patient’s outcome status. As Prien et al. [40] and Schooler [41] have noted, determining whether pre-post scores have changed at a statistically significant level may or may not have clinical relevance. Moreover, statistical tests of change typically fail to inform the clinician about the important course of illness markers such as remis- sion, relapse, and recurrence. Given this void, Frank et al. [42] proposed criteria for classifying a patient’s depressive status at critical time points based on HRS-D or BDI scores. However, additional similar work is still needed. For example, researchers inves- tigating PSTs of panic disorder still lack operational criteria for defining clinical response, remission, re- covery, relapse, and recurrence [43].

Finally, the several RCTs investigating whether PSTs reduce the cost and utilization of health ser- vices suggest this to be the case. Physicians’ pre- scribing practices and patients’ use of psychotropic medication were altered, as were the patients’ number of visits to their primary care physicians and number of missed appointments. However, these outcomes were not consistent across studies. This is best understood in terms of the heteroge- neity of patient samples, suggesting once again that future research on a PST’s cost-offset effect in primary care practice should focus upon homoge- neous diagnostic categories. Service utilization patterns conceivably differ among patients with depressive and anxiety disorders, among those with differing severity levels, and among those with differing degrees of comorbid medical illness.

This research was supported by the National lnstitute of Mental Health Research Grant MH45875 (HCS) and training Grant MH18269 (CB).

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