Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. II: cost effectiveness. Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy and usual general practitioner care in the management of depression as well as mixed anxiety and depression in primary care. Cost-benefit analysis of a controlled trial of nurse therapy for neuroses in primary care. PHASE: a randomised, controlled trial of supervised self-help cognitive behavioural therapy in primary care. Randomised controlled assessment of non-directive psychotherapy versus routine general-practitioner care. Intervention to improve psychological functioning for newly diagnosed patients with cancer. London-East Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. I: effects of the treatment phase. A randomized controlled trial and economic evaluation of counselling in primary care. The Utrecht comparative study on psychiatric day treatment and inpatient treatment. Efficacy of inpatient and home treatment in psychiatrically disturbed children and adolescents. Follow-up assessment of the results of a controlled treatment study. A randomised controlled trial to evaluate the effectiveness and cost-effectiveness of counselling patients with chronic depression. Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial. Antidepressant drugs and generic counselling for treatment of major depression in primary care: randomised trial with patient preference arms. Randomized trial of coordinated psychosocial interventions based on patient self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. Cognitive therapy, analytic psychotherapy and anxiety management training for generalised anxiety disorder.
To compare the cost effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients.
                Prospective, controlled trial with randomised and patient preference allocation arms.
                General practices in London and greater Manchester.
                464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion.
                Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists.
                Beck depression inventory scores, EuroQol measure of health related quality of life, direct treatment and non-treatment costs, and cost of lost production.
                197 patients were randomly assigned to treatment, 137 chose their treatment, and 130 were randomised only between the two psychological therapies. At four months, both non-directive counselling and cognitive-behaviour therapy reduced depressive symptoms to a significantly greater extent than usual general practitioner care. There was no significant difference in outcome between treatments at 12 months. There were no significant differences in direct costs, production losses, or societal costs between the three treatments at either four or 12 months. Sensitivity analyses did not suggest that the results depended on particular assumptions in the statistical analysis.
                Within the constraints of available power, the data suggest that both brief psychological therapies may be significantly more cost effective than usual care in the short term, as benefit was gained with no significant difference in cost. There are no significant differences between treatments in either outcomes or costs at 12 months. The aim of this study was to determine both the clinical and cost-effectiveness of usual general practitioner (GP) care compared with two types of brief psychological therapy (non-directive counselling and cognitive-behaviour therapy) in the management of depression as well as mixed anxiety and depression in the primary care setting.
                The design was principally a pragmatic randomised controlled trial, but was accompanied by two additional allocation methods allowing patient preference: the option of a specific choice of treatment (preference allocation) and the option to be randomised between the psychological therapies only. Of the 464 patients allocated to the three treatments, 197 were randomised between the three treatments, 137 chose a specific treatment, and 130 were randomised between the psychological therapies only. The patients underwent follow-up assessments at 4 and 12 months.
                The study was conducted in 24 general practices in Greater Manchester and London.
                A total of 464 eligible patients, aged 18 years and over, were referred by 73 GPs and allocated to one of the psychological therapies or usual GP care for depressive symptoms.
                The interventions consisted of brief psychological therapy (12 sessions maximum) or usual GP care. Non-directive counselling was provided by counsellors who were qualified for accreditation by the British Association for Counselling. Cognitive-behaviour therapy was provided by clinical psychologists who were qualified for accreditation by the British Association for Behavioural and Cognitive Psychotherapies. Usual GP care included discussions with patients and the prescription of medication, but GPs were asked to refrain from referring patients for psychological intervention for at least 4 months. Most therapy sessions took place on a weekly basis in the general practices. By the 12-month follow-up, GP care in some cases did include referral to mental healthcare specialists.
                The clinical outcomes included depressive symptoms, general psychiatric symptoms, social function and patient satisfaction. The economic outcomes included direct and indirect costs and quality of life. Assessments were carried out at baseline during face-to-face interviews as well as at 4 and 12 months in person or by post.
                At 4 months, both psychological therapies had reduced depressive symptoms to a significantly greater extent than usual GP care. Patients in the psychological therapy groups exhibited mean scores on the Beck Depression Inventory that were 4-5 points lower than the mean score of patients in the usual GP care group, a difference that was also clinically significant. These differences did not generalize to other measures of outcome. There was no significant difference in outcome between the two psychological therapies when they were compared directly using all 260 patients randomised to a psychological therapy by either randomised allocation method. At 12 months, the patients in all three groups had improved to the same extent. The lack of a significant difference between the treatment groups at this point resulted from greater improvement of the patients in the GP care group between the 4- and 12-month follow-ups. At 4 months, patients in both psychological therapy groups were more satisfied with their treatment than those in the usual GP care group. However, by 12 months, patients who had received non-directive counselling were more satisfied than those in either of the other two groups. There were few differences in the baseline characteristics of patients who were randomised or expressed a treatment preference, and no differences in outcome between these patients. Similar outcomes were found for patients who chose either psychological therapy. Again, there were no significant differences between the two groups at 4 or 12 months. Patients who chose counselling were more satisfied with treatment than those who chose c In a randomized, controlled trial neurotic patients (mainly phobics and obsessive-compulsives) in primary care were assigned to behavioural psychotherapy from a nurse therapist or to routine care from their general practitioner. At the end of one year clinical outcome was significantly better in patients cared for by the nurse therapist. Economic outcome to one year, compared with the year before entering the trial, showed a slight decrease in the use of resources by the nurse therapist group (N = 22), and an increase in resource usage in the GP-treated group (N = 28), mainly due to the latter's increased absence from work and more hospital treatment and drugs. On the reasonable assumptions that nurse therapists treat 46 patients a year and that such patients treated behaviourally maintain their gains for 2 years, the economic benefits to society from nurse therapists treating such patients may outweigh the costs. This excludes any monetary value on the substantial clinical gains such as reduction in fear and anxiety. However, the numbers are small, few economic differences were significant, and many patients either did not complete the trial or waiting-list periods or they failed to return economic data. Conclusions must thus be tempered with caution, even though pre-treatment demographic and clinical data of non-returners were comparable with those of returners, and though the few drop-outs who could be rated at one year had not improved. The findings cannot be extrapolated to other types of clinical problem and treatment. Common mental health problems account for up to 40% of all general practitioner (GP) consultations. Patients have limited access to evidence-based psychological therapies. Cognitive behavioural therapy self-help strategies offer one potential solution.
                To determine differences in clinical outcome, patient satisfaction and costs, between a cognitive behavioural-based self-help package facilitated by practice nurses compared to ordinary care by GPs for mild to moderate anxiety and depression.
                Randomised controlled trial.
                Seventeen primary healthcare teams.
                Patients presenting to their GP with mild to moderate anxiety and/or depression were recruited to the study and randomised to receive either a self-help intervention facilitated by practice nurses or ordinary care. The self-help intervention consisted of up to three appointments: two 1 week apart and a third 3 months later. There were no restrictions on ordinary care.
                Intention-to-treat analysis showed that patients treated with practice nurse-supported cognitive behavioural therapy self-help attained similar clinical outcomes for similar costs and were more satisfied than patients treated by GPs with ordinary care. On-treatment analysis showed patients receiving the facilitated cognitive behavioural therapy self-help were more likely to be below clinical threshold at 1 month compared to the ordinary care group (odds ratio [OR] = 3.65, 95% confidence interval [CI] = 1.87 to 4.37). This difference was less well marked at 3 months (OR = 1.36, 95% CI = 0.52 to 3.56).
                Facilitated cognitive behavioural self-help may provide a short-term cost-effective clinical benefit for patients with mild to moderate anxiety and depression. This has the potential to help primary care provide a choice of effective psychological as well as pharmacological treatments for mental health problems. We compared the efficacy of and patients' satisfaction with general-practice-based psychotherapists with those of general practitioners in providing treatment to people with emotional difficulties.
                We carried out a prospective, randomised, controlled trial of brief, non-directive psychotherapy and routine general-practice care. Therapists adhered to a non-directive Rogerian model of psychotherapy. Between one and 12 sessions of psychotherapy were given over 12 weeks in 14 general practices in north London, UK. Of 136 patients with emotional difficulties, mainly depression, 70 patients were randomly assigned to the therapist and 66 to the general practitioner. Depression, anxiety, other mental-disorder symptoms, and social adjustment were measured by self-report at baseline, 3 months, and 9 months. Patients' satisfaction was also measured by self-report at 3 and 9 months.
                All patients improved significantly over time. There were no significant differences between the groups receiving brief psychotherapy and routine general-practitioner care. Patients assigned brief psychotherapy were more satisfied with the help they received than those assigned to the general practitioner at both 3 and 9 months' follow-up (mean scores on satisfaction scale 50.9 [SD 7.9] vs 44.4 [9.8] and 45.6 [9.4] vs 37.1 [11.2], respectively).
                General-practitioner care is as effective as brief psychotherapy for patients usually referred by doctors to practice-based psychotherapists. Patients with emotional difficulties prefer brief psychotherapy from a counsellor to care from their general practitioner. To test the effects of a computer-based nursing intervention designed to provide patients and family caregivers with concrete, objective information on symptom management; provide education about disease and treatment; coordinate medical resources; and provide emotional support and counseling.
                Two-site, randomized clinical trial.
                A large, urban, midwestern, tertiary-cancer center and a community-based cancer center in a medium-sized midwestern city.
                109 patients newly diagnosed with breast, colon, or lung cancer who were receiving chemotherapy; 54 received standard care, and 55 participated in the intervention group.
                Outcome data were collected via structured telephone interviews at three time points: baseline, midway through the intervention, and one month postintervention. The intervention consisting of nine visits, five in person and four by telephone, was conducted over 18 weeks by advanced practice oncology nurses.
                Psychosocial functioning, anxiety, and depression.
                Patients who received the intervention had significantly less depression between baseline and the midway point, as well as less anxiety and greater improvement in the role-emotional and mental health subscales of the Medical Outcomes Study 36 Short Form.
                Cancer-care nursing interventions can decrease psychosocial morbidity and improve quality of life for newly diagnosed patients with cancer undergoing treatment. Additional research is needed to understand who benefited most from the intervention.
                This nurse-directed intervention resulted in improved mental health for patients; however, physical subscales were not changed. Further work is needed to determine why depression and mental health were affected yet physical health and symptoms did not differ between groups. Results support the important role of nurses in addressing mental health issues in patients and families experiencing cancer. A series of small, mainly uncontrolled, studies have suggested that techniques adapted from cognitive-behavioural therapy (CBT) for depression can improve outcome in psychosis, but no large randomised controlled trial of intensive treatment for medication-resistant symptoms of psychosis has previously been published.
                Sixty participants who each had at least one positive and distressing symptom of psychosis that was medication-resistant were randomly allocated between a CBT and standard care condition (n = 28) and a standard care only control condition (n = 32). Therapy was individualised, and lasted for nine months. Multiple assessments of outcome were used.
                Over nine months, improvement was significant only in the treatment group, who showed a 25% reduction on the BPRS. No other clinical, symptomatic or functioning measure changed significantly. Participants had a low drop-out rate from therapy (11%), and expressed high levels of satisfaction with treatment (80%). Fifty per cent of the CBT group were treatment responders (one person became worse), compared with 31% of the control group (three people became worse and another committed suicide).
                CBT for psychosis can improve overall symptomatology. The findings provide evidence that even a refractory group of clients with a long history of psychosis can engage in talking about psychotic symptoms and their meaning, and this can improve outcome. Counselling in primary care settings remains largely unevaluated. Such evaluation has been strongly recommended.
                To determine the relative effectiveness and cost-effectiveness of generic counselling and usual general practitioner (GP) care for patients with minor mental health problems.
                A randomized controlled trial and health economic evaluation were carried out in nine general practices. Access to generic counselling (brief counselling, generally involving up to six 50-minute sessions) was compared with usual GP care. A total of 162 patients aged 16 years and over with diverse mental health problems (excluding phobic conditions and psychoses) were randomized. The Hospital Anxiety and Depression (HAD) scale, COOP/WONCA (World Organization of Family Doctors) functional health assessment charts, and the delighted-terrible faces scale were used to assess outcome four months after randomization.
                The two groups were similar at baseline. There were significant improvements in both groups between randomization and follow-up for most outcome measures, but no significant differences between the study arms. The 95% confidence limits were narrow and excluded clinically significant effects. Under various assumptions concerning the cost of secondary care referrals and of counselling time, no clear cost advantage was associated with either intervention.
                This pragmatic trial demonstrates no difference in functional or mental health outcome at four months between subjects offered access to counselling and those given usual care by their GP. There is no clear difference in the cost-effectiveness of the two interventions. Purchasers should take account of these findings in allocating resources within primary care. A prospective randomized comparative study on the effectiveness of psychiatric day treatment and inpatient treatment is described. The target population consisted of patients who would normally have been admitted to an open inpatient unit. Outcome indicators were psychopathology, social functioning, interpersonal functioning, social network and social support. No differences in effectiveness were found between the two forms of treatment, although more patients accepted and completed day treatment, and day patients were more satisfied. Although a uniform treatment programme for both departments was established, distinct differences did arise in the actual treatment programme offered to the patients. The duration of treatment for the day patients was considerably longer, and the intensity of treatment was more low-key. No striking differences in the amount of medication prescribed and in the occurrence of crisis situations (including suicide) were found. Day treatment turns out to be a realistic alternative for 33% of all patients admitted for inpatient treatment. It was not possible to predict which type of patient in particular is suitable for day treatment. In two German child and adolescent psychiatric treatment and research centers, a controlled treatment study was conducted in which two randomized treatment groups (in-patient treatment and home treatment) were compared. Subjects were children and adolescents with severe psychiatric disorders, for whom normal outpatient treatment was not sufficient (mean age of the patients was 11 years and 9 months at the beginning of treatment). The results showed no differences in therapy outcome between the two treatment modalities. In a further study, the results of which are presented here, a follow-up assessment (average follow-up interval: 3 years and 8 months) of the two treatment groups (follow-up sample of the inpatient treatment group: n = 33; home treatment group: n = 35) was undertaken in order to investigate the course of the psychiatric disturbances and the long-term effects of the treatments. As measurement categories for the outcome "adaption at school" and "number of marked symptoms" were used in pre-, post- and follow-up assessment. The most important results are 1) The number of marked psychiatric symptoms and the adaptation at school or work exhibit the same type of course over time. Post-treatment scores are much better when compared to pre-treatment scores, but decline slightly upon follow-up, although they remain significantly better than the pre-treatment scores. Thus, the study shows that improvements relating to the psychiatric symptoms are quite stable after several years. 2) There were no relevant differences between the treatment modalities "inpatient treatment" and "home treatment" in terms of effect-size upon follow-up, and in inferential analysis. Any tendency towards difference was in favor of home treatment. So the results give strong support to the conclusion that at least for a specific group of patients (about 15% of those patients usually treated in an inpatient setting) residential treatment can be replaced by home treatment and that the long-term therapeutic outcome of home treatment is stable and persistent. Thus, in terms of psychiatric care and clinical practice, our results provide empirical support to the idea that home treatment should be used more frequently and much more broadly in the future. To examine the effectiveness and cost-effectiveness of short-term counselling in general practice for patients with chronic depression or combined depression and anxiety, compared with general practitioner (GP) care alone.
                A randomised controlled trial and economic evaluation with an initial assessment at randomisation and follow-ups at 6 and 12 months.
                Nine general practices that were well-established participants of the Derbyshire counselling in general practice scheme, and already had a counsellor in the practice team.
                Patients were screened at GP practices, and asked to participate if they scored >/= 14 on the Beck Depression Inventory (BDI), had suffered depression or depression/anxiety for 6 months or more, were aged 18-70 and had no history of drug or alcohol abuse, psychoses or suicidal tendencies.
                The experimental group received usual GP treatment and were also referred to an experienced, well-qualified counsellor attached to their general practice. Of the eight counsellors, two practiced cognitive behavioural therapy (CBT) and six had a psychodynamic approach. The controls were referred back to their GP for routine treatment. There were no restrictions regarding the treatment that could be used, except that GPs could not refer controls to practice counsellors.
                The main outcome measure was the BDI. Others included the Brief Symptom Inventory, the Inventory of Interpersonal Problems and the Social Adjustment Scale. All tests were given at initial, 6- and 12-month assessments. Comprehensive costs were also estimated, and combined with changes in outcomes to examine between-group differences and whether counselling was more cost-effective than standard GP care.
                The trial recruited 181 patients. There was an overall significant improvement in the actual scores over time but no difference between groups or between CBT and psychodynamic counselling approaches at either 6 or 12 months. However, fewer experimental group patients were still 'cases' on the BDI than controls. This difference was statistically significant at 12 months and neared significance at 6 months (using logistic regression with the initial score as a covariate). In addition, most patients were very positive about the counselling and considered it helpful. Visual inspection of the outcomes suggested that more patients with mild or moderate depression at study entry had improved and ceased to be cases, and that more of these patients had become 'non-cases' in the experimental than the control group. However, a multiple regression analysis indicated no significant interactions between group and initial severity of depression. This could be partly due to there being no difference in outcome between the experimental and control group patients who were initially severely depressed and few of these patients ceasing to be cases at follow-up. There were no significant differences in the mean total costs, aggregate costs of services, or any of the service-group costs, except for primary care, between the experimental and control groups over time. The cost-burden to GP practices was significantly higher in the experimental than the control group at 6 months.
                Although patients were generally appreciative of the counselling received, there was only limited evidence of improved outcomes in those referred to counselling. Stricter referral criteria to exclude the severely depressed may have yielded more conclusive results. It is also difficult to estimate the effect of recruitment by screening rather than GP referral, which may limit the applicability of the results to routine clinical practice, and may have interfered with the normal working alliance established between the GP, patient and counsellor. A patient preference trial may, therefore, have been more appropriate. The results indicated that there were similar improvements for both CBT and psychodynamic counselling, but a Both antidepressant medication and structured psychotherapy have been proven efficacious, but less than one third of people with depressive disorders receive effective levels of either treatment.
                To compare usual primary care for depression with 2 intervention programs: telephone care management and telephone care management plus telephone psychotherapy.
                Three-group randomized controlled trial with allocation concealment and blinded outcome assessment conducted between November 2000 and May 2002.
                A total of 600 patients beginning antidepressant treatment for depression were systematically sampled from 7 group-model primary care clinics; patients already receiving psychotherapy were excluded.
                Usual primary care; usual care plus a telephone care management program including at least 3 outreach calls, feedback to the treating physician, and care coordination; usual care plus care management integrated with a structured 8-session cognitive-behavioral psychotherapy program delivered by telephone.
                Blinded telephone interviews at 6 weeks, 3 months, and 6 months assessed depression severity (Hopkins Symptom Checklist Depression Scale and the Patient Health Questionnaire), patient-rated improvement, and satisfaction with treatment. Computerized administrative data examined use of antidepressant medication and outpatient visits.
                Treatment participation rates were 97% for telephone care management and 93% for telephone care management plus psychotherapy. Compared with usual care, the telephone psychotherapy intervention led to lower mean Hopkins Symptom Checklist Depression Scale depression scores (P =.02), a higher proportion of patients reporting that depression was "much improved" (80% vs 55%, P<.001), and a higher proportion of patients "very satisfied" with depression treatment (59% vs 29%, P<.001). The telephone care management program had smaller effects on patient-rated improvement (66% vs 55%, P =.04) and satisfaction (47% vs 29%, P =.001); effects on mean depression scores were not statistically significant.
                For primary care patients beginning antidepressant treatment, a telephone program integrating care management and structured cognitive-behavioral psychotherapy can significantly improve satisfaction and clinical outcomes. These findings suggest a new public health model of psychotherapy for depression including active outreach and vigorous efforts to improve access to and motivation for treatment. To compare the efficacy of antidepressant drugs and generic counselling for treating mild to moderate depression in general practice. To determine whether the outcomes were similar for patients with randomly allocated treatment and those expressing a treatment preference.
                Randomised controlled trial, with patient preference arms. Follow up at 8 weeks and 12 months and abstraction of GP case notes.
                31 general practices in Trent region.
                Patients aged 18-70 who met research diagnostic criteria for major depression; 103 patients were randomised and 220 patients were recruited to the preference arms.
                Difference in mean Beck depression inventory score; time to remission; global outcome assessed by a psychiatrist using all data sources; and research diagnostic criteria.
                At 12 months there was no difference between the mean Beck scores in the randomised arms. Combining the randomised and patient preference groups, the difference in Beck scores was 0.4 (95% confidence interval -2.7 to 3.5). Patients choosing counselling did better than those randomised to it (mean difference in Beck score 4.6, 0.0 to 9.2). There was no difference in the psychiatrist's overall assessment of outcome between any of the groups. 221/265 (83%) of participants with a known outcome had a remission. Median time to remission was shorter in the group randomised to antidepressants than the other three groups (2 months v 3 months). 33/221 (15%) patients had a relapse.
                Generic counselling seems to be as effective as antidepressant treatment for mild to moderate depressive illness, although patients receiving antidepressants may recover more quickly. General practitioners should allow patients to have their preferred treatment. To determine whether making patient-reported cancer needs, quality-of-life (QOL), and psychosocial information available to the health care team, allowing coordinated specifically targeted psychosocial interventions, resulted in reduced cancer needs, improved QOL, and increased satisfaction with care received.
                Self-reported cancer needs, QOL, and psychosocial information was collected from 450 people with cancer, using standardized questionnaires via a touch-screen computer. For a randomly chosen two thirds, this information was made available to the health care team who coordinated targeted psychosocial interventions. Information from the remaining one third was not seen. Patients were assessed 2 and 6 months after randomization for changes in their cancer needs, QOL, and psychosocial functioning and satisfaction with overall care received.
                There were no significant differences between the two arms with respect to changes in cancer needs, QOL, or psychosocial functioning between the baseline and follow-up assessments, nor with respect to satisfaction with care. However, for the subgroup of patients who were moderately or severely depressed at baseline, there was a significant reduction in depression for the intervention arm relative to the control arm at the 6-month assessment (P =.001).
                Making patient-reported cancer needs, QOL, and psychosocial data available to the health care team at a single consultation together with coordinated psychosocial interventions does not seem to reduce cancer needs nor improve QOL, psychosocial functioning, or satisfaction with the care received. However, identification of patients with moderate or severe levels of depression may be valuable in reducing subsequent levels of depression. We test the hypotheses that (a) cognitive therapy is of comparable efficacy to psychodynamic psychotherapy, (b) 8-10 sessions of therapy is as effective as 16-20 sessions, and (c) brief therapist training is as effective as intensive training.
                Of 178 out-patients referred to a clinical trial of psychological treatment for generalised anxiety, 110 patients met DSM-III-R criteria for generalised anxiety disorder and were randomly assigned to three different forms of psychotherapy. The main comparison was between cognitive therapy and analytic psychotherapy, delivered by experienced therapists at weekly or fortnightly intervals over six months. A third treatment, anxiety management training, was delivered at fortnightly intervals by registrars in psychiatry after a brief period of training. Eighty patients completed treatment and were assessed before treatment, after treatment, and at six-month follow-up.
                Cognitive therapy was significantly more effective than analytic psychotherapy, with about 50% of patients considerably better at follow-up. Analytic psychotherapy gave significant improvement but to a lesser degree than cognitive therapy. There was no significant effect for level of contact. Patients receiving anxiety management training showed similar improvements to cognitive therapy after treatment, with rather lower proportions showing clinically significant change.
                Cognitive therapy is likely to be more effective than psychodynamic psychotherapy with chronically anxious patients. Significant improvements in symptoms can be achieved by trainee psychiatrists after only brief instruction in behaviourally based anxiety management. However, the superiority of cognitive therapy at follow-up suggests that the greater investment of resources required for this approach is likely to pay off in terms of more sustained improvement. There is no evidence that 16-20 sessions of treatment is more effective, on average, than 8-10 sessions.
There are insufficient data to identify a difference in outcome between supportive therapy and standard care. There are several outcomes, including hospitalisation and general mental state, indicating advantages for other psychological therapies over supportive therapy but these findings are based on a few small studies. 
Future research would benefit from larger trials that use supportive therapy as the main treatment arm rather than the comparator.