آموزش روانی برای افسردگی اساسی: مطالعه کنترل شده تصادفی

Abstract Various psychological therapies have been shown to be effective for the treatment of mood disorders. Among them, family psychoeducation has demonstrated efficacy in reducing symptom severity and extending the time to relapse. We tested the efficacy of adding psychoeducation focussed on how to deal with the family's expressed emotion to treatment as usual (TAU) to prevent relapse among patients with remitted major depression. A total of 34 patients with major depressive disorders in full or partial remission were randomised to receive either group psychoeducation over six sessions, each consisting of a didactic lecture and group problem-solving (n=19), plus TAU or TAU alone (n=15). The primary outcome was relapse by Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM–IV) criteria. Masked raters administered the Hamilton Rating Scale for Depression-17 (HRSD-17). As many as 18 patients in the intervention group and 14 patients in the control group completed the study. Time to relapse was significantly longer in the intervention group than in the control group, with a risk ratio (RR) of relapse by 9 months of 0.12. At 9 months, there was a significantly greater decrease in the HRSD-17 score in the intervention group than in the control group. We demonstrated the effectiveness of patient psychoeducation on the course and outcome of major depressive disorders.

1. Introduction Psychoeducation has demonstrated effectiveness for patients with depression as a first step in the treatment protocol in the NICE guidelines (National Institute for Health and Clinical Excellence, 2009), especially when used together with medication. Psychoeducational approaches to patients with schizophrenia and their families have developed partly based on studies of expressed emotion (EE) in the family (Brown et al., 1972 and Vaughn and Leff, 1976). High-EE status in the family has been shown to be a risk factor for relapses of schizophrenia (Bebbington and Kuipers, 1994). Since 1982, studies on family intervention using EE as a target have shown the effects of psychoeducational family intervention for preventing relapses (Falloon et al., 1982, Tarrier et al., 1988 and Shimodera et al., 2000). There have been a variety of psychological therapies demonstrated to be effective for the treatment of mood disorders (Hollon and Ponniah, 2010). Among them, psychoeducation is widely accepted as it fits very well with the medical model of illness by being a clinically focussed, commonsense-based intervention (Colom, 2011). Moreover, it is relatively simple and can be administered by therapists of various disciplines without extensive training. Most of the research on psychoeducation for patients with mood disorders has been conducted with bipolar disorders. Colom and his colleagues (2003) investigated the effects of group psychoeducation for those with bipolar I and II disorders on the course of the disorders and showed that group psychoeducation significantly reduced the number of relapsed patients and the number of recurrences per patient. Colom and his colleagues (2009) also explored the efficacy of group psychoeducation for those with bipolar II disorders only and showed that psychoeducation plus medication significantly decreased the number of episodes and days spent in mood episodes and increased levels of functioning. Research has demonstrated the effects of family psychoeducation on the course of bipolar disorders. Compared to the control group, the family psychoeducation group showed less experience of any mood recurrence and longer relapse-free intervals (Miklowitz et al., 2003). Psychoeducation for patient–companion dyads has also been applied and has shown its effects on the course of bipolar disorders by reducing the number of relapses and the time to relapse (D'Souza et al., 2010). In the case of major depressive disorder (MDD), interpersonal therapy, cognitive behavioural therapy and behavioural therapy have vast empirical support through many randomised controlled trials demonstrating their efficacy (APA, 2004). The mainstream psychoeducational intervention for patients with depression is the ‘Coping with Depression’ (CWD) course, which is a cognitive behavioural intervention that treats and prevents depression in many target populations by providing them with instructions on how to cope with their psychological symptoms themselves (Lewinsohn (1975); Cuijpers et al., 2009). However, most of the studies using CWD are on complex target groups because of its flexibility, leading to low mean effect sizes (Cuijpers et al., 2009). The intervention itself is complex and requires eight to 16 sessions. Still, group psychoeducation for MDD can be effective (Colom, 2011). Donker et al. did a meta-analysis of psychoeducation for depression and anxiety (Donker et al., 2009). This meta-analysis revealed that brief passive psychoeducational interventions for depression and psychological distress can reduce symptoms (Donker et al., 2009). However, all the above-referenced psychoeducations are focussed on how to cope with their symptoms and none of them tried to focus on how to cope with their overcomplicated relationship due to depression. There have also been a number of reports describing an association between EE and relapse of depression (Hooley et al., 1986, Okasha et al., 1994, Mino et al., 2000 and Mino et al., 2001). Our prospective study suggested that the association of EE with relapse might be even stronger in depression than in schizophrenia (Mino et al., 2001). In fact, we conducted family psychoeducation which sets a goal of reducing the family's EE for members with major depression and found that the time to relapse was much longer in the intervention group than in the control group (Shimazu et al., 2011). The family psychoeducation programme tested was simple and consisted of only four sessions of didactic lectures and group problem-solving exercises (Shimazu et al., 2011). Inspired by these encouraging results, we planned to provide persons with MDDs with a similar frame of psychoeducation without their family and to examine its influence on the course and outcome of the illness. Thus, the aim of this study was to test for patients with MDDs the effectiveness of simple psychoeducation which is focussed on how to cope with family members and colleagues and superiors at the workplace in a randomised controlled design.

3. Results Of the 34 patients randomly allocated to the intervention and control groups, one patient in the intervention group and one patient in the control group withdrew their consent before actually entering the study, resulting in 32 patients who entered the study, with 18 in the intervention group and 14 in the control group. During the study period, one patient in the intervention group dropped out and four patients in the control group changed hospitals. Follow-up data at 9 months for these five patients were not available, but we will focus on these 32 patients as our intention-to-treat sample, with the dropouts treated as censored cases as appropriate (Fig. 1). Flow of participants through the trial. Fig. 1. Flow of participants through the trial. Figure options The 32 participants who entered the study had a mean age of 42.8, mean duration of illness of 36.8 months, mean number of previous admissions of 0.3, mean HRSD-17 score of 11.4 and mean antidepressant dose of 125.7 mg (amitriptyline equivalent). In short, the majority of subjects were in their middle age and in a mildly depressive state. Comparison of the variables between the two groups showed no significant differences regarding demographic variables such as sex, age, education, living conditions (i.e., living with family/others or living alone), time from home to the hospital and clinical variables such as duration of illness, baseline HRSD-17, BDI-II, CGI severity or GAF scores (Table 1). Table 1. Baseline characteristics of the experimental and control groups. Intervention (N=18) Control (N=14) Gender: Male/Female 6/12 8/6 ns (chi-squared p=0.178) Age (years): Mean(SD) 44.8 (12.0) 40.3 (9.3) ns (t test p=0.251) Time from home to hospital (minutes); Mean(SD) 26.0 (13.0) 31.3 (24.4) ns (t test p=0.437) Education; n(%) Graduation from junior high school 1 (6) 0 (0) ns (chi-squared p=0.364) Graduation from senior high school 4 (22) 7 (50) Graduation from junior college 7 (39) 4 (29) Graduation from university 6 (33) 3 (21) Living conditions; n Lives with family or others/Lives alone 15/2 11/2 ns (Fisher p=1.000) Duration of illness (m): Mean(SD) 37.3 (45.2) 35.9 (24.2) ns (t test p=0.921) Number of admission: Mean (SD) 0.2 (0.5) 0.4 (0.6) ns (t test p=0.226) HRDS: Mean(SD) 12.4 (5.5) 10.0 (5.3) ns (t test p=0.336) BDI-II: Mean(SD) 24.1 (12.0) 19.9 (9.4) ns (t test p=0.305) CGI severity: Mean(SD) 3.3 (0.6) 2.9 (0.8) ns (t test p=0.057) GAF: Mean(SD) 56.3 (11.2) 60.6 (13.0) ns (t test p=0.323) Dose of antidepressant(s) (mg): Mean(SD) (amitryptiline equivalent) 108.1 (51.2) 148.3 (71.0) ns (t test p=0.072) Table options 3.1. Adherence Out of the 17 patients in the intervention group, 13 patients (76%) received the full six sessions, three received five sessions and one patient received only one session; she dropped out after finishing the first session but revisited the hospital and follow-up assessment was obtained. 3.2. Relapse In the intention-to-treat analysis, relapse occurred in one patient (6%) in the intervention group and in five patients (36%) in the control group. The mean (standard deviation, S.D.) HRSD-17 and BDI-II scores at relapse were 25.0 (4.1) and 33.3 (6.1), respectively. Kaplan–Meier survival analysis showed that time to relapse was significantly longer in the intervention group than in the control group (Log-rank chi-squared=6.48, df=1, P=0.011) ( Fig. 2). The median time to relapse was 274 days for the intervention group and 221 days for the control group. The crude risk ratio of relapse by 9 months was 0.12 (95% confidence interval (CI); 0.02–0.87, P=0.015), corresponding with a number needed to treat (NNT) of 3.2 (95%CI: 2.8–21.4). Time to relapse by treatment group. Fig. 2. Time to relapse by treatment group. Figure options In order to control for possible confounders, we conducted Cox proportional hazard analysis by entering sex, age, illness duration, baseline HRSD-17 score, baseline antidepressant dosage and intervention; only intervention emerged as a significant predictor of the time to relapse (hazard ratio, HR=0.091, 95%CI: 0.01–0.87, P=0.038) ( Table 2). There were no significant differences between relapsers and non-relapsers in terms of other variables such as sex, age, education, living conditions, baseline HRSD-17, BDI-II scores and baseline dose of antidepressant(s). Table 2. Cox proportional hazard analysis adjusting for baseline variables. B SE p Exp(B) 95% CI Intervention −2.39 1.15 0.038 0.091 0.010–0.87 Gender −0.69 0.92 0.45 0.50 0.83–3.03 Age 0.01 0.05 0.85 1.01 0.92–1.11 Duration of illness −0.03 0.03 0.28 0.97 0.92–1.03 Antidepressant dosage −0.01 0.01 0.50 0.99 0.98–1.01 Baseline HRSD −0.04 0.11 0.73 0.96 0.77–1.2 Table options 3.3. Nine-month outcome Nine-month outcomes were examined among the 27 patients who could be followed up. Follow-up HRSD-17, BDI-II, CGI severity and GAF were compared between the intervention and control groups to evaluate the effects of psychoeducation at 9 months using analysis of covariance (ANCOVA) with respective baseline scores as a covariate (Table 3). All the HRSD-17, the BDI-II, the CGI severity and the GAF scores were statistically significantly better in the intervention group than in the control group while controlling for their respective baseline scores. The CGI-improvement score was also significantly better in the psychoeducation group. Table 3. The treatment of data of the intervention and control groups. Intervention group (N=17) Control group (N=10) ANCOVA Sensitivity analyses Baseline Nine months Baseline Nine months p p HRSD: Mean(SD) 12.4 (5.7) 6.5 (5.3) 10.6 (5.0) 15.0 (8.5) 0.002 0.004 BDI-II: Mean(SD) 23.9 (12.3) 10.4 (10.1) 19.0 (10.7) 21.8 (12.2) 0.008 0.002 CGI-severity: Mean(SD) 3.35 (0.61) 2.47 (0.94) 3.00 (0.67) 3.40 (1.07) 0.035 0.049 CGI-improvement: Mean (SD) – 2.12 (1.11) – 4.20 (1.48) <0.001 – GAF: Mean(SD) 56.0 (11.4) 77.1 (12.4) 60.9 (11.7) 61.6 (18.0) 0.02 0.007 Table options Sensitivity analyses were conducted by substituting the missing 9-month follow-up data for HRSD-17, BDI-II, CGI severity and GAF by their baseline values. Again, all the scores were significantly better in the intervention group than the control group (Table 3). The rate of remitted patients in the intervention group was 10 out of 17 (58.8%) and that in the control group was two out of 10 (20.0%), indicating no significant difference between the two groups (Fisher's exact test; P=0.110). 3.4. Drug treatment variables Among the completers, the baseline dose of antidepressant tended to be higher in the control group but was not significantly different between the intervention and the control groups (mean (S.D.) amitriptyline equivalent dose of 107.5 (52.8) vs. 134.0 (71.5) mg; t=1.89, P=0.072). Entering this variable in the Cox proportional hazard analysis, however, did not change the results. Neither were the types of antidepressants (i.e., newer-generation antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) vs. older-generation antidepressants including tricyclic antidepressants (TCAs)) significantly different between the two groups. At 9 months, the mean (S.D.) dose of antidepressant in the intervention group was 102.7 (59.2) mg and that in the control group 124.0 (57.1) mg, showing again no difference between the groups (F=0.079, P=0.78).