Brief dynamic therapy and depression severity: A single-blind, randomized study Gianluca Rosso, Barbara Martini, Giuseppe Maina,
Abstract Background
Brief dynamic therapy (BDT) has been shown to be effective in treating depressive disorders. Nevertheless, whether its effect is related to the severity of depression is still unknown. The aim of this study was to analyze whether the efficacy of BDT is related to severity of depressive symptoms in patients with mild to moderate unipolar depressive disorders.
Methods
A randomized clinical trial compared BDT with brief supportive psychotherapy (BSP) in 88 outpatients with depressive disorders. Two subgroups of patients were considered for statistical analysis: with mild depressive disorders (HAM-D17 baseline score: 8–13) and with moderate depressive disorders (HAM-D17 baseline score: 14–18). Patients were assessed at start of treatment (baseline-T0), at the end of treatment (T1) and at 6-month follow-up (T2).
Results
In the subgroup of patients with mild depressive disorders, no statistically significant differences emerged between the two treatments on all efficacy measures. In the subgroup of patients with moderate depressive disorders, the remission rates of patients treated with BDT were higher than those of patients treated with BSP at 6 month of follow-up (90.5% vs. 34.8%: p<.005).
Limitations
The sample size was relatively small; a longer follow-up period should be considered to assess the efficacy of BDT in terms of prevention of recurrences.
Conclusions
The efficacy of BDT in treating depressive disorders is higher in moderate than in mild depression. Keywords
Depressive disorders; Brief dynamic therapy; Supportive psychotherapy; Psychotherapy; Depression severity 1.Background
A recent meta-analysis investigating the efficacy of specific psychotherapeutic techniques in depression (Driessen et al., 2010a) underlies that when different types of psychotherapies prove to be superior to nonspecific controls (whether pill-placebos or nonspecific psychotherapy controls) such differences are only apparent among more severely depressed patients. These results suggest that nonspecific processes may be sufficient to produce change among patients with less severe depressions but that specific techniques may be required for patients with more severe depressions (Hollon and Ponniah, 2010).
Among the specific models of short-term psychotherapies, the brief dynamic therapy (BDT) is becoming more important and has made significant contributions in the treatment of depressive disorders giving a particular care to evaluation of results and applicability in public health services (Driessen et al., 2010a, Churchill et al., 2001, Salminen et al., 2008, Cuijpers et al., 2008, Imel et al., 2008, Rosso et al., 2009, Abbass et al., 2011 and Bloch et al., 2012).
Recent studies suggest that BDT is an effective psychological treatment that works also after the end of treatment sessions (Abbass and Driessen, 2010 and Driessen et al., 2010b). In comparison with non-specific supportive psychotherapies, for patients treated with BDT a significant advantage was found in
post-treatment observations (Maina et al., 2005). Similarly, some studies evidenced that the benefit of adding BDT to medication in the acute treatment of major depressive disorder is significantly higher over a subsequent six-month continuation phase (Abbass, 2006 and Maina et al., 2007). Moreover, patients treated with BDT combined with pharmacotherapy during their first major depressive episode seem less likely to experience a recurrence over a subsequent 48-month treatment-free follow-up (Maina et al., 2009). Further understanding of how depression responds to brief dynamic therapy is important to direct treatment strategies. Up to now, there have been no studies examining whether the effect of BDT is related to severity of depressive symptoms. This was the purpose of our study.
2. Methods 2.1. Sample
Subjects were recruited from the outpatient waiting list for BDT at the Mood and Anxiety Disorders Unit, Department of Neuroscience of the University of Turin, Italy. The criteria used for being included in the BDT waiting list were (a) patients requesting a psychotherapeutic approach, (b) the presence of a focal problem and/or of a recent precipitant life event – as suggested by Malan (1963), (1976) and (Horowitz et al. (1997) – and (c) age 18–65 years. Exclusion criteria were (a) evidence of mental retardation, lifetime history of organic mental disorders, psychotic disorders, bipolar disorders or substance abuse and (b) severe axis II psychopathology (cluster A personality disorders, antisocial personality disorder and borderline personality disorder according to DSM-IV-TR).
Patients recruited from the BDT waiting list for the present study had also to fulfil the three following inclusion criteria: (1) main diagnosis of depressive disorder (major depressive disorder, dysthymic disorder, depressive disorder NOS, adjustment disorder with depressed mood) according to DSM-IV-TR; (2) a baseline score on the 17-item Hamilton Rating Scale for Depression (HAM-D17)>7 and <19 according to the American Psychiatric Association’s Handbook of Psychiatric Measures which defines mild depression as HAM-D scores from 8 to 13 and moderate depression from 14 to 18 (Rush et al., 2008 and Fournier et al., 2010); (3) written informed consent. Further, additional exclusion criteria for the investigation were: (1) current psychopharmacological drug treatment, (2) suicide risk evaluated as item 3 of the HAM-D17>2 and/or on the basis of the clinical judgment, (3) concomitant severe or active neurological or physical disease. The protocol was approved by the local Ethical Committee.
Two hundred and forty-four subjects of the waiting list were screened consecutively for the inclusion in this study: 156 were excluded (27 with main diagnosis other than depressive disorder, 24 with HAM-D17 score ≥19, 103 already in treatment with antidepressant pharmacotherapy, 2 for concomitant severe physical disease) and 88 were considered because they fulfilled the requirements.
2.2. Procedure
A randomized parallel-group design was addressed to estimate the relative benefit of BDT over a non-specific supportive intervention (brief supportive psychotherapy—BSP) in patients with unipolar depressive disorders, across a range of initial symptom severity. Patients were allocated randomly to BDT or BSP by the study recruiter, who drew one of two coloured balls from a bag, the assignment of each therapy to a different coloured ball having been defined at the start of the study and maintained until the end of the recruitment period.
The trial was preceded by a 2-week period in which the diagnosis was assessed by means of the Structured Clinical Interview for DSM-IV axis I and II disorders (First et al., 1997a and First et al., 1997b), the inclusion and exclusion criteria were checked. At the end of the acute treatment phase with BDT or BSP, the patients entered in a 6-month follow-up period.
Patients were treated by psychotherapists (psychiatrists, psychologists, or advanced supervised resident in psychiatry or clinical psychology).
2.3. Treatments
Brief Dynamic Therapy: the primary objective of BDT is to enhance the patient’s insight into repetitive conflicts (intrapsychic and interpersonal) and trauma that underlie and sustain the patient’s problems. The principal instruments of BDT are interpretation and clarification. The psychotherapeutic technique we apply in our Department as BDT derives from Malan’s focused, short-term psychoanalytic psychotherapy (Malan, 1976). According to this model the therapist makes use of the actual relationship and attends to linkages with past significant relationships. In addition, to enhance insight, this psychotherapy provides a corrective emotional experience in which old and current traumas, “shameful” secrets and other warded off feelings and memories are brought to light and expressed in presence of the therapist. This kind of technique is supported by meta-analysis (Diener et al., 2007 and Abbass et al., 2009) that found emotion focused brief dynamic therapies outperform more than insight based short term therapy models. An experienced BDT therapist who reviewed case notes and supervised treatment adherence according to manuals weekly monitored each BDT therapist (Horowitz et al., 1997, Malan, 1963 and Malan, 1976).
Brief Supportive Psychotherapy: the primary objective of supportive therapy is to improve the patient’s immediate adaptation to his/her life situation. Principal instruments are reassurance and encouragement and the treatment involves advice, praise and emphasis on strengths and talents. The treatment adherence of therapists was facilitated by strict compliance with manuals (Novalis et al., 1993).
In both therapies patients were told from the outset that their treatment would be time-limited with a number of sessions ranging from 15 to 30.
The principles of the technique of BDT and BSP have been already detailed in our previous works on this topic (Maina et al., 2005 and Maina et al., 2007).
2.4. Clinical assessment
The primary outcome measure employed was the HAM-D17. Moreover, patients were assessed by the Clinical Global Impression for Severity (CGI-S), Hamilton Rating Scale for Anxiety (HAM-A) and Sheehan Disability Scale (SDS).
Patients assigned to the two treatment strategies were assessed at the start of the treatment [time 0 (T0): baseline], at the end of the treatment [time 1 (T1)] and at the end of the 6-month follow-up phase [time 2 (T2)]. In addition, all patients were informed to contact their psychiatrist every time they experienced a worsening of symptoms; in this case, another evaluation was conducted by the same rating scales.
Two raters assessed all patients: they were 2 psychiatrists who did not participate in the study as therapists and were kept blind with respect to the treatment assignment. The patients were advised not to talk to the evaluators about the type of psychotherapy they were undergoing. In the early phase of the study, interrater agreement on the diagnosis as well as the classification regarding the clinical features of major depressive disorder were ascertained.
The interrater reliability of DSM-IV diagnosis was good (k=0.79, 95% confidence interval=0.71–0.87). To determine the interrater reliability, the two raters simultaneously assessed 10 depressed subjects before the start of this study; the score obtained by our raters on HAM-D17 correlated above 0.90.
2.5. Statistical analyses
All statistical analyses were performed by SPSS software version 17.0. The results of the statistical comparisons of the treatment groups were presented as two-sided p-values rounded off to 3 decimal places. The criterion for statistical significance in all comparisons was a p-value<0.050.
Analysis of variance was performed to test the comparability of continuous variables (index age and educational level) and to test intergroup differences in rating scale scores (HAM-D17, HAM-A, CGI, SDS). Pearson’s χ2 calculations were used to compare sex ratio, marital status and occupational status among the groups. Pearson’s χ2 calculations (two-sided; p<0.05) were also used to compare the outcome measure of the qualitative evaluation: HAM-D17 remission (HAM-D17 score of 7 points or less).
The data analysis method used for outcome measures was performed on the ‘intent to treat (ITT)’ sample, which consisted of all those patients who where allocated to treatment after randomization. For missing values a “last observation carried forward” approach was applied.
First, in order to compare the efficacy of BDT and BSP, the analysis was performed in the total sample. Then, to evaluate the correlation between treatment’s efficacy and severity of depressive symptoms, the comparison between BDT and BSP has been repeated considering two distinct subgroups of patients according to the APA Handbook of Psychiatric Measures (Rush et al., 2008): (1) with mild depressive disorders (baseline HAM-D17 score: 8–13) and (2) with moderate depressive disorders (baseline HAM-D17 score: 14–18).
To define the sample size of the subgroups we used the formula for minimum sample size related to the comparison of means (in particular we considered the HAM-D17 means) (Kirkwood and Sterne, 2006), given a statistical power of 90%; thus, the size of each subgroup had to be at least 11 patients.
3. Results
The ITT efficacy patient sample consisted of 88 patients: 16 (18.2%) were affected by major depressive disorder, 8 (9.1%) by dysthymic disorder, 13 (14.8%) by depressive disorder NOS, 51 (57.9%) by adjustment disorder with depressed mood. The characteristics of the ITT sample are given in Table 1. No statistically significant differences were found between the two treatment groups in demographic characteristics or baseline rates. Moreover BDT and BSP did not differ in number of sessions and duration of treatment.
Table 1.
Socio-demographic and clinical characteristics of patients with depressive disorders in the two treatment groups at baseline (intent-to-treat sample).
BSP(n=55) BDT(n=33) Analysis χ2/F d.f. p Sex,N(%) 0.324 1 0.640 Males 18 (32.1) 9 (26.5) Females 38 (67.9) 25 (73.5)
Age, years, mean (±s.d.) 41.7±13.33 36.6±11.89 0.999 86 0.070
Marital status,N(%) 3.993 3 0.262
Married 27 (49.1%) 15 (45.5%)
Divorced 6 (10.9%) 1 (3.0%)
Never married 20 (36.4%) 17 (51.5%)
Widover/widow 2 (3.6%) 0 (0%)
Educational level, years, mean (±s.d.) 13.4±3.26 14.7±3.81 1.989 86 1.101
Working for pay,N(%) 1.397 1 0.345
Yes 35 (63.6) 25 (75.8)
No 20 (36.4) 8 (24.2)
Main diagnosis,N(%) 7.003 3 0.720
Major depressive disorder 6 (10.9) 10 (30.3)
BSP(n=55) BDT(n=33)
Analysis χ2/F d.f. p Depressive disorder NOS 8 (14.5) 5 (15.2)
Adjustment disorder with depressed mood 37 (67.3%) 14 (42.4) Baseline scores of rating scales, mean (±s.d.)
HAM-D 13.25±3.46 14.12±3.91 0.795 86 0.282 HAM-A 11.62±5.04 11.61±4.05 1.123 86 0.991 CGIs 3.44±0.60 3.61±0.50 1.760 86 0.176 SDS—work 5.20±1.30 5.88±1.90 7.531 86 0.072 SDS—social 5.42±1.39 5.88±1.41 0.256 86 0.137 SDS—family 5.82±1.20 6.27±1.35 0.586 86 0.105
Psychotherapy duration (months) 6.39±3.97 5.52±2.05 12.521 85 0.181 Psychotherapy duration (number of sessions) 16.94±11.32 18.61±6.74 8.133 85 0.393 The dropout rate was 29.1% (n=16) in BSP group, and 18.2% (n=6) in the BDT group (difference not statistically significant). All dropouts were due to the fact that a patient stopped attending the psychotherapy sessions (two consecutive sessions or more than two non-consecutive sessions). All withdrawals from the study were within T1 (end of treatment).
In the total ITT sample, the comparison between BDT and BSP did not show any significant differences at the end of treatment (T1); nevertheless, at 6-month of follow-up (T2) a statistically significant improvement in BDT group emerged on all rating scales; moreover at T2 we found that treatment with BDT was associated with a significantly higher proportion of patients that reached HAM-D17 remission, (respectively 75.8% and 47.3% in the BDT and BSP groups; χ2: 6.868; p=.008).
The statistical analyses have been further conducted on two distinct subgroups considering depression severity: patients with mild depressive disorders (N=44) and patients with moderate depressive disorders (N=44). Table 2 shows the comparison of BDT and BSP efficacy (mean scores of rating scales) in the two samples (LOCF analyses): statistically significant differences emerged in favour of BDT at T1 (HAM-D17 and HAM-A) and at T2 (all rating scales) in the subgroup of patients with moderate depressive symptoms; no significant differences have been found at any assessment points in the subgroup of patients with mild depressive symptoms.
Table 2.
Comparison between the efficacy of BDT and BSP in the treatment of mild and moderate depressive disorders: mean HAM-D, HAM-A, CGI-S and Sheehan scores.
BSP (n=32) BDT (n=12)
Analysis
F d.f P
Mild depressive disorders (HAM-D>7<13) HAM-D-17 score Baseline (T0) 10.63±1.68 9.50±1.57 0.422 42 0.051 End of treatment (T1) 6.53±3.89 5.92±3.80 0.731 42 0.641 6-month FU 6.97±4.08 5.00±4.59 0.700 42 0.175 HAM-A score Baseline (T0) 10.03±2.99 8.17±3.49 0.139 42 0.085 End of treatment (T1) 5.94±3.31 5.33±3.77 0.007 41 0.609 6-month FU (T2) 6.29±3.39 4.42±4.46 2.119 41 0.145
BSP (n=32) BDT (n=12) Analysis F d.f P CGI-S score Baseline (T0) 3.09±0.30 3.17±0.39 1.682 42 0.509 End of treatment (T1) 2.13±0.83 2.25±1.14 2.622 42 0.691 6-month FU (T2) 2.25±0.84 2.08±1.24 6.614 42 0.673 Sheehan score—work Baseline (T0) 4.59±0.80 4.83±1.95 12.587 42 0.686 End of treatment (T1) 3.13±1.22 3.17±2.89 15.474 40 0.970 6-month FU (T2) 3.13±1.31 2.75±2.96 15.320 40 0.383 Sheehan score—social Baseline (T0) 4.78±1.21 4.83±1.27 0.005 42 0.903 End of treatment (T1) 3.50±1.83 3.25±2.42 0.831 40 0.751 6-month FU (T2) 3.53±1.83 2.75±2.67 4.548 40 0.365 Sheehan score—family Baseline (T0) 5.47±1.22 5.33±1.16 0.354 42 0.741 End of treatment (T1) 3.80±2.30 3.33±2.28 0.005 40 0.554 6-month FU (T2) 3.90±2.35 2.75±2.73 1.418 40 0.180 BSP (n=23) BDT (n=21) Analysis F d.f. P
Moderate depressive disorders HAM-D≥13<19 HAM-D-17 score Baseline (T0) 16.91±1.20 16.76±1.73 7.545 42 0.741 End of treatment (T1) 10.70±5.46 8.00±3.05 6.366 42 0.048 6-month FU 10.26±5.54 4.33±3.32 7.032 42 <0.001 HAM-A score Baseline (T0) 13.83±6.40 13.57±2.90 9.967 42 0.864 End of treatment (T1) 9.13±5.10 6.10±2.38 25.828 42 0.015 6-month FU (T2) 8.13±4.52 3.76±2.86 5.871 42 <0.001 CGI-S score Baseline (T0) 3.91±0.60 3.86±0.36 1.934 42 0.706 End of treatment (T1) 2.52±1.20 1.90±0.94 3.462 42 0.067 6-month FU (T2) 2.39±1.20 1.33±0.80 11.081 41 0.001 Sheehan score—work Baseline (T0) 6.04±1.40 6.48±1.57 1.815 42 0.339 End of treatment (T1) 3.91±1.48 3.24±1.45 0.111 42 0.133 6-month FU (T2) 4.00±1.60 1.52±1.44 0.241 42 <0.001 Sheehan score—social Baseline (T0) 6.30±1.10 6.48±1.12 0.000 42 0.612 End of treatment (T1) 4.22±1.31 3.67±1.43 0.058 42 0.189 6-month FU (T2) 3.78±1.62 1.90±1.61 0.563 42 <0.001 Sheehan score—family Baseline (T0) 6.30±1.02 6.81±1.17 0.525 42 0.133 End of treatment (T1) 3.96±1.46 3.57±1.21 1.611 42 0.349 6-month FU (T2) 3.91±1.68 1.71±1.52 0.111 42 <0.001
The rates of the HAM-D17 remission are resumed in Table 3: in the subgroup of patients with mild depressive disorders, about 60% of patients reached remission both at T1 and T2 without differences between BDT and BSP; in the subgroup of moderate depressive disorders, the remission rates of patients treated with BDT were higher than those of patients treated with BSP at 6 month of follow-up (90.5% vs. 34.8%: p<.002).
Table 3.
HAM-D17 remission rates (%): comparison between BDT and BSP in mild and moderate depressive
symptoms.
BSP BDT
Analysis χ2 d.f. p HAM-D17remission rates (%)
Patients with mild depressive disorders End of treatment (T1) 62.5 58.3 0.064 1 0.800 6-month FU (T2) 59.4 58.3 0.004 1 0.950 Patients with moderate depressive
disorders End of treatment (T1) 26.16-month FU (T2) 34.8 47.690.5 2.1999.204 11 0.1380.002 4. Discussion
This study addresses the pragmatic question of the efficacy of brief dynamic therapy in depressive disorders in correlation with symptoms severity. Specifically, we examined whether greater severity of depressive symptoms at prerandomization leads to a higher symptoms reduction with brief dynamic therapy and to a lower symptoms reduction with a nonspecific psychotherapeutic intervention.
In agreement with our previous findings (Maina et al., 2005 and Maina et al., 2009) this study shows the significant positive effect of BDT in the treatment of unipolar depressive disorders; in addition, these data also highlight the stronger effects in patients with moderate depression at six-month follow-up. Actually, our results show that BDT has better efficacy in the treatment of moderate depression than in mild depression in comparison with a supportive psychotherapy intervention. Patients with moderate depression treated with BDT gain more benefit over the subsequent six-month post-treatment phase on a number of efficacy measures. Improvements for moderate depressive disorders are also more marked when the remission rates have been considered: BDT and supportive psychotherapy exhibite similar efficacy in mild depression, but remission rates in moderate depressions are significantly higher for BDT than for BSP (90.5% of remission at follow-up compared with 34.8%).
These findings are consistent with the recent meta-analysis of (Driessen et al. (2010b)) which concludes that nonspecific processes may be sufficient to produce change among patients with less severe depressions but specific techniques may be required for patients with more severe depressions. On the other hand, these data are also in accordance with (Fournier et al., 2010) who pointed-out in their recent meta-analysis on antidepressant drugs effect and depression severity that the magnitude of benefit compared with placebo increases with symptoms severity and may be minimal or non-existent in patients with milder symptoms. In conclusion, this study suggests that the benefit of BDT in treating depressive symptoms and improving the outcome of unipolar depressive disorders is stronger in moderate than in mild depression.
These results, if confirmed by other studies conducted in larger sample sizes and with longer follow-up periods, could have important implications in terms of cost-effectiveness. Indeed BDT therapists (who receive a more expensive and specific training), could be addressed to treat patients with moderate depression, while patients with mild depressive disorders could equally benefit of a less expensive psychotherapy, such as BSP.
Moreover, although there is not a statistically significant difference, BDT showed less dropouts than BSP (18.2% vs. 29.1%). This datum, even if cautiously, could be considered as a further possible advantage of BDT, especially in patients with moderate depressive disorders. As previously pointed-out through a structured interview administered to patients at the end of psychotherapy (Maina et al., 2007), a possible reason of lower dropout rate is that a half of patients treated with BDT answered that the therapy is “extremely helpful”, in comparison to a minority of patients treated with BSP.
Finally, our opinion about the reason why BDT is more effective in time is that the primary objectives of BDT (which are to enhance the patient’s insight into repetitive conflicts and trauma and to provide a corrective emotional experience) is a specific therapeutic factor: it sustains the patient’s improvements not only during the treatment sessions, but also during the follow-up period. In particular, as suggested by Diener et al. (2007) facilitating patient affect for promoting change in short term dynamic therapy could represent a step toward delineating specific interventions that are related to outcome. The change in patient affect and emotional experience could be a crucial factor in enhancing reduction of depressive symptoms especially during the follow-up period.
5. Limitations
The results of this study are limited by the relatively small sample size. A larger size would allow researchers to confirm these findings with stronger statistical power. Further, a longer follow-up period should be considered to assess the efficacy of BDT in terms of prevention of recurrences.
The exclusion of patients with severe depressive disorders could represent a further limitation; this was due to ethical reason: according to APA guidelines for the treatment of patients with major depressive disorder (Gelenberg et al., 2010) the use of a depression focused psychotherapy alone is recommended as an initial treatment choice for patients with mild to moderate depressive disorders only.
Conflict of interest
All other authors declare that they have no conflicts of interest.
Contributors
Giuseppe Maina designed the study and wrote the protocol. Barbara Martini managed the literature searches and analyses. Gianluca Rosso and Barbara Martini undertook the statistical analysis, and author Gianluca Rosso wrote the first draft of the manuscript. All authors contributed to and have approved the final manuscript.
Role of funding source
Nothing declared.
Acknowledgements
We thank the staff of the Mood and Anxiety Disorders Unit of the University of Turin, which helped us to collect all patients’ data.
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