Skip to main content
×
×
Home

Family psychoeducation for major depression: randomised controlled trial

  • Kae Shimazu (a1), Shinji Shimodera (a1), Yoshio Mino (a2), Atsushi Nishida (a3), Naoto Kamimura (a4), Ken Sawada (a5), Hirokazu Fujita (a4), Toshi A. Furukawa (a6) and Shimpei Inoue (a7)...
Abstract
Background

The value of family psychoeducation for schizophrenia has been well established, and indications for its use have recently expanded to include bipolar affective disorder. However, no study to date has adequately examined its use in depression.

Aims

To examine family psychoeducation in the maintenance treatment of depression and to investigate the influence of the family's expressed emotion (EE) on its effectiveness.

Method

Of 103 patients diagnosed with major depression and their primary family members, 57 pairs provided written informed consent. The pairs were randomly allocated to the intervention (n = 25) or control (n = 32). One family in the intervention group and two in the control group withdrew their consent after randomisation. The intervention group underwent four psychoeducation sessions consisting of didactic lectures about depression and group problem-solving focusing on how to cope in high-EE situations. Patients did not attend these sessions. Patients in both the intervention and control groups received treatment as usual. The families' EE levels were evaluated through Five-Minute Speech Samples. The primary outcome was relapse.

Results

Time to relapse was statistically significantly longer in the psychoeducation group than in the control group (Kaplan–Meier survival analysis, P = 0.002). The relapse rates up to the 9-month follow-up were 8% and 50% respectively (risk ratio 0.17, 95% CI 0.04–0.66; number needed to treat 2.4, 95% CI 1.6–4.9). In Cox proportional hazard analysis, baseline EE did not moderate the effectiveness of the intervention.

Conclusions

Family psychoeducation is effective in the prevention of relapse in adult patients with major depression.

    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      Family psychoeducation for major depression: randomised controlled trial
      Available formats
      ×
      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      Family psychoeducation for major depression: randomised controlled trial
      Available formats
      ×
      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      Family psychoeducation for major depression: randomised controlled trial
      Available formats
      ×
Copyright
Corresponding author
Shinji Shimodera, Kohasu, Okoh-cho, Nankokushi, Kochi 783-8505, Japan. Email: shimodes@kochi-u.ac.jp
Footnotes
Hide All

See editorial, pp. 338–340, this issue.

This study was supported by a Grant-in-Aid for Scientific Research, Ministry of Health, Labour and Welfare, 2004 (Comprehensive Research Project on Science of Longevity).

Declaration of interest

None.

Footnotes
References
Hide All
1 Leff, J, Vaughn, C. Expressed Emotion in Families. Guilford, 1985.
2 Bebbington, P, Kuipers, L. The predictive utility of expressed emotion in schizophrenia: an aggregate analysis. Psychol Med 1994; 24: 707–18.
3 Falloon, IR, Boyd, JL, McGill, CW, Razani, J, Moss, HB, Gilderman, AM. Family management in the prevention of exacerbation of schizophrenia: a controlled study. New Engl J Med 1982; 306: 1437–40.
4 Leff, J, Kuipers, L, Berkowitz, R, Eberlein-Vries, R, Sturgeon, D. A controlled trial of social intervention in the families of schizophrenic patients. Br J Psychiatry 1982; 141: 121–34.
5 Shimodera, S, Inoue, S, Mino, Y, Tanaka, S, Kii, M, Motoki, Y. Expressed emotion and psychoeducational intervention for relatives of patients with schizophrenia: a randomized controlled study in Japan. Psychiatry Res 2000; 96: 141–8.
6 Miklowitz, D, Goldstein, MJ, Nuechterlein, KH, Snyder, KS, Mintz, J. Family factors and the course of bipolar affective disorder. Arch Gen Psychiatry 1988; 45: 225–31.
7 Kim, EY, Miklowitz, DJ. Expressed emotion as predictor of outcome among bipolar patients undergoing family therapy. J Affect Disord 2004; 82: 343–52.
8 Reinares, M, Colom, F, Sanchez-Moreno, J, Torrent, C, Martinez-Aran, A, Comes, M, et al. Impact of caregiver group psychoeducation on the course and outcome of bipolar patients in remission: a randomized controlled trial. Bipolar Disord 2008; 10: 511–9.
9 Miklowitz, DJ, George, EL, Richards, JA, Simoneau, TL, Suddath, RL. A randomized study of family-focused psychoeducation and pharmacotherapy in the outpatient management of bipolar disorder. Arch Gen Psychiatry 2003; 60: 904–12.
10 Rea, MM, Tompson, MC, Miklowitz, DJ, Goldstein, MJ, Hwang, S, Mintz, J. Family-focused treatment versus individual treatment for bipolar disorder: results of a randomized clinical trial. J Consult Clin Psychol 2003; 71: 482–92.
11 Vaughn, CE, Leff, JP. The influence of family and social factors on the course of psychiatric illness. A comparison of schizophrenic and depressed neurotic patients. Br J Psychiatry 1976; 129: 125–37.
12 Hooley, JM, Orley, J, Teasdale, JD. Levels of expressed emotion and relapse in depressive patients. Br J Psychiatry 1986; 148: 642–7.
13 Priebe, S, Wildgrube, C, Müller-Oerlinghausen, B. Lithium prophylaxis and expressed emotion. Br J Psychiatry 1989; 154: 396–9.
14 Okasha, A, El Akabawi, AS, Snyder, KS, Wilson, AK, Youssef, I, el Dawla, AS. Expressed emotion, perceived criticism, and relapse in depression: a replication in an Egyptian community. Am J Psychiatry 1994; 151: 1001–5.
15 Hayhurst, H, Cooper, Z, Paykel, ES, Vearnals, S, Ramana, R. Expressed emotion and depression. A longitudinal study. Br J Psychiatry 1997; 171: 439–43.
16 Mino, Y, Shimodera, S, Inoue, S, Fujita, H, Tanaka, S, Kanazawa, S. Expressed emotion of families and the course of mood disorders: a cohort study in Japan. J Affect Disord 2001; 63: 43–9.
17 Kessler, RC, Demler, O, Frank, RG, Olfson, M, Pincus, HA, Walters, EE, et al. Prevalence and treatment of mental disorders, 1990 to 2003. New Engl J Med 2005; 16: 2515–23.
18 Kanai, T, Takeuchi, H, Furukawa, TA, Yoshimura, R, Imaizumi, T, Kitamura, T, et al. Time to recurrence after recovery from major depressive episodes and its predictors. Psychol Med 2003; 33: 839–45.
19 Ramana, R, Paykel, ES, Cooper, Z, Hayhurst, H, Saxty, M, Surtees, PG. Remission and relapse in major depression: a two-year prospective follow-up study. Psychol Med 1995; 25: 1161–70.
20 Greenberg, PE, Kessler, RC, Birnbaum, HG, Leong, SA, Lowe, SW, Berglund, PA, et al. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry 2003; 64: 1465–75.
21 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (4th edn) (DSM–IV). APA, 1994.
22 Folstein, MF, Folstein, SE, McHugh, PR. ‘Mini-mental state’: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975; 12: 189–98.
23 Magaña, AB, Goldstein, JM, Karno, M, Miklowitz, DJ, Jenkins, J, Falloon, IR. A brief method for assessing expressed emotion in relatives of psychiatric patients. Psychiatry Res 1986; 17: 203–12.
24 Shimodera, S, Mino, Y, Inoue, S, Izumoto, Y, Kishi, Y, Tanaka, S. Validity of a Five-Minute Speech Sample in measuring expressed emotion in the families of patients with schizophrenia in Japan. Compr Psychiatry 1999; 40: 372–6.
25 Kavanagh, DJ, O'Halloran, P, Manicavasagar, V, Clark, D, Piatkowska, O, Tennant, C, et al. The Family Attitude Scale: reliability and validity of a new scale for measuring the emotional climate of families. Psychiatry Res 1997; 70: 185–95.
26 Fujita, H, Shimodera, S, Izumoto, Y, Tanaka, S, Kii, M, Mino, Y, et al. Family attitude scale: measurement of criticism in the relatives of patients with schizophrenia in Japan. Psychiatry Res 2002; 31: 273–80.
27 Shimodera, S, Mino, Y, Fujita, H, Izumoto, Y, Kamimura, N, Inoue, S. Validity of a five-minute speech sample for the measurement of expressed emotion in the families of Japanese patients with mood disorders. Psychiatry Res 2002; 112: 231–7.
28 Uehara, T, Yokoyama, T, Goto, M, Ihda, S. Expressed emotion and short-term treatment outcome of outpatients with major depression. Compr Psychiatry 1996; 37: 299304.
29 Hamilton, M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967; 6: 278–96.
30 Beck, AT, Ward, CH, Mendelson, M, Mock, J, Erbaugh, J. An inventory for measuring depression. Arch Gen Psychiatry 1961; 4: 561–71.
31 Leff, J, Vearnals, S, Wolff, G, Alexander, B, Chisholm, D, Everitt, B, et al. The London Depression Intervention Trial. Randomised controlled trial of antidepressants v. couple therapy in the treatment and maintenance of people with depression living with a partner: clinical outcome and costs. Br J Psychiatry 2000; 177: 95100.
32 Sackeim, HA. Continuation therapy following ECT: directions for future research. Psychopharmacol Bull 1994; 30: 501–21.
33 National Institute for Health and Clinical Excellence. Depression: The Treatment and Management of Depression in Adults (partial update of NICE Clinical Guideline 23). NICE, 2009.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

The British Journal of Psychiatry
  • ISSN: 0007-1250
  • EISSN: 1472-1465
  • URL: /core/journals/the-british-journal-of-psychiatry
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 0
Total number of PDF views: 54 *
Loading metrics...

Abstract views

Total abstract views: 215 *
Loading metrics...

* Views captured on Cambridge Core between 2nd January 2018 - 27th May 2018. This data will be updated every 24 hours.

Family psychoeducation for major depression: randomised controlled trial

  • Kae Shimazu (a1), Shinji Shimodera (a1), Yoshio Mino (a2), Atsushi Nishida (a3), Naoto Kamimura (a4), Ken Sawada (a5), Hirokazu Fujita (a4), Toshi A. Furukawa (a6) and Shimpei Inoue (a7)...
Submit a response

eLetters

Re: Clinical Trials of Drug and Behavior Therapies: pharmacological issue

Klaus Martin Beckmann, Psychiatrist
05 December 2012

Dear Sir

We are writing from Australia where we participate in an evidence based journal club. Shimazu et al paper on family psychoeducation for major depression: randomised controlled trial did strike us a very suitable paper for discussion at the journal club. In preparation for thejournal club we appraised and reviewed article with responses. We found some possibly minor issues with the statistics like power of the study andlack of p values, lack of intention to treat that we do not wish to go into detail here.

We write today to add to comments and responses added so far with respect to a potentially very important issue: we are concerned at the unspecific and broad way antidepressant medication is referred to in the paper. This pharmacotherapy issue has not been raised in the article and responses published so far, so we are happy to share our views with the authors and readers of the BJP, despite the paper having been published mid 2011: We believe it is important to highlight Table 1 page 387 where talk is about antidepressant dosage in mg, mean (s.d.) in the interventiongroup 100.3 (71.5) and the control group 88.1 (60.9). Giving the vast differences in therapeutic and safety windows within classes of antidepressants and medications within the classes, we wonder in how far these numbers are adding to the evidence: there is no reference to what type of medication these milligrams refer to, neither is there reference to the specific antidepressant used or to a class of antidepressant. We suggest it is important to be explicit about those details so to understand the pharmacology that is relevant to this paper. We are curiousas to which class was used, whether it were SSRI, TCA, MAOI or maybe another class of drug; whether is was Fluoxetine that was used or maybe Fluvoxamine, whether Nortryptyline or maybe Amitriptyline was used, or maybe even Moclobemide or Phenelzine, whether Venlafaxine or Reboxetine or Agomelatine? We fear that in the absence of details re the specific medication quoting milligrams only in general, at best does not add much. However this is not withstanding that we are impressed with this pioneering paper in the field of family psychoeducation in relatives of patients with depression.

... More

Conflict of interest: None declared

Write a reply

Re:Clinical Trials of Drug and Behavior Therapies: Methodological Issues

Shinji Shimodera, Doctor
02 November 2011

Shinji Shimodera , Toshi A. Furukawa, Atsushi Nishida, Kae Shimazu, Hirokazu Fujita, Shimpei Inoue

Sir, we would like to thank Patra and Subodh very much for their interest in and their very thorough reading of our study1. Most of their questions are factual ones and we are very grateful that we were given an opportunity to clarify them.First, whether to call further treatment of patients in partial or full remission after the fully syndromatic episode, as in our study, continuation/maintenance treatment is a terminological issue and not a medically substantive one. And we think our usage of the terms is in consonance with the majority of psychiatrists of the world, as for exampledone by Paykel et al in their famous study of cognitive therapy to preventrelapse after acute episode of major depression2.Second, of the 57 patients who entered the trial, 27 suffered from a single episode and 30 from recurrent major depression. Those with their first lifetime major depressive episode received continuation treatment after their acute phase treatment. The comorbidities of our sample included 3 with substance use disorder, 10 with anxiety disorders, 1 with personality disorder. It is true that we did not methodically check the intellectual or health status of the primary family members but none apparently suffered from serious dysfunction in these regards.We regret the fact that we did not mention the ethics review committee's approval in the published paper. It had been reviewed and approved by the ethic review committee of Kochi Medical School in 2003, prior to the commencement of the study.On the other hand, it is not true that four caregivers had their psychoeducation sessions individually. It is only four sessions out of 16 for these four family members that were conducted individually either in the hospital or at home. Altogether 4 out of 216 sessions (1.9%) were individually delivered. We reasoned that in this first-ever efficacy trialof family psychoeducation for major depression, it would be better for us to deliver the best therapy possible.Our definition of remission reflected some arguments that the accepted threshold might be too high to define true remission 3, 4. Changing the threshold for remission to 7/8, instead of 6/7, made little change to the findings.Lastly, we would like to thank these authors again for their meticulous reading of our article. The truth is that there were 6 (25%) families withhigh EE in the intervention group and 10 (33%) in the control group.

References:1.Shimazu K, Shimodera S, Mino Y, Nishida A, Kamimura N, Sawada K, et al.Family psychoeducation for major depression: randomised controlled trial. Br J Psychiatry 2011 May;198:385-90.2.Paykel ES, Scott J, Teasdale JD, Johnson AL, Garland A, Moore R, et al.Prevention of relapse in residual depression by cognitive therapy: a controlled trial. Arch Gen Psychiatry 1999 Sep;56(9):829-35.3.Zimmerman M, Posternak MA, Chelminski I. Is the cutoff to define remission on the Hamilton Rating Scale for Depression too high? J Nerv Ment Dis 2005 Mar;193(3):170-5.4.Furukawa TA, Akechi T, Azuma H, Okuyama T, Higuchi T. Evidence-based guidelines for interpretation of the Hamilton Rating Scale for Depression.J Clin Psychopharmacol 2007 Oct;27(5):531-4.

Conflict of Interest:None declared

Conflict of Interest:None declared
... More

Conflict of interest: None Declared

Write a reply

Family psychoeducation for major depression: randomised controlled trial

Bichitra N. Patra, Senior Resident Doctor
14 September 2011

Sir,We read with interest the paper by Shimazu et al1. It adds robustness to already existing evidence for the role of family psychoeducation in psychiatric disorders. The study is having sound methodology (i.e. randomised controlled trial) with adequate blinding. The study has its strength of being the first ever study to examine the effect of family psychoeducation for major depressive disorder. The authors described the possible limitation of the study honestly. A source of funding (Grant-in-Aid for Scientific Research, Ministry of Health, Labour and Welfare, 2004)is also mentioned. However, there are some issues which should be further looked in to. The aim was to examine family psychoeducation in the maintenance treatment of depression. But the patients included were of continuation/maintenance phase. Again the patients who are in partial remission cannot be considered as in continuation/maintenance phase.2 Alsoit was not mentioned how many patients were of single or recurrent episodes as single episode patients need not receive maintenance phase treatment. Any other psychiatric co-morbidity in the patients included (substance abuse or personality disorders) were not mentioned as it has treatment implications. The health status and intellectual functioning of the primary family member included in the study was not mentioned, which would compromise their active participation in psycho educational sessions. The authors are silent on the ethical clearance of the study. For four caregivers psychoeducation sessions were done in home individually not in group sessions which were also included in the final analysis, which was not part of the methodology mentioned could also have an effect on the efficacy of the study. Remission was defined by the authors as Hamilton rating scale for depression score ? 6, but the normal score is mentioned as ? 7.3 The authors have not mentioned the reason for keeping a low score of HRSD in the study. Lastly, it could be a printing mistake in last line of table-1, where it is mentioned that high EE (as per FMSS) was seen in 7 patients in intervention group and none in controlgroup but as per the results mentioned in the article it is seen in 6 patients in intervention group and 10 in control group.

References1.Shimazu K, Shimodera S, Mino Y, Nishida A, Kamimura N, Sawada, Fujita H,Furukawa TA, Inoue S. Family psychoeducation for major depression: randomised controlled trial. Br J Psychiatry 2011; 198:385-390.2.American Psychiatric Association. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. Am J Psychiatry 2010; 167 (Octsuppl).3.Blacker D. Psychiatric Rating Scales. In: Sadock BJ, Sadock VA, Ruiz P, eds. Kaplan and Sadock's Comprehensive Text book of Psychiatry. 9th ed. Vol.1. Philadelphia: Lippincot Williams and Wilkins; 2009: 1047.

Bichitra N. Patra, Subodh B.N., Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh - 160012, Indiapatrab.aiims@gmail.com

... More

Conflict of interest: None declared

Write a reply

Clinical Trials of Drug and Behavior Therapies: Methodological Issues

Dr. Partha Sarathi Biswas, Senior Resident (Psychiatry)
01 June 2011

Shimazu et al1 designed one randomized controlled trial highlighting efficacy of family psychoeducation in the maintenance treatment of major depression. By definition the index trial was a pragmatic trial. A treatment as clinically practiced (‘treatment as usual’) is compared here to one of the clinically relevant alternatives, family psychoeducation. They have not used behavioral “placebo� control groups, which are also not ideally needed in such pragmatic trial. However, this study has faced bias in recruitment and selection procedureslike exclusion of previous non-responders. Sample homogeneity is one of the ways to enhance the power of the study. The authors excluded patients who received ECT which improved the homogeneity. The bipolarity status, number of previous episodes, duration of untreated psychosis (DUP) and associated specifier (like melancholic, atypical and psychotic features, etc) might have been taken as inclusion criteria to improve it further. Alternatively, as clinical relevance is the primary consideration in pragmatic trials, differences in treatment structure (e.g. number of antidepressants, doses and length of treatment and follow-up sessions) maybe ignored if they reflect clinical practice.

Participants might have a preference for only antidepressant or combined therapy, and this preference might undermine adherence (which is not addressed in this study), influence dropout rate, and even affect treatment response2. This could be avoided with a design of two levels ofrandomization, i.e first randomization to two different treatments protocols and second where they receive their preferred treatment. The participants’ expectation which might be a confounding was not a concernin this pragmatic trial.

One very frequently emerged question “Does combining family psychoeducation therapy with antidepressant treatment enhance the maintenance of treatment effects following drug withdrawal?� can only beaddressed following drug withdrawal3.

Allegiance effects could have been minimized if drug and family psychoeducation were each administered by professionals who had a primary allegiance to the type of therapy they were administering and expertise inits administration. This issue is not addressed clearly by Shimazu et al1.

In this pragmatic trial, the goal was to duplicate clinical practice,including practitioners’ clinical judgments in tailoring treatments to patients. However, therapy protocols need to be clearly specified (especially antidepressant or antipsychotic) and fidelity to treatment protocols maintained if a clearly defined therapy is to be evaluated, and the therapy is to be duplicated by others. Information obtained from this drug-behavior therapy trial might be maximized if measures of the putativetherapeutic mechanisms of behavioral treatment (e.g., self-efficacy, symptoms-related coping) were obtained.

Adherence data can provide useful information about treatment acceptability in pragmatic trials. Adherence appears to be more easily assessed with drug therapy. Measures of adherence with behavior therapy are often limited to self-report, though completion of in-therapy tasks and/or homework assignments and tape recorders capable of electronic monitoring use of relaxation tapes have been used as “objective� measures of adherence4. Had the authors been taken some of these measures the confounding due to adherence would have been reduced.

The authors could have entered some additional factors in Cox proportional hazard analysis like compliance, DUP, type of antidepressant,predominant side effect and psychotic status of current episode, etc. Thusthe analysis might have been better powered.

We discussed the methodological issues, here are not considered immutable, but are expected to evolve as investigators creatively tackle design issues when conducting drug-behavioral trials.

References

1. Shimazu K, Shimodera S, Mino Y, Nishida A, Kamimura N, Sawada K etal. Family psychoeducation for major depression: randomized controlled trial. The British J Psychiatry 2011; 198: 385–390.

2. Elkin I, Pilkonis PA, Docherty JP, Sotsky SM. Conceptual and methodological issues in comparative studies of psychotherapy and pharmacotherapy, I: active ingredients and mechanisms of change. Am J Psychiatry 1988; 145:909-917.

3. Holroyd K. Integrating pharmacologic and nonpharmacologic treatments. In Headache Diagnosis and Interdisciplinary Treatment (ed CD Tolison, RS Kunkel): 309-320. Baltimore: Williams &Wilkins, 1993.

4. Epstein LH. The direct effects of compliance of health outcomes. Health Psychol 1984;3:385-393.

Authors:

Dr. Partha Sarathi Biswas*1, Ms. Devosri Sen2, Dr. (Prof.) V.K. Sinha3

Address:

1.Senior Resident, Department of Psychiatry, Ranchi Institute of Neuro- Psychiatry and Allied Sciences (RINPAS), Kanke, Ranchi, India;

2.PhD Scholar, Department of Clinical Psychology, Central Institute of Psychiatry (CIP), Kanke, Ranchi, India;

3.Prefessor of Psychiatry, Central Institute of Psychiatry (CIP), Ranchi, India.

* Corresponding author
... More

Conflict of interest: None Declared

Write a reply

×

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *