THE EFFICACY OF PSYCHOEDUCATION ON THE QUALITY OF LIFE OF PATIENTS ON ROUTINE TREATMENT WITH IMIPRAMINE FOR MAJOR DEPRESSIVE DISORDER

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THE EFFICACY OF PSYCHOEDUCATION ON THE QUALITY OF LIFE OF PATIENTS ON ROUTINE TREATMENT WITH IMIPRAMINE FOR MAJOR DEPRESSIVE DISORDER

SUMMARY

Objectives: To determine the efficacy of a combination of psychoeducation and low dosage tricyclic antidepressant, imipramine on the quality of life of patients with major depression and compare it with imipramine alone.

Study Design/Setting: A randomized controlled trial involving 87 adults aged 18-65 years with major depression presenting at the GOPD of JUTH, Jos.

Methods:  Subjects were matched according to their range of BDI-II scores as mild, moderate and severe major depression and randomly allocated to control and intervention arms. The interventions offered were a combination of psychoeducation and imipramine in the intervention arm and imipramine alone in the control arm. Data collected from subjects include sociodemographic data along with the DSM-IV diagnostic criteria, BDI-II scores and the WHOQOL-

BREF scores.  Subjects were followed-up every 4 weeks and relevant BDI-II and WHOQOLBREF scores collected at each visit. Adherence to treatment was also assessed via pill count at each visit.

Results:   At the end of the twelve weeks of study, there was a statistically significant difference between the two study arms in all the domains of quality of life assessed at a 0.05% p value.

There was also a consistent trend towards higher improvement in mean quality of life in the intervention arm (psychoeducation plus imipramine) compared with the control arm (imipramine only) in all the quality of life domains assessed (i.e., physical, psychological,

 

social and environmental). All the subjects also reported an overall poor perception of quality of life at baseline (p<0.05).

Of the eighty seven subjects who completed the study, 34 (39.1%) had the BDI-II scores for severe depression, while 38 (43.8%) had BDI-II scores in the range for moderate depression and 10 (11.5%) had a BDI-II scores in the range for mild depression. The mean baseline BDI-II scores for the control and the intervention were 32.0±10.3 and 30.0±10.5 respectively, with no significant difference (t=-0.904, p=0.369) between the two arms.

Sixty eight (78.2%) subjects had BDI-II scores reduction of 50% and above at the end of the study. Of these, 25 (59.5%) were in the control arm and 95.6% in the intervention arm.

CONCLUSION: At the end of twelve weeks of study, there was a statistical significant difference between the two study arms in all the domains of quality of life assessed. Though both groups showed some improvement in quality of life, those in the intervention group were better. There was also significant inverse correlation between the BDI-II scores and scores on all WHOQOLBREF domains (I.e. the severity of depressive symptoms scores were inversely related to the quality of life scores.) The intervention arm had a better reduction in depressive symptoms.

TABLE OF CONTENTS

CONTENTS                                                                                                                        PAGE

Certification……………………………………………………………………………………………………………

….  i

Declaration……………………………………………………………………………………………………………..

….  ii

Dedication….…………………………………………………………………………………

….  iii

Acknowledgement…………………………………………………………………………

……

 

iv

Table of

contents……………………………………………………………………………………..

 

v

List of

figures…………………………………………………………………………………………..

 

vi

List of

abbreviations……………………………………………………………………………

 

vii

Summary……………………………………………………………………………………

 

viii

CHAPTER 1

1.0 Introduction……………………………………………………………………………………….1

1.1 Background…………………………………………………………………………………..1

1.2 Statement of the Problem……………………………………………………………………5

1.3 Justification of the Study……………………………………………………………………6

1.4 Study Hypothesis……………………………………………………………………………7

1.5Aims and Objectives………………………………………….…….…………………………….7

1.6 Relevance of the Study to Family Medicine…………………………………………………8 CHAPTER 2

2.0                                                                                                                                         Literature

Review……………………………………………………………………………….10

2.1.1                                                                Definition                                                                of

depression……………………………………………………………………………10

2.1.2

Classification………………………………………………………………………………….10

2.2                                           Brief                                           history                                           of

depression………………………………………………………………………11

2.3                                                               Epidemiology                                                              of

depression…………………………..…………………………………………14

2.3.1

Prevalence…………………………………………………..…………………………………14

2.3.2                                                              Comorbidity                                                              of

depression………………………………….…………………………………16

2.3.3                                                                Disability                                                               and

depression………………………………………………………………………..17

2.4 Etiology of depression………………………………………………………………………….

19

2.5.1

Presentation……………………………………………………………….……………………..30

2.5.2

Diagnosis………………………………………………………………………………………31

2.5.3                               Quality                               of                                life                               in

depression…………………………………………………………………….35

2.5.4                   Screening                   for                   depression                   in                   Primary

Care…………………………………………………….36

2.5.5              The              Management              of              depression              in              Primary

Care……………………………………………….36

2.5.6                                                                Treatment                                                                of

depression………………………………………………………………………36

2.5.7

Psychoeducation………………………………………………………………………………37

CHAPTER 3

3.0                                                                 Materials                                                                 and

Method……………………………………………………………………………56

3.1                                                               Study                                                               Procedure

…………………………………………………………………………………62

3.11                                                                                                                                              Data

Analysis…………………………………………………………………………………..66

3.12                                                                                                                                          Ethical

Consideration…………………………………………………………………………..67

CHAPTER 4

4.1                            Subject                            flow                             through                            the

study…………………………………………………………………68

4.2                           Baseline                           characteristics                          of                           the

Subjects…………………………………………………………70

4.3 Baseline Beck’s Depression Inventory (BDI-II

Scores……………………………………………….72

4.4            Post-Exposure             Characteristics            of         Subjects           in         the      Two     Arms   of Study…………………………73

4.5                                           Quality                                           of                                           Life

Assessment……………………………………………………………………………74

4.6                                                                                                                                     Correlation

Analysis…………………………………………………………………………….82

4.7                                                                                                                                      Regression

Analysis……………………………………………………………………………………83

4.8                                                                 Adherence                                                                  to

medication………………………………………………………………………………84

4.9                             Side                            effects                             of                             treatment

profile…………………………………………………………………86

CHAPTER 5

Discussion

5.1                          Demographic                         correlates                         in                          major

depression……………………………………………………89

5.2                                                                   Efficacy                                                                   of

Psychoeducation……………………………………………………………………92

5.3                              Predictors                             of                              quality                             of

life…………………………………………………………………………….95

5.4                                        Relevance                                        to                                        Family

Medicine………………………………………………………………….97

5.5

Conclusion………………………………………………………………………………………98

5.6                     Strength                     and                      limitations                     of                      the

study…………………………………………………………………..99

5.7                                                                                                                                             Future

research…………………………………………………………………………………100

5.8

Recommendations…………………………………………………………………………………….101 REFERENCES…………………………………………………………………………………….

102

CHAPTER 1

1.0 INTRODUCTION

1.1        Background 

Major depressive disorder is an episode of illness lasting at least two weeks, characterized by, markedly diminished interest or pleasure, change in appetite and weight, change in quantity of sleep, fatigue and morbid thoughts.1 Depression causes depressed mood, cognitive, psychomotor, and other dysfunctions such as poor concentration, fatigue, loss of sexual desire and menstrual

abnormalities.1-3

Depression is regarded as a major public health concern.1 Depression is also a common disorder

seen in the outpatient setting/Family Practice clinics.4, 5 According to the World Health

Organization, depression is the most common psychiatric disorder and ranked as the fourth major cause of disease burden worldwide. 6, 7 It is projected to be second only to cardiovascular disease

by the year 2020.7,  8 Today, depression is already the second cause of disability associated live years (DALYS) in the age category, 15-44 years for both sexes combined.9 In most countries the number of People who suffer from depression during their lives fall within 8-12% range.10 Studies in Africa have found rates ranging from 0.8% for 12 months prevalence in Nigeria to a point prevalence of 1.55% and 20% for community sample in Rwanda and Uganda respectively.11 Amoran  and colleagues in 2007 found an overall prevalence of depression of

5.2% among adults in Oyo state, Nigeria.12

The etiology of depression, as in other functional mental disorders is unclear and multifaceted. However, genetic predisposition, certain hormonal abnormalities, altered neurotransmission,

psychosocial and environmental stressors have been implicated.13, 14 Deficiencies of vitamins B1, B6, B12, reduced levels of folic acid and lack of omega-3 fatty acids have likewise been implicated.15

Diagnosis is made when symptoms cause significant distress or impairment and they are not better accounted for by a medical condition or by bereavement.1 According to the DSM-IV classification, a diagnosis of Major Depressive Disorder is possible only when there is evidence of significant interference with functioning. An important correlate of functioning is quality of life.16 The World

Health Organization has described the quality of life as “individual’s perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” This is similar to one of the communication techniques used  in Family Medicine during patient-doctor encounter  in which the doctor listens to the story, look for cues and explore the fears, ideas, function/concerns and expectations  (FIFE) of the patient in that encounter. It incorporates the person’s physical health, psychological state, level of independence, social relationships, personal beliefs and his relationships to salient features of the environment in assessing the overall wellbeing of the person.17 People with depression have impaired quality of life and functioning in home, work, and social roles.18

The WHOQOL-BREF (World Health Organization quality of life), is a 26-item version of the 100 item instrument of the World Health Organization quality of life (WHOQOL-100) that was developed to provide a short form quality of life assessment concerned with the measuring of different aspect of life to the respondents, and how satisfactory or problematic are their experiences with these factors. It is a self –report questionnaire containing four domains, namely: physical health (7 items), psychological status (6 items), social relationship (3 items), and environmental conditions (8 items).19

The Beck’s Depression Inventory (BDI) is a series of questions developed by Aaron T. Beck in 1961 to measure the intensity, severity, and depth of depression in patients with psychiatric diagnosis.20 A second version of the long form (BDI-II) was later developed to reflect the revision in the Fourth Edition of Statistical Manual of Mental Disorders (DSM-IV-TR).21 It has 21 items designed to assess the cognitive, behavioral, affective and somatic symptoms of depression. It requires about ten minutes to complete and has a two week time frame, including the day of interview.21 BDI-II categorizes depressed subjects into mild (score of 14-19), moderate (20-28) and severe depression (score of 29-63).21

The World Health Organization (WHO) in response to the threatening burden of depression has, in line with its key policy recommendation adopted that common mental health problems like depression should be managed in primary care.22

Pharmacotherapy is the main stay of treatment of clinical or major depression in primary care. Among the different classes of drugs used for this, the Tricyclic antidepressants (TCAs) are the

most commonly used in many developing countries because of low cost.23, 24 The efficacy of the TCAs is similar to those of Serotonin Specific Reuptake Inhibitors (SSRIs) used as first line drugs

in the developed world.23, 24 The side effects of the TCAs get worse as doses are increased.23

Potentially adequate antidepressant treatment has been defined as treatments based on the smallest doses recommended by the U.S. Agency for Health Care Policy and Research Guidelines for the Treatment of Depression in Primary Care (for example, 75mg of imipramine or 20mg of fluoxetine).25 Hence, maintaining the course of treatment of depression with the above doses recommended by the U.S. Agency for Health Care Policy and Research, is likely to reduce adverse effects and improve adherence to treatment.23-25 Imipramine (Tofranil), one of the tricyclic classes of antidepressants, used in this study elevates mood by raising the level of the transmitters in the brain. It was first synthesized in the late 1940’s and was approved by the United States of America food and drug administration for depression in 1959 and for enuresis in 1973.26

The current goal for treatment of major depressive disorder is to achieve remission. However, patients who achieve full asymptomatic remission from depressive symptoms can still experience functional impairment; thus, restoring psychosocial functioning is increasingly being

identified as an important goal of depression therapy.27,  28  Improvement in depressive symptoms

during treatment is related to improvement in quality of life.29,  30 Indeed, many researchers now regard assessment of both mood symptoms and functional outcomes essential to measuring treatment-related improvement and remission from Major depressive disorder.28-31 However, despite scientific advances in the treatment of depression, antidepressant as first line agents yield only modest remission rates.32 Recent studies indicate that only one out of three subjects who received a standard first line antidepressant attained remission.32 This has been attributed to the presence of residual symptoms.32 Experts believe this can be prevented by the inclusion of psychosocial, especially psychoeducation and cognitive behavioral therapy.33 Combining

antidepressants with psychoeducation have been shown to improve quality of life.33, 34

Researchers continue to seek complementary treatments that may improve residual symptoms of depression, sustain remission and thus improve quality of life. This study tries to add to this pool of knowledge.

 

 

 

 

1.2       Problem Statement:

Depression contributes significantly to the global burden of disease in developing countries.35 Poor case detection and inadequate numbers of mental health staff have been associated with increased morbidity among individuals with depression presenting to primary care.35 In Nigeria, as in most developing countries, general practitioners (GPs) may fill this treatment gap.35

Depression is a common mental disorder affecting about 121 million people worldwide1 and are associated with huge losses in quality of life for patients and their relatives.36

The lifetime prevalence rate of a major depressive episode among adults aged 18 years and over in Nigeria has been reported to be 3.1%.37 Consequently, with the current population estimates for the country, about five million Nigerians would have experienced a major depressive episode in their lifetime.37 Depressive disorders are a significant public health issue, leading to disability, and cause a high economic burden for society.38 Depression also imposes an intense burden on an individual, community and health services throughout the world. Latest estimates from a Global Burden of Disease Study 2000 indicate that unipolar depressive disorder account for 4.4% of the global disease burden (65 million[Disability Associated Live Years] lost in total) in the same range as the total burden attributed to ischemic heart disease, diarrheal disease or the combined impact of asthma and chronic obstructive airway disease.6

Though great strides in the management of major depression have been made since the last few decades, many subjects still fail to respond to treatments, relapse under maintenance therapy, and

spend a large amount of their lifetime in a fully or partially symptomatic status.39, 40 

Therefore, there is a clear need for alternative approaches other than pharmacologic ones to treat major depression and address many factors that affect the quality of life of patients with major depression. Research has repeatedly demonstrated for a large number of mental illnesses that

psychoeducation; a form of psychotherapy with medication produces the best outcomes.41. Numerous randomized control trials in wealthy countries document the efficacy of psychosocial based interventions in reducing symptoms and thus improving quality of life.42 However, psychotherapy trials in less affluent countries like Nigeria are sparse43 with little attention been given to single, brief but cost effective psychosocial intervention like psychoeducation.44

In Nigeria, there is no standardized policy for the systematic use of psychosocial interventions for the management of mentally disordered patient compared to United State of America and some countries in Europe.44 Major depressive disorder (MDD) is associated with significant disability, having a profound impact on psychosocial functioning. Therefore, studying the impact of treatment on psychosocial functioning in MDD could help further improve the standard of care.

1.3     Justification of the study:

The focus of treatment of major depression has shifted from that based purely on medication alone to one that takes into consideration treatment that also improves quality of life.45 Hence, the need for research on interventions that focus on improvement of the quality of life of these patients. The study goes beyond just treating the disease of the patient by considering the psychosocial factors in health of patients with major depression. It will also test an intervention that is expected to improve their quality of life and consequently rendering a holistic care to these patients. This is the hallmark of Family Medicine. Psychoeducation, if integrated into clinical practice, is simple

and more cost effective than routine medical treatment alone.46-48

 

 

1.4 Study Hypothesis

Psychoeducation combined with routine drug treatment leads to a greater reduction in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II), and a greater increase of subjective perception of the quality of life as measured by the World Health Organization Quality of life scale in patients diagnosed with major depression, when compared to pharmacotherapy

alone.

1.5 Aim and objectives                                  

1.5.1 Aim of study: 

To assess the efficacy of psychoeducation in improving the quality of life of depressed patients who are on routine drug treatment with a view to recommending a structured psychoeducation to be included in the management of such patients.

1.5.2  Objectives:

The general objective is to determine the efficacy of a combination of psychoeducation and low dosage tricyclic antidepressant, imipramine on the quality of life of patients with major depression and comparing it with the effectiveness of low dosage imipramine alone.

Specific objectives are:

  1. To determine and compare the mean quality of life scores as measured by the abbreviated version of the World Health Organization quality of life scores (WHOQOL-BREF) between subjects who received both psychoeducation and pharmacotherapy(Imipramine) with that of subjects who received only drug treatment at the end of eight weeks and twelve weeks follow up visits.
  2. To determine and compare the mean depression scores using the Becks Depression InventoryII (BDI-II) between subjects who received both psychoeducation and pharmacotherapy with the scores of those on Pharmacotherapy alone at the end of eight weeks and twelve weeks of follow up visits.
  3. To determine and compare the proportion of subjects who have greater or equal to 50% reduction (i.e. improvement) in symptom of depression scores using the BDI-II between the two arms of the study at the end of eight weeks and twelve weeks follow up.

 

1.6       Relevance of the Study to Family Medicine:

Primary care settings are the principal context for treating major depressive disorder.48

The proportion of patients with depressive symptoms in family practice clinics is high and is highly correlated with socio-demographic factors and low socio-economic status.5

Individuals suffering from depression are more likely to present to primary care or general practice clinics than to psychiatric services.5

The WONCA guideline for the treatment of depression in primary care recommends that all patients presenting with depression should be provided education geared towards destigmatization and principles of diagnosis and management of depression.49

Psychoeducation reflects a paradigm shift to a more holistic and competence-based approach, stressing health, collaboration, coping, and empowerment. The clinical practice guidelines for management of depression contained in the National Institute for Health and clinical excellence (NICE) in England recommends that psychotherapy and patient education should be considered when treating patients with major depressive disorder.50 This is best offered by the family physician who possesses the skill and knowledge that enables him to provide continuing, comprehensive and preventive health services in a holistic manner to the patient.50

 

THE EFFICACY OF PSYCHOEDUCATION ON THE QUALITY OF LIFE OF PATIENTS ON ROUTINE TREATMENT WITH IMIPRAMINE FOR MAJOR DEPRESSIVE DISORDER

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