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Đánh giá hiệu quả điều trị rối loạn trầm cảm bằng liệu pháp kích hoạt hành vi kết hợp với amitriptyline tại 4 xã phường, tỉnh khánh hòa tt tiếng anh

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Concept of depression Depression is pathologic status of emotion, manifesting by an inhibitedprocess of all the areas of mental activities emotion, thought, activities….According to the

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Major depressive disorder (MDD) occurs from 5 to 10 percents atprimary health care and approximately 50 percents of MDD and dysphoricdisorders weren’t detected on examination Studies pointed out that themajority of depressed patients didn’t receive appropriate treatments Treatment for dpression current is composed of drug therapy, biologicaltherapy, and psychotherapy International researchers, through clinicaltrials, stated that behavioral therapy (BA) is effective in reducing andsuppress depressive symptoms (Kanter, 2010; Ritschel, 2011) Studiesshowed that BA is simple, teachable, learnable, doesn’t require thattherapists need to have complex skills, easier to accept for population thanwith medicines, effective interms of time and cost, designed favourably forfollowing up patients and for therapists, and easy to generalize in thecommunity

In Vietnam, at primary health care level, treatment for depression ismainly medicines while effective BA for depression hasn’t been applied inthe community yet The research “Assessing the effectiveness of treatingmajor depressive disorder by combining behavioral therapy withamitriptyline at 4 communes/wards of Khanh Hoa province” will illustratethe benefits of BA, with two objectives:

1 Describe MDD patients features at 4 communes/wards of Khanh Hoa province in 2011.

2 Assessing the effectiveness of treating major depressive disorder by combining behavioral therapy with amitriptyline at 4 communes/wards of Khanh Hoa province from 2012-2015.

New contributions of the dissertation

- Provide description on MDD in the community at four communes/wards of Khanh Hoa province, through which, provide to policy makersprevention and management stratergies for currently increasing MDD

- Initially assess the effectivenes of BA combined with amitriptyline at

4 communes/wards of Khanh Hoa province

Struture of the dissertation

The dissertation is composed of 144 pages of main contents, 37 tables,

6 figures, 160 references, 10 appendices (patient’s chart sample, patientslist, research tools)

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Chapter 1 OVERVIEW 1.1 Overview on depression

1.1.1 Concept of depression

Depression is pathologic status of emotion, manifesting by an inhibitedprocess of all the areas of mental activities (emotion, thought, activities…).According to the 10th Internation Classification of Diseases, depression

manifests by three characteristic symptoms: depressed mood, loss of interest

and enjoyment, reduced energy leading to increased fatiguability and diminished

activitiy; seven other common symptoms: reduced concentration and attention,

reduced self-esteem and self-confidence, idea of guilt and unworthiness,pessimistic views of the future, ideas or acts of self-harm or suicide, disturbedsleep, diminished appetite The symptoms exist in at least two weeks

1.1.2 Aetiology of depression

Depression is due to multiple causes, but in general there are three

main causes: psychologic, organic, and endogenous.

1.1.3 Mechanism of depression

Neurotransmitters an receptors play important roles in depression.Central neurotransmitters biogenic amines (serotonin (5HT), epinephrine,norepinephrine (NE), dopamine (DA), acetylcholine, histamine), aminoacids (glutamate, gama aminobutiric acid - GABA), and peptides.Depression is associated with the abnormal functions of neurotransmitters, inwhich, the most important are 5HT, NE, DA, and related receptors; andeven the changes in the forms and functions of the brain

1.1.4 Diagnosis and classification of depression according to ICD-10

1.1.4.1 Diagnostic criteria of depression according to ICD-10

- Three characteristic symptoms: depressed mood, loss of interest and

enjoyment, reduced energy leading to increased fatiguability and diminishedactivitiy

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- Seven other common symptoms: reduced concentration and attention,

reduced self-esteem and self-confidence, idea of guilt and unworthiness,pessimistic views of the future, ideas or acts of self-harm or suicide,disturbed sleep, diminished appetite

- Somatic symptoms of depression: loss of interest or pleasure in

activities that are normally enjoyable; lack of emotional reactivity tonormally pleasurable surroundings and events; waking in the morning 2hours or more before the usual time; depression worse in the morning;psychomotor retardation or agitation; marked loss of appetite; weight loss(often defined as 5% or more of body weight in the past month); markedloss of libido

- Psychotic symptoms such as delusion, hallucination maybe present or

not present in depressed episode

- Determination of the severity of depression (mild, moderate, severe)

bases on the numbers of characteristic and common symptoms ofdepression of patients; the impacts on scopes of social and occupationalactivities of patients; the presence of psychotic symptoms; and the duration

According to Martel (2010), BA is brief, structured therapy aimed at

activating patients by special ways in order to increasing rewardexperiences for their lifes; an independent therapy and an importantcomponent of cognitive behavioral therapy in treating depression

According to Dimidjian (2011), BA is a brief, struturedpsychotherapy aimed at (a) increasing the engagement in appropriate

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activities (usually related to pleasure or mastery experience), (b) decreasingengagement in activities that maintain depression or increase depressionrisk, and (c) dealing with problems limiting access to reward, ormaintaining, or increasing the control of aversive feelings BA will focusdirectly on those objectives.

1.2.2 Mechanism of BA

According to Martell, the techniques of BA increase the activation,decrease the avoidance, increase the contact with positive reinforcement fornon-depressive behaviors, and mood increasing behaviors By the time, thisprocess will lead to decreasing depression symptoms

BA activates patients contacting with positive reinforcers,scheduling to participate in pleasurable events BA helps patientsengaging more on pleasure activities, provides a clear assessment onpatients’ purpose and present behavioral function in order to determinethe activated objectives to focus on BA also trains patients socialskills and how to analyse their behavioral function themselves;encourages the assessment of negative reinforcers for avoidancebehaviors of depression sự đánh giá các củng cố tiêu cực cho hành vi nétránh của trầm cảm As a result, BA activates behaviors decreasing,supressing symptoms, dosen’t imoact on the causes as well as mechanism ofdepression

1.2.3 Objectives of BA

Decrease the slowness, lack of activity of depressed patients; decreaseavoidance behaviors, activate activities to improve emotion; decreasenegative activities

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Chapter 2 STUDY SUBJECTS AND METHODS 2.1 Study subjects

2.2 Locations and period of time of the study

Two Phuoc Tan, Phuoc Hoa wards of Nha Trang city, and two DienSon, Dien Phu communes of Dien Khanh distrist of Khanh Hoa province,from October of 2012 to October of 2015

2 1

1 1 2

1 2

1

) (

} ) 1 ( ) 1 ( )

1 ( 2 {Z

p p

p p

p Z P P n

p1: Rate of remission patients expected in the controlled group = 50%,

p2: Rate of remission patients expected in the intervention group = 85%

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P = (p1 + p2)/2

Z(1- α /2): Reliability at 95% level (= 1,96)

1-: Sample power (= 80%)

The minimum sample size for each group n1 = n2 = 30 patients

Due to the fact that intervention for depression having high rate of out we have to recruit n1= 62 and n2 = 64 to make sure that we have at least 30patients to follow-up until the end of study which is the week of 30 (T30)

drop-2.3.3 Patients follow-up plan

- Intervetion group: after finishing treatment (6 weeks), patient will be

re-examined and given amitriptyline every two weeks, continuously for

30 weeks

- Controlled group: after finishing treatment (6 weeks), patient will be

re-examined and given amitriptyline every two weeks, continuously for

30 weeks

* All the important steps, such as screening at households, interview byPHQ-9, conducting BA sessions, are implemented by the study groupmembers who were carefully trained

2.3.4 Tools used in the study

- PHQ-9 (Appendix 5) – rate the severity of depression and monitor treatment response Define mild degree when PHQ-9 score from 10-14, moderate from 15-19, and severe from 20-27

- BADS-SF (Appendix 7) – assess behavioral change of depressed

patients after treatment by BA All the questions of BADS-SF can be

answered by 7 levels as following: 0 – not at all, 1 – very little, 2 – a little,

3 - moderate, 4 – a lot, 5 – very much, 6 - completely The higher of

BADS-SF is the higher of behavioral activation level BADS-SF scorenegatively correlate with depression severity, avoidance behavior,automatic depressed thoughts; positively correlate with reinforcepossibility, quality of life, active adapatation

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- Other questions to collect information about related factors:

demography, social-economic conditions…(Appendix 7)

- Assess the effectiveness of treatment on depression degree

The study assess the effectiveness of treatment on depression degreebases on the changes of PHQ-9 score The more decrease the PHQ-9 score

is the more effectiveness the treatment is, and vice versa

- Assess the effectiveness of treatment on depression behavior: bases on

the changes of BADS-SF score The more increase the BADS-SF score isthe more increase the level of activation behavior is, and vice versa

- Assess the effectiveness of treatment on remission, recovery, relapse, recurrence, bases on PHQ-9 score.

- Remission – a short period of time having no depression symptoms:

PHQ-9 < 5 since the point of T6 on

- Recovery – a period of remission lasting at least 6 months: PHQ-9 < 5

at the point of T30

- Relapse – the return of depressed symptoms, occuring in the

remission period, before recovery period: PHQ-9 > 9 again among 6months after having had PHQ-9 <5 at the point of T6

- Recurrence – the return of depressed symptoms in the period of

recovery: PHQ-9 at T6, T12 and T24 < 5, PHQ-9 at T30 > 9

2.4 Data entry and analysis

Data were entered and analyzed using EpiData 3.1 and STATA 12.0

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Chapter 3 STUDY RESULTS 3.1 Individual characteristics of study subjects

Table 3.1 Individual characteristics of study subjects

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Table 3.6 Mean of illness duration before study (week)

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3.3 Effectiveness of BA combined with amitriptyline in the treatment

of depression

3.3.1 Effectiveness in depression symptoms

Table 3.11 Differences of score changes of depressed mood symptoms at study times

Time

Controll group Intervention group Ranksum test n

Median of change

Median of change

T6-T0 30 -1,5 1.166 37 -2 1.112 1,9 0,06

T24-T0 21 -1 667,5 31 -2 710.5 2,2 0,03T30-T0 31 -1 1.321,5 37 -2 1.024.5 3,2 0,01

Table 3.12 Differences of score changes of loss of enterest/enjoyment

symptoms at study times

Median of change

Table 3.16 Differences of score changes guilty and unworthy ideas

symptoms at study times

Time

Control group Intervention group Ranksum test n

Median of

Table 3.23 Effectiveness of intervention on depression of the two group by

study times Thay đổi tỉ lệ tc

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3.3.5 Effectiness on depression degree

Table 3.25 Change of PHQ-9 mean of each study group at study times

relative to T0

Signed-rank test Time Effectiveness Control group Intervention group

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Table 3.26 Differences of changes of PHQ-9 mean between groups at

treatment times

Time

Control group Intervention group Ranksum

test n

Median of change

Median of change

T6-T0 30 -9,5 1.185 37 -12 1.093 2,1 0,04T12-T0 28 -11,5 906,5 33 -12 984,5 0,6 0,58T24-T0 21 -11 659,5 30 -13 666,5 2,2 0,03T30-T0 31 -9 1.284,5 37 -13 1.061,5 2,7 0,01

Table 3.27 Remission rate of each study group by treatment times

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Median of change

Table 3.36 Differences of changes of Avoidance subschale mean

between groups at treatment times

Median of change

R2

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Time Control group Intervention group z p

T6-T0 31 1 1.067,5 37 1 1.278,5 -0,03 0,98

Table 3.37 Diffences of average dose of amitriptyline between groups in

the treatment (mg/day)

5,7 0,00

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Chapter 4 DISCUSSION

4.1 Characteristic individuals of study subjects

The majority of depression ages are from 35 – 64, with the rate of 92%(Table 3.1) Mean age of the whole group is 49,7 ± 9,8 Our results aresimilar to the results of Tran Huu Binh (2007) in which the ages from 30 -

69 are predominant, with the rate of 89,41%

Predominant gender in this study is female and the ratio of female/male

is (Table 3.1) This result is also similar to the result of Tran Viet Nghi(female/male=3/1), more higher than the result of Kessler 1,7/1, Sadeghirad1,95/1, Sadock 2/1, Dimidjian 2/1, Pham Tu Duong 2,1/1 In explaining forthis phenomena Loewenthal (1995) hypothesize that: 1) Women are at aless powerful position than men leading them to have an adaptation stylethat make to be easier to develop depression like compliance, passitivity,and imppotence 2) The burden of housework and the care are all onwomen, in the mean time, men benefits from the marriage like the support,status, and the comfort 3) Men and women react differently with stress andpsychological sufferring Women can be more rumination than men Mencan be more reluctant than women in seeking the help when depressed As aresult, the rate of depression in men is lower than in female

The common level of education in this study is primary, and decrease bythe increase of education level Not high school graduation take themajority (65,4%) (Table 3.1) High school graduation is low (19,9%) Thisstudy results are similar to the results of some researchers such as TranQuynh Anh (2017), Amin, Akhtar-Danesh

The majority of marital status in this study is marriaged, currently livingwith their spouses (84,9%) Single, separation/divorce groups are theminorities in the study (Table 3.1) Our results are aso similar to the results

of Tran Huu Binh (2007) in that depressed patients have high rate ofmarriage (82,35%)

The common occupation in the study is free laborer (39,7%) and farmer(26,1%) (Table 3.1) Similar to the result of Tran Quynh Anh when finding84,2% depressed ptients are farmers

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4.2 MDD characteristics

4.2.1 Rate of patients having depression symptoms

Results of Table 3.2 show that the most common symptoms arefatiguability (100%), disturbed sleep (99,2%), depressed mood (93,7%),loss of interest and enjoyment (86,5%), pessimistic views of the future(84,9%), reduced appetite (81,8%), reduced self-esteem and self-confidence(81,0%) Three characteristic symptoms of depression which arefatiguability, depressed mood, loss of interest and enjoyment belong to thisgroup In the group of common symptoms of depression, disturbed sleepoccurs almost in all depressed patients (99,2%) The study results aresimilar to the results of Tran Huu Binh in that most of depression symptomsfatiguability 95,29%, loss of enjoyment 88,82%, reduced mood 85,88%,disturbed sleep 89,44%, low self-esteem 80% High rate of disturbed sleep,fatiguability show that when being depressed the patients in our study focusmore on somatic symptoms than emotional and cognitive symptoms(reduced concentration, pessimism, reduced self-confidence) This mayallow to propose a hypothesis that the depressed patients in our study payless attention on the impact of the cognition by depression This result issimilar the the statement of Simon (1999) that the complaints on somaticsymptoms is common in many countries

In the study, the most concerned issue is that the suicidal ideations arepretty high (30,2%) Results of Weissman and Amin also found that the rate

of depressed patients having death ideas or suicidal trend in the communityare high

4.2.2 Cognitive symptoms and related factors

In the Table 3.2, two symptoms that are high are reduce cofidence (81,0%), reduced concentration and attention (77,8%) Table 3.2showed that the rate of cognitive symptoms weren’t as high as othersymptoms These results are reasonable as in the ICD-10 cognitivesymptoms aren’t classified as characteristic symptoms of depression Theremaybe also another possibility that patients usually don’t pay attention totheir depreesion, and especially they don’t even pay attention to theircognitive symptoms of depression

self-esteem/self-4.2.3 Emotional symptoms and related factors

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