53

Any research starts with curiosity and question about a given phenomenon or a set of
phenomenon. Systematic attempts are made to explore analysis and understand the issues
under question through suitable, conceptual and methodological tools. The process of
inquiry and the analytical tools are a great extent relative to the specific domain of the
concern and the conceptual, methodological, heuristic and pragmatic goal of the research.

This chapter focuses on research paradigm and methodology adopted for the study.
Research methodology is a method to scientifically solve the research problem. In other
words, we can say that without methodological plan, no research can be possible.
Methodology requires a scientific insight for selection of a problem; formulating scientific
hypotheses, selection variable and their control etc. The present study was proposed to
investigate “Depression and quality of life in diabetic patients”.

Objectives of the study:

1. To measure the depression of diabetic patients.

2. To assess the quality of life of diabetic patients.
3. To know the difference in depression of type 1 and type 2 diabetic patients.
4. To know the difference in the quality of life of type 1 and type 2 diabetic patients.
5. To compare the depression and quality of life of male and female diabetic patients.
6. To know the relationship between depression and quality of life in terms of diabetes.

Hypotheses of the study:

Following hypotheses are formulated in respect of objectives of the study:

1. There would be significant difference in the depression of diabetics and non-diabetics.

2. Significant difference would be found in the quality of life of diabetics and non-
diabetics.
3. There would be significant difference in the depression of type- 1, type- 2 diabetics
and non- diabetics.
4. Gender of diabetics (type - 1, type -2) and non- diabetics will affect significantly on
the depression of participants.
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5. Female of three groups (type- 1, type- 2 diabetics & non- diabetics) will differ
significantly on the depression.
6. Male of three groups (type- 1, type- 2 diabetics & non- diabetics) will differ
significantly on the variable of depression.
7. There would be significant difference in the quality of life of type- 1, type -2 diabetics
and non- diabetic participants.
8. Gender of diabetics and non- diabetics would affect significantly on the variable of
quality of life of participants.
9. Female participants of three groups (type- 1, type- 2 diabetics & non- diabetic) will
differ significantly on quality of life variable.
10. Male of three groups (type -1, type- 2 diabetics & non- diabetics) will differ
significantly on the variable of quality of life.
11. Interaction between gender and types of groups (type -1, type- 2 diabetics & non-
diabetics) would be found significant on the depression of participants.
12. Interaction effect would be found significant between gender of participants and types
of groups (type -1, type- 2 diabetics & non- diabetics) on the variable of quality of
life.
13. Significant relationship would be seen between the variable of depression and quality
of life of studied participants.

3.1 Variables:

Independent variables

 Diabetes (Type 1 & Type 2)

 Gender of patients

Dependent variables

 Depression
 Quality of life
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3.2 Sample of the study:

The present study was comprised of 150 participants. Among them 50 patients were
selected from type -1 diabetics and 50 were selected from type- 2 diabetic population
and 50 participants were non-diabetics included in the sample. Each group of 50 further
divided into gender (25 males and 25 females) were included in the sample. Data was
collected from different clinics and hospitals of Muzaffar Nagar, Meerut, Saharanpur
and Bijnor districts of Uttar Pradesh state and Dehradun, Haridwar and Roorkee
districts of Uttrakhand state. All participants were selected by using purposive
sampling technique.

Inclusion criteria:

 Patients of diabetes, who don‟t have any chronic disease except diabetes (type-
1 & type-2 diabetes) were included in the sample.
 Participants of non-diabetes, who were neither patients of diabetes nor suffering
from any other chronic disease included in the sample.
 Between 30 to 50 years old participants were included in the sample.
 Participants included in the sample who were educated at least intermediate.
 Patients, who were suffering at least five years of disease were included in the
sample.

Exclusion criteria:

 Patients who are not interested to be a part of study were excluded from the study.
 Participants who were not fulfilling inclusion criteria, such as suffering chronic
disease other than diabetes, education level below intermediate, duration of
diabetes less than five years, were not included in the study sample.
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Sample Structure

Total subjects- 150

Type - 1 Type - 2 Non- Diabetics

Diabetics (50) Diabetics (50) (50)

Male (25) Female (25) Male (25) Female (25) Male (25) Female (25)

3.3 Procedure of Data collection:

For the purpose of the collecting data following procedure was adopted by researcher; first
of all, researcher collected the data of diabetic patients. For that, Diabetologist and
Endocrinologist were concerned by researcher for taking permission of data collection of
the patients under their treatment then concerned to the patients individually according to
their convenient time, date and place by denoting the purpose of the research. Researcher
assured them about keeping their results confidential. At first, researcher administrated the
BDI- II and clarified method of answering and instructions in detail to the patients. After
completing BDI-II researcher provide them the PGI- Quality of life inventory by given
instruction accordingly. For the control group, researcher followed the same procedure and
selected participants from the population as per need of sample.

3.4 Measurement Tools:

The following material were used for collecting data from the study population.
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Beck Depression inventory

It has been constructed by Aaron T. Beck which is used to assess the depression. The beck
depression inventory -second edition (BDI-II) is a 21- item self-report instrument for
measuring the severity of depression. BDI- II was developed for the assessment of
symptoms corresponding to criteria for diagnosing depressive disorders listed in American
Psychiatric Associations Diagnostic and Statistical Manual of Mental Disorder.

Development

The Beck Depression Inventory- Second Edition (BDI II) is an instrument for measuring
the severity of depression in adults and adolescents aged 13 years and older. This version
of the inventory (BDI-II) was developed for the assessment of symptoms corresponding to
criteria for diagnosing depressive disorder listed in the Diagnostic and Statistical Manual
of Mental Disorders- Fourth Edition (DSM-IV;1994). After 35 years of experience and
research with the BDI, recognized that the time was propitious for revising the instrument
and for modernizing the amended Beck Depression Inventory (BDI-IA; Beck, Rush, Shaw
& Emery, 1979).

The BDI-IA replaced the original instrument (BDI) that had been developed by Beck,
Ward, Mendalson, Mock and Erbaugh (1961). For the new, revised version (BDI-II), four
items (Weight Loss, Body Image Change, Somatic Perception and Work Difficulty) were
dropped and replaced by four new items (Agitation, Worthlessness, Concentration
Difficulty and Loss of Energy) in order to index symptoms typical in severe depression or
depression warranting hospitalization.

Two items were changed to allow increase as well as decrease in appetite and sleep. Many
of the statements (or alternatives) used in rating the other symptoms were reworded.
Unlike the BDI-IA, the BDI-II constitutes a substantial revision of the original BDI.

Item Development

Beck and his associates began the plot work for the BDI-II in 1994. Specific items that
addressed DSM-IV depression criteria and had not been included in the BDI-IA such as
Agitation, Worthlessness, Concentration Difficulty and Loss of Energy were constructed
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and plot tested along with other BDI-IA items, whose statement options were partially
reworded for clarity. The Insomnia and Loss of Appetite items were significantly rewarded
to reflect both increases and decreases in sleep and appetite respectively. The weight loss
item was not included in the pilot study instrument. In order to reduce the 27 item pilot-
study instrument to the resulting 21 item version, Beck and associates conducted a series of
item and factor analysis with response of 193 psychiatric outpatients diagnosed with
various psychiatric disorders.

Table 1.1 summarizes the change between the BDI-IA and the final version of the BDI-II
with respect to the types of symptoms and the number of statements or options that were
reworded. As the data in Table 1.1 indicate, only three items from the BDI-IA were not
reworded; Punishment, Suicidal ideas and Loss of Libido. In some instances, the BDI-IA
labels for the reworded items were also changed for the BDI-II, for example, the label self-
accountant was changed to Self-Criticalness, which represents the alternative statements
better than the previous label. As previously mentioned, Body image Change, Weight
Loss, Somatic Preoccupation and Work Difficulty were replaced by Agitation,
Worthlessness, Concentration Difficulty and Loss of Energy. The insomnia item now asks
about both sleep loss and increased and was renamed Changes in Sleep Pattern. The Loss
of Appetite item now addresses both increase and decrease in appetite and was renamed
Change in Appetite. Additional clinical implications were also attached to some items. For
example, the Social Withdrawal item in the BDI-IA which had stressed only interpersonal
relationships, now includes both people and activities as the BDI-II‟s Loss of Interest item.

Table 1.1 Summary of item Content Differences Between the BDI-IA and the BDI-II

BDI-IA Items BDI-II Items

Labels Change Label Change

1.Sadness 1.Sadness Two option reworded

2.Pessimism 2.Pessimism Three option reworded
3.Sense of Failure 3.Past Failure Three option reworded
4.Self-Dissatisfaction 4.Loss of Pleasure Four option reworded
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5.Guilt 5.Guilt Feelings One option reworded

6.Punishment 6.Punishment Feelings Zero option reworded
7.Self-Dislike 7.Self-Dislike Four option reworded
8.Self Accusations 8.Self Criticalness Three option reworded
9.Suicidal Ideas 9.SucidalThought/ Zero option reworded
Wishes
10.Crying 10. Crying Four option reworded
11.Irritability Moved to BDI 11. Agitation* New item and option
II item 17
12.Social Withdrawal 12. Loss of Interest Four option reworded
13.Indecisiveness 13. Indecisiveness Four option reworded
14.BodyImage Item dropped 14.Worthlesness* New item and option
Change
15.Work Difficulty Item dropped 15. Loss of Energy* New option reworded
16. Insomnia 16.Lossin Sleeping Four option reworded
Pattern
17. Fatigability Moved to BDI- 17.Irritability Four option reworded
II item 20
18.Loss of Appetite 18.Change in Four option reworded
Appetite
19.Weight Loss Item dropped 19.Concentration New item and option
Difficulty
20.Somatic Item dropped 20.Fatigue Four option reworded
Preoccupation
21. Loss of Libido 21.Loss of Interest in Zero option reworded
sex
Note BDI-IA Amended BDI Beck depression inventory (Beck and Steer, 1987); BDI-II=
Beck Depression Inventory-Second Edition.

*New item in BDI-II

Critical use
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The BDI-II is an assessment of the severity of depression in psychiatrically diagnosed

adults and adolescent patients aged 13 years and older. The BDI-II was developed as an
indicator of the presence and degree of depressive symptoms consistent with the DSM-IV,
not as an instrument for specifying a critical diagnosis. The BDI should be used
continuously as the sole diagnostic measure because depression may accompany a variety
of diagnostic disorders ranging from panic disorder to schizophrenia.

Although the BDI-II may be easily administered and scored by paraprofessionals, scores
should be interpreted only by professionals with appropriate clinical training and
experience. User should be familiar with the guideline for test utilization established by the
American Psychological Association in Standards for Educational and Psychological
training (1985). Because depression may be associated with suicidal risk in psychiatric
patients, it is important that the clinical reviewing the BDI-II data be able to respond to a
patient‟s depression by having available a full range of appropriate therapeutic
interventions or referral mechanism. Moreover, the clinician should pay special attention to
the responses to item 2 (Pessimism) and item 9 (Suicidal thoughts or wishes) as indictor of
possible suicidal risk.

Administration and scoring

Testing Condition

The BDI-II presents few difficulties with respect to test administration and is unfriendly.
The testing environment must provide the examinee with sufficient illumination for
reading and be quiet enough to facilitate adequate concentration. Obviously, the test
administration must determine beforehand whether or not a patient can read or comprehend
the BDI-II‟s item content. The test item may be read aloud by the examiner for individual
with reading difficulties or problem in concentration.

Administration Time

In general, the BDI-II requires between 5-10 minutes to complete. This is comparable to
the average amount of time that is usually needed to complete the BDI-IA (Bell, Archer &
Imhof, 1994). Patients with severe depression or obsessional disorders often take longer
than average.
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Self-Administration:

The directions for the BDI-II differ from those given for the BDI-IA. For the BDI-IA,
respondent is asked to endorse the most characteristic statement covering the time frame of
the “past week, including today”. Note that the time frame of the BDI-II was extended to 2
weeks in order to be consistent with DSM-IV criteria for major depression.

The following self-administration instruction appear on BDI-II Record Form:

This questionnaire consists of 21 groups of statements. Please read each group of statement
carefully and then pick out the one statement in each group that best describe the way you
have been feeling during the past two weeks, including today. Circle the number beside the
statement you have picked. If several statement in the group seem to apply equally well,
circle the highest number. Be sure that you do not choose more than one statement for any
group, including item 16 (Change in Sleeping Pattern) and item 18 (Change in Appetite).

Oral Administration

As with the BDI-IA, the BDI-II can be administered orally. In such case, there instructions
are suggested:

This is a questionnaire. On the questionnaire are group of statements. I will read a group of
statements, then I would like you to pick out the one statement in each group that best
describes the way you have been feeling during the past two weeks, including today.

Than hand the copy of BDI-II to the examinee and say,

Here/s a copy for you so that you can follow along as I read

Now, which of the statement in the first group and then say -

Now, which of the statements best describes the way you have been feeling during the past
two weeks, including today?

If the examinee indicates his or her choice with the number of the statement, read back the
statement corresponding to the number given by the examinee to confirm the statement
selected. After it is apparent that the examinee understands the rating system, the
numerical responses may be sufficient to indicate his or her choice. If the examinee
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indicates that two or more statements fit the way, he or she feels record the higher of the
two ratings.

Generally, the interviewer should continue to read about the statements composing each
group. Sometimes, however, the examinee will take the initiative and silently read the item
statements ahead of the tester and start giving responses spontaneously. If the examinee is
alert and knowledgeable, allow him or her to proceed in this manner. If necessary, tactfully
encourage the examinee to reflect sufficiently before making a choice.

Carefully inspect all of the ratings at the end of the testing to ensure that no items have
been skipped or left blank, especially questions about change in sleep and appetite (item 16
& 18). Ask the examinee to answer any outlined items. If a patient explained that she or he
is unsure about which alternative is best for an item tell them to select those alternatives
that fit best and then choose the statement with the higher score.

Scoring

The BDI-II is scored by summing the ratings for the 21 items. Each item is used on 4-point
scale ranging from 0-3. If an examinee has made multiple endorsements for an item, the
alternative with the highest rating is used. The maximum total score is 63.

Special attention must be paid to the correct scoring of the Changes in Sleeping pattern
(item 16) and Change in Appetite (item 18) items. Each of these items contain seven
options rated, in order, as 0,1a, 1b, 2a, 2b, 3a, 3b to differentiate between increases or
decreases in behaviour or motivation. If a higher rated is chosen by respondent, the
presence of an increase or decrease in either symptom should be clinically need for
diagnostic purposes.

The purpose of developing a screening instrument for major depression for clinical
purposes, sensitivity of the test was considered to be more important than specificity. That
is, the clinician would want to adopt relatively lower threshold for detecting depression in
order to decrease the probability of any false negatives. Therefore, the cut sore guidelines
below are suggested for total scores of patients diagnosed with a major depression.
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Total scores Range

0-13 Minimal
14-19 Mild
20-28 Moderate
29-63 Severe

The four groups from the University of Pennsylvania sample described previously obtained
the following mean scores; Non- depressed, M= 7.65, SD=5.9; mildly depressed M =19.14,
SD =5.7; moderately depressed M= 27.44, SD= 10.0; and severely depressed M=32.96,
SD= 12.0.

The decision to use different cut scores for the BDI-II must be based on the unique
characteristic of the sample and the purpose for using the BDI-II. The practitioner is
cautioned that of the purpose is to detect the maximum number of persons with depression,
then the cut score threshold should be lowered to minimize the false negatives. Although
the number of false positive will increase, this method may be useful when screening for
possible cases of depression.

Reliability of the inventory

Internal consistency of Beck depression inventory II included a sample of 500 outpatients

and 120 college student, the coefficient alpha of BDI- II for outpatient was 0.92 and for the
120 college student 0.93. Beck et al. (1988) found that the BDI-IA had a mean coefficient
alpha of .86. All of the correlated item-total correlations for the 21 BDI-II items for both
the outpatients and college student sample were significant beyond the .05 level. And over
period of one week approximately the test re test reliability coefficient for a subsample of
26 Philadelphia outpatients were also high 0.93 (p, < .001).
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Validity of the inventory

Several different types of analyses were conducted to estimate the convergent validity of
the BDI-II. First between BDI-AI and BDI-II scores. The correlation between BDI-AI and
BDI-II was .93(p<0.01) through convergent validity BDI –II is positively (p<00.1) related
to both the beck hopelessness scale (BHS; Beck& Steer,1988) (r = .68) and the scale for
suicide ideation (SSI; Beck, Kovacs, & Weissman,1979) (r=.37) and the correlation
between the beck anxiety inventory (BAI; Beck & Steer, 1990) and BDI-II scores was .60
(p<0.01). Convergent and discrimination validity of the BDI- II highly correlated (r = .71)
with the Hamilton Psychiatric rating scale for depression (HRSD; Hamilton,1960).

PGI- Quality of life:

The PGI Quality of Life Scale was used for the assessment of Quality of Life. The scale
revised in Hindi by Dr. A.C. Moudgil, Dr. S.K. Verma & Ms. Kuldipkaur. The PGI
Quality of Life Scale is a 26-items scale measuring quality of life the age range of 20 to 60
years. Each item has five level of responses (the score of each item ranges from 1 to 5, and
the total obtained scores range 26 to 130), that takes about 15-20 minutes to be performed.
In the scale, the higher score shows the greater quality of life perceived by the
subject/group.

Standardize:

This scale was standardized on 100 adults in the age range of 20 – 60 years (M = 29.61 &
SD = 9.62 years),75 of whom were males of all education and varied income (150 to
10,500) groups. These subjects covered the entire range of scores as shown below:

Norms: N = 100, M = 93.60, SD = 14.89

Range of score = 26 to 130

Scoring:

The scoring of quality of life scale is very easy in nature. The scale can be scored easily
with reference to the scores obtained for each item separately. Each item had five
alternatives answers and subject has to put a right tick at anyone out of the five column.
Scoring of these five alternatives follow a system of 1, 2, 3, 4, and 5 respectively. The
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addition of all the scores obtained on each item would be the total quality of life scores of
the subject. Higher score, greater was the quality of life perceived by the subject.

Reliability of the Scale:

The reliability of the PGI Quality of Life is determined by the following methods:

 Inter-rate reliability = .89

 Inter-scorer reliability = .99
 Test-retest reliability = .79
 Split-half reliability = .72
 Self-other rating = .81

All these correlations are significant at .01 level. Thus, the scale has satisfactory reliability.

Validity of the Scale:

Face validity was established using expert clinical psychologists, who unanimously
recognized it as a test of quality. For concurrent validity, the PGI quality of life scale was
administrated to 15 subjects along with a number of other well standardized scale
mentioned earlier. Results are given below:

Divergent validities were established against the following questionnaires

1. PGI health questionnaire N-2

(a) Neuroticism = -.26 n.s.
(b) Lie = -.02 n.s.
2. PGI locus of control scale = .24 n.s.
3. Socio-economic status scale = .31 n.s.

Convergent validities were obtained against the criterion measure of

4. PGI achievement value index = .57 p < .05

5. PGI well-being scale = .54 p < .05

The expected results were obtained. The concept of quality of life is independent of degree
of neuroticism, and locus of control (internal/external). It is also independent of socio
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economic status of the person. It is also unaffected by the social desirability type of
response bias (tendency to lie). On the other hand, as expected, it overlaps (but is not
identical) with achievement value and subjective feelings of well-being. Both divergent
and convergent validities are thus established. In addition, the scale scores were unrelated
to the subject‟ age (r=.46, n.s.) and education (r=.46, n.s.). In other words, it can be used
with all education groups and all age levels (20 to 60 years‟ age group at least as used in
this study). Thus, PGI- quality of life scale in Hindi is a standardized, brief, simple,
reliable and valid scale with local norms. It is not affected by age, education, socio-
economic status and social desirability response set.

3.5 Statistical Treatment

Obtained data was analyzed by using Mean, SDs, Independent „t‟ test, ANOVA (one way
& 3×2), Pearson correlation and Regression analysis. Apart from that, graphical
representation of results also done by researcher. All the calculation has been done using
IBM SPSS version 26.