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Depression and Pain Impair Daily Functioning and Quality of Life in Patients with Major Depressive Disorder Ching-Hua Lin, Yung-Chieh Yen, Ming-Chao Chen, Cheng-Chung Chen

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Journal of Affective Disorders

Received date: 19 October 2013 Revised date: 16 March 2014 Accepted date: 17 March 2014 Cite this article as: Ching-Hua Lin, Yung-Chieh Yen, Ming-Chao Chen, ChengChung Chen, Depression and Pain Impair Daily Functioning and Quality of Life in Patients with Major Depressive Disorder, Journal of Affective Disorders, http: //dx.doi.org/10.1016/j.jad.2014.03.039 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Depression and Pain Impair Daily Functioning and Quality of Life in Patients with Major Depressive Disorder

Ching-Hua Lin, M.D., Ph.D.1, 2; Yung-Chieh Yen, M.D., Ph.D.3, 4; Ming-Chao Chen, M.D.1, 2; Cheng-Chung Chen, M.D., Ph.D.1, 2 1

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan

2

Department of Psychiatry, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan

3

Department of Psychiatry, E-Da Hospital, Kaohsiung, Taiwan

4

School of Medicine, I-Shou University, Kaohsiung, Taiwan

Running Title: Depression and pain impair function and quality of life Correspondence address: Cheng-Chung Chen, M.D., Ph.D.; Kaohsiung Municipal Kai-Syuan Psychiatric Hospital; 130, Kai-Syuan 2nd Rd., Ling-Ya District, Kaohsiung 802, Taiwan Tel: +886-7-751-3171 ext. 2301; Fax: +886-7-716-1843 Email: [email protected]

Abstract Background: Depression and pain frequently occur together. The objective of this study was to investigate the effects of depression and pain on the impairment of daily functioning and quality of life (QOL) of depressed patients. Methods: We enrolled 131 acutely ill inpatients with major depressive disorder. Depression, pain, and daily functioning were assessed using the 17-item Hamilton Depression Rating Scale, the Short-Form 36 (SF-36) Body Pain Index, and the Work and Social Adjustment Scale. Health-related QOL was assessed using three primary domains of the SF-36: social functioning, vitality, and general health perceptions. Pearson’s correlation and structural equation modeling were used to examine relationships among the study variables. Five models were proposed. Results: In all, 129 patients completed all the measures. Model 5, both depression and pain impaired daily functioning and QOL, was the most fitted structural equation model (χ2 = 9.2, df = 8, p = 0.33, GFI = 0.98, AGFI = 0.94, TLI = 0.99, CFI = 0.99, RMSEA = 0.03). The correlation between pain and depression was weak (r = -0.27, z = -2.95, p = 0.003). Limitation: This was a cross-sectional study with a small sample size. Conclusion: Depression and pain exert a direct influence on the impairment of daily functioning and QOL of depressed patients; this impairment could be expected

regardless of increased pain, depression, or both pain and depression. Pain had a somewhat separate entity from depression.

Key words: major depressive disorder; pain, daily functioning; health-related quality of life; structural equation modeling

1. Introduction Depression and pain frequently occur together. An international study (Simon et al., 1999) demonstrated that somatic symptoms occurred in 69% of patients with major depressive disorder (MDD) at a primary care center. Most of the somatic symptoms were pain-related. In another study of 150 depressed inpatients,(Corruble and Guelfi, 2000) 92% reported at least one pain symptom, and 76% complained of the presence of multiple pain symptoms. According to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV),(APA, 1994) pain is not a diagnostic symptom in MDD. Pain complaints are included only as associated features. Furthermore, pain is less or not emphasized in standard measures of depression severity, such as the 17-item Hamilton Rating Scale for Depression (HAMD-17) (Hamilton, 1960) and the Montgomery-Asberg Depression Rating Scale.(Montgomery and Asberg, 1979) However, a growing body of evidence suggests that pain and depression may operate

within similar areas of the brain that regulate both mood and the affective components of pain.(Giesecke et al., 2005) Some of the overlap between depression and pain can be explained biologically, in that pain and depression appear to share common pathways and neurotransmitters.(Bair et al., 2003; Fields, 2000) The nature of the relationship between depression and pain is still inconclusive. Some research indicates that there is a causal relationship between the two.(Fishbain et al., 1997) Others suggest that depression and pain are indistinguishable and that chronic pain is really a form of depression.(Blumer and Heilbronn, 1982) Three theories have been postulated to explain the relationship between pain and depression.(Bair et al., 2003; Lepine and Briley, 2004) The first theory suggests that pain is caused by depression.(Larson et al., 2004; Leino and Magni, 1993; Magni et al., 1994; Pine et al., 1996) The second theory proposes that depression is caused by pain.(Dohrenwend et al., 1999; Nicassio and Wallston, 1992; Patten, 2001) The third theory suggests that depression and pain may interact bidirectionally.(Gureje, 2007; Hotopf et al., 1998; Von Korff and Simon, 1996) A common definition of quality of life (QOL) focuses overall satisfaction with life and general sense of personal well-being.(Spilker, 1990) Depression scales, such as HAMD-17, do not cover important domains of QOL. QOL measurement can capture differences, not shown in HAMD-17. QOL assessment made it possible to compare

the impact of different conditions (e.g., depression symptoms and pain).(De Fruyt and Demyttenaere, 2009) MDD is associated with impairment of daily functioning and quality of life (QOL). (APA, 2010; Greer et al., 2010; Pyne et al., 1997; Rapaport et al., 2005; Trivedi et al., 2006) Therefore, the APA (APA, 2010) guideline suggests that a complete psychiatric assessment should include daily functioning and QOL. Besides depression, pain also has negative effects on a patient’s daily functioning and QOL.(Gureje et al., 1998; Husain et al., 2007; Lepine and Briley, 2004; Mavandadi et al., 2007; Ohayon and Schatzberg, 2010; Smith et al., 2001; Sullivan et al., 2001) Depressed patients with pain have been reported to be associated with poor depression outcomes, including more severe depression, poorer QOL, and daily functioning. (Demyttenaere et al., 2006; Gambassi, 2009; Lee et al., 2009; Lin et al., 2003; Munoz et al., 2005; Ohayon and Schatzberg, 2010; Von Korff et al., 1992) Pain patients with MDD have poor QOL than those without depression.(Elliott et al., 2003) As mentioned above, pain and depression are considered to have overlapping underlying mechanisms. The different level of impairment in daily function and QOL contributed by depressive symptoms, pain, or depressive symptoms plus pain should be investigated. However, most previous studies that examined a single issue and its effect on patients’ QOL or daily functioning may not have been sufficient to test a number of inter-related problems simultaneously. Structural equation modeling (SEM)

can offer a framework to investigate the relationship among several variables simultaneously. SEM contains modeling of causal relationships among variables, examination of direct and indirect effects, modeling of variables as latent or measured, and testing of competing models. (Bollen, 1989; Kline, 2011) The goal of this study was to construct a set of viable models using SEM to examine the relationships between depression, pain, daily functioning, and QOL for hospitalized patients with MDD.

2. Method 2.1. Subjects This study was a post-hoc analysis of our previous clinical trial. The trial was approved by Kai-Syuan Psychiatric Hospital’s institutional review board, and written informed consent was obtained from the participants. The trial was registered on clinical.trials.gov (Identifier number: NCT01075529). Details of the patient sample are presented elsewhere.(Lin et al., 2011) In brief, subjects were recruited from Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan. Participants were considered eligible if they were new inpatients undergoing acute treatment, between 18 and 70 years old, and physically healthy with all laboratory parameters within normal limits (including electrocardiography and chest X-ray), and

had been diagnosed as having MDD using the Structured Clinical Interview for DSM-IV.(First, 1997) The exclusion criteria were: a HAMD-17 < 18 and a Clinical Global Impression of Severity (CGI-S) (Guy, 1976) < 4 at baseline, psychotic depression, bipolar I or II disorder, schizophrenia or any other psychotic disorder, a DSM-IV diagnosis of substance abuse or dependence (including alcohol) within the past 6 months, mental disorders due to organic factors, severe cognitive impairment, initiating or ending formal psychotherapy within 6 weeks prior to enrollment, treatment-resistant depression (defined as a lack of response to 2 or more adequate courses of antidepressant treatment), a history of poor response to fluoxetine (20 mg/day for ≥ 4 weeks), a history of electroconvulsive therapy, and pregnancy or lactation. 2.2. Procedures and assessments After a washout period of at least 72 hours, the patients had to complete a pre-trial assessment. Depression was assessed at baseline by board-certified psychiatrists using the HAMD-17. The intraclass correlation coefficient of reliability was 0.95 between the raters. Pain was measured by the Body Pain Index (BPI) of the Medical Outcomes Study Short-Form-36 (SF-36).(Bair et al., 2004; Karp et al., 2005; Ware and Sherbourne, 1992) The BPI consists of 2 items that measure: 1) pain severity (Item 7), ranging from 1 (none) to 6 (very severe); and 2) pain interference (Item 8), ranging

from 1 (not at all) to 5 (extreme). Pain interference is a separate construct (i.e., the evaluative-cognitive dimension) different from the sensory dimension of pain (i.e., pain severity). Their scoring of pain severity and pain interference is different. Scores of items 7 and 8 should be recoded to final scores of items 7 and 8 according to the scoring instructions of the SF-36.(Ware, 2000) The BPI is computed by summation of final scores of item 7 and item 8 then converted to a 0-100 scale. A higher score means less pain. This approach has been used previously.(Karp et al., 2005) Daily functioning was assessed using the Work and Social Adjustment Scale (WSAS) (Mundt et al., 2002) at baseline. The WSAS is a self-rated scale that consists of 5 Likert scales that measure an individual’s perception of work and social functioning, with higher scores representing greater impairment of daily functioning. Each item is scored from 0 (not affected at all) to 8 (severely affected), with a maximum total score of 40.(Mundt et al., 2002) At baseline, health-related QOL was assessed by 3 primary domains of the SF-36,(Ware and Sherbourne, 1992) including social functioning (SF), vitality (VT), and general health perceptions (GH).(Bair et al., 2008) These 3 domains have been used in a previous study.(Bair et al., 2008) SF-36 has 2 primary-factor analytic components, the physical component summary (PCS) and the mental component summary (MCS). Only 3 domains were used, as body pain is included in the PCS.(Teh et al., 2009) A lower score represents a poorer health-related QOL. The

independent variables selected for use in this study were depression (i.e., HAMD-17 score) and pain (i.e., BPI score). Two others were age (Campbell et al., 2003) and sex.(Dowdy et al., 1996) The dependent variables were daily functioning (i.e., WSAS score) and health-related QOL (i.e., SF score, VT score, and GH score). 2.3. Statistical analysis Data were analyzed using SPSS version 17.0 for Windows and the Analysis of Moment Structures (AMOS) version 17 (SPSS Inc., Chicago, IL, USA). Statistical significance was set at p < 0.05. Correlations between measured variables were analyzed by Pearson’s correlation coefficients. Based on the possible relationships, we proposed 5 competing SEM models for further testing. In model 1, depression alone impaired daily functioning and QOL. In model 2, pain alone impaired daily functioning and QOL. In model 3, depression, mediated by pain, impaired daily functioning and QOL. In model 4, pain, mediated by depression, impaired daily functioning and QOL. In model 5, both depression and pain impaired daily functioning and QOL. SEM using AMOS was designed to confirm these 5 competing models. SEM is an extension of multiple regression and path analysis. Unlike multiple regression models, SEM provides a framework for simultaneously examining the relationships (i.e., cause-effect or correlation) among measured variables and latent variables.(Streiner, 2006) SEM also allows the examination of both the direct and

indirect effects of one variable on another. A latent variable is a construct which is difficult or impossible to measure directly, but can be measured through its effect on measured variables, such as questionnaires or laboratory data. Combining measures of a latent variable reduces measurement error.(Borsboom et al., 2003) The variables were connected by either bi-directional arrows expressing association (i.e., correlation) or unidirectional arrows expressing predictability (i.e., regression). In this study, impairment of daily functioning and QOL was constructed by a combination of daily functioning impairment (i.e., WSAS score) and QOL impairment (i.e., SF score, VT score, and GH score) as a latent variable (abbreviated as “impairment”). Impairment was directly influenced by depression (i.e., HAMD-17 score), pain (i.e., BPI score), age, and sex. Maximum-likelihood estimation was used to assess the fitness of the 5 competing models. The null hypothesis for SEM was that the model fits the data. The χ2 statistic provides a test of the null hypothesis. The higher the probability associated with χ2, the closer the fit between the hypothesized model and the perfect fit.(Bollen, 1989) If the p value is larger than 0.05, used by convention, the model does not differ significantly from the data and is accepted. The criteria for goodness-of-fit were as follows: Goodness-of-Fit Index (GFI) > 0.90, Adjusted Goodness-of-Fit Index (AGFI) > 0.90, Tucker-Lewis Index (TLI) > 0.95,(Bentler and Bonett, 1980) Comparative Fit

Index (CFI) > 0.90,(Bentler, 1990) and Root Mean Square Error of Approximation (RMSEA) < 0.08.(Bollen and Long, 1993; Kline, 2011) Estimates of path coefficients represent the strength of the path between 2 variables, and were calculated using standardized regression coefficients (i.e., β values).

3. Results 3.1. Clinical variables A total of 131 acutely ill inpatients with MDD were enrolled. However, SEM is limited to complete cases. In all, 129 (98.3%) of the 131 patients that completed all clinician-rated and self-rated assessments and measures at baseline entered the SEM analysis. Except for age and sex, all the measured variables were significantly related to each other statistically (Tables 1 and 2). Therefore, age and sex were not included in subsequent analyses. 3.2. Model validation Model 1, which assumed that depression alone impaired daily functioning and QOL, did satisfy all indices of goodness-of-fit, in that it explained 31% (R2) of variance of impairment in daily functioning and QOL. Model 2, which assumed that pain alone impaired daily functioning and QOL, also satisfied all indices of goodness-of-fit, in

that it explained 24% (R2) of variance of impairment in daily functioning and QOL. Model 3, which assumed that depression impaired daily functioning and QOL was mediated by pain, did not satisfy the non-significant χ2 test (χ2 = 34.0, df = 9, p < 0.001). Model 4, which assumed that pain impaired daily functioning and QOL was mediated by depression, also did not satisfy the non-significant χ2 test (χ2 = 24.9, df = 9, p = 0.003). Models 3 and 4 should therefore be rejected. Model 5, where both depression and pain that were interrelated impaired daily functioning and QOL, did satisfy the goodness-of-fit, in that explained 43% (R2) of variance of impairment in daily functioning and QOL. Depression (β = 0.46, z = 4.47, p < 0.001) made a greater contribution to impairment in daily functioning and QOL than pain (β = -0.36, z = -3.73, p < 0.001). All path coefficients in models 1, 2, and 5 were significant at the level of p < 0.001 (Table 3). The variance of impairment (R2) explained by model 5 was larger than in model 1 or model 2. Model 5 proved to be the best model because it permitted simultaneous investigation of the impairment effect of depression and pain on the latent variable. Figure 1 denotes the significant pathways of model 5. The e1, e2, e3, e4, and e5 indicate the error terms. The error term represents variance unexplained by independent variables (i.e., HAMD-17 score and BPI score).

4. Discussion The mean score of baseline BPI ± SD of our patients was 46.3 ± 26.7 (Table 1). The mean score of BPI ± SD in the general population is reported to be 50.7 ±16.3.(Maglinte et al., 2012) This means that depressed patients have more severe pain than the general population. The major finding of this study is that depression and pain have a direct effect on the impairment of daily functioning and QOL of depressed patients. In model 1, the greater the depression (β= 0.56, z = 5.01, p < 0.001), the greater the impairment of daily functioning and QOL. In model 2, as pain severity worsened (β= -0.49, z = -4.36, p < 0.001), daily functioning and QOL were adversely affected. In model 5, the greater the depression symptoms and pain, the greater was the impairment of daily functioning and QOL. Models 3 and 4 were rejected. These indicated that there was no specific cause-effect relationship between pain and depression in impairing daily functioning and QOL. Model 1 (R2 = 0.31) and model 2 (R2 = 0.24) showed that either depression or pain can lead to impairment of daily functioning and QOL. Depression appeared to impair daily functioning and QOL more than pain. Model 5 (R2 = 0.43) indicated that pain and depression had an additive effect on the impairment of daily functioning and QOL.(Bair et al., 2003) Impairment of daily functioning and QOL could be expected regardless of increased

pain, depression, or both pain and depression. Physicians must be able to recognize this comorbidity and optimal treatment for depressed patients with pain. Pain has been regarded as an integral part of depression because of the very high symptom occurrence between pain and depression.(Lepine and Briley, 2004) Pain and depression have been reported to have a reciprocal relationship, in that each heightened the severity of the other; however, the correlation was weak (r = -0.27, z = -2.95, p = 0.003). This weak relationship has been previously reported.(Averill et al., 1996; Fava et al., 2004; Jann and Slade, 2007; Ohayon and Schatzberg, 2010; Reichborn-Kjennerud et al., 2002; Tait et al., 1990) Therefore, pain should be regarded as a somewhat separate entity from depression under the current description of depressive syndromes. When selecting treatment for patients with depression, physicians have to decide whether pain is present, and they must use treatments that target both the depression and pain. Physicians often use antidepressants as well as nonpharmacologic therapies, such as cognitive-behavioral therapy,(Vowles et al., 2007) relaxation training, hypnosis, and physical exercise.(HMS, 2010; Rooks et al., 2007) Serotonin-norepinephrine reuptake inhibitors (SNRIs) have proven efficacy for treating pain.(Sultan et al., 2008) This remedy should be expected to have better outcomes.(Trivedi, 2004) The use of SEM was the strength of this study. SEM permits simultaneous

evaluation of the effect of depression and pain on the latent variable (i.e., impairment of daily functioning and QOL) within the model. Unlike linear regression analysis, multiple dependent variables are permitted in SEM. The complexity of the interrelationships of these variables can consequently be better illustrated. However, the findings of this study must also be seen within the limits of the method of interpreting the results. First, this was a cross-sectional study. Second, 15 cases per measured variable in SEM is regarded as reasonable.(Benter and Chou, 1987; Stevens, 2009) The current sample size (n = 129) was too small to perform SEM analysis with too many variables. There may be other models with larger case numbers that would fit the data better than this model. Third, this trial used specific scales to measure depression, pain, daily functioning, and QOL. The HAMD-17 assesses different aspects of major depression. Using the total score can also make interpretation difficult as it contains depression, sleep, anxiety, appetite, pain, and other items. To exclude this difficulty of interpretation, using core mood subscale with 5 items derived from the HAMD-17 has been used to represent the “core depressive symptoms”. (Lee et al., 2009) These 5 items are: item 1- depressed mood, item 2feelings of guilt, item 3- suicide, item 7- work and activities, item 8 -psychomotor retardation. In model 5, if we change the HAMD-17 to core mood subscale. There is no significant relationship between core mood subscale score and BPI score (p =

0.62). This new model also fit well by indices (χ2 = 14.3, df = 9, p = 0.11, GFI = 0.97, AGFI = 0.92, TLI = 0.94, CFI = 0.97, RMSEA = 0.07). All the path coefficients are statistically significant at the level of p < 0.001 (data and figure not shown). The variance of impairment in daily functioning and QOL explained by new model (R2 = 0.46) was larger than by model 5 (R2 = 0.43). Furthermore, core mood and pain were different aspects. They affected the impairment of daily functioning and QOL independently. Other scales which measure such variables may yield different results. Fourth, our sample was comprised of the most severely depressed patients who required hospitalization. Thus, we cannot be certain to what extent our results can be generalized to outpatients. Fifth, pain was evaluated by self-rated items from the SF-36, and these pain items do not adequately assess the pain site, the qualities of pain such as pain subtypes, and personal attitudes and beliefs about pain.(Karp et al., 2005) However, since pain is a subjective feeling, self-reports of pain are commonly regarded as accurate.(Ohayon, 2004) Further research to explore the generalizability of our findings is desirable. Even with the limitations of these results, we still feel it is important for clinicians to understand the relationship between depression and pain, and their synergistic impact on daily functioning and QOL.

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Table 1 Sex, mean age, and the scale mean scores of inpatients with major depressive disorder at baseline (n = 129). Measured Variables Sex-male, % Age, mean (SD), y

Distribution 29 (22.5) 45.0 (11.1)

HAMD-17 a score, mean (SD) 31.4 (6.6) (higher scores mean more severe depression) SF-36 b Body Pain Index (BPI) score

46.3 (26.7)

(higher scores mean less pain) WSAS c score, mean (SD)

30.6 (9.5)

(higher scores mean poorer functioning) Health-related quality of life social function score (SF), mean (SD)

33.7 (23.0)

vitality score (VT), mean (SD)

23.1 (19.4)

general health perceptions score (GH), mean (SD)

27.3 (21.6)

(lower scores mean poorer quality of life) a

HAMD-17: 17-item Hamilton Depression Rating Scale

b

c

SF-36 = Medical Outcomes Study Short-Form 36

WSAS: Work and Social Adjustment Scale

Table 2. Pearson correlation coefficient matrix of the measured variables (N = 106)

X1

X2

X3

X4

X5

X6

X7

X1

HAMD-17 score

1

X2

SF-36 BPI score

-0.27**

1

X3

WSAS score

0.41**

-0.25**

1

X4

SF score

-0.23**

0.21*

-0.22*

1

X5

VT score

-0.39**

0.29**

-0.43**

0.35**

1

X6

GH score

-0.38**

0.43**

-0.47**

0.24**

0.53**

X7

Age

0.13

-0.002

0.08

0.08

-0.002

-0.02

`1

X8

Sex

-0.15

0.10

-0.09

0.17

0.09

0.13

-0.11

* p < 0.05; ** p < 0.01

X8

1

1

Table 3. Summary of fit statistics in models 1, 2, 3, 4, and 5

Model

χ2

df

p

GFI

AGFI

TLI

CFI

RMSEA

R2

Model 1

4.4

5

0.49

0.99

0.96

1.01

1.00

Depression and pain impair daily functioning and quality of life in patients with major depressive disorder.

Depression and pain frequently occur together. The objective of this study was to investigate the effects of depression and pain on the impairment of ...
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