Effects Of Sleep Disturbance And Self-efficacy On Depressive Symptoms In Maintenance Hemodialysis Patients And Intervention Study

Objective:Chronic kidney disease(CKD)has become one of the major diseases threatening human life.A considerable proportion of CKD patients eventually develop into end stage renal disease(ESRD).At present,more and more ESRD patients need maintenance hemodialysis(MHD)to maintain their lives.Depressive symptoms and sleep disturbance are common but underestimated psychological and behavioral problems in MHD patients,and only a few patients receive appropriate treatment.Depressive symptoms,having a great impact on MHD patients,are associated with fatigue and cognitive dysfunction,influence the quality of life,and confer a higher risk of death and hospitalization.Sleep disturbance is an important influencing factor of depressive symptoms in MHD patients,which,however,is commonly ignored by most clinical staffs.As a kind of exploitable and measurable positive psychological resource,self-efficacy can improve the psychological and emotional disorders of MHD patients to a certain extent,and ultimately has important significance for improving their quality of life.Therefore,a comprehensive intervention program,which is constructed by focusing on the impact of sleep disturbance and self-efficacy and based on the eight-week positive psychotherapy course and the health education theory under the knowledge-attitude-practice model,has positive significance for the intervention of depressive symptoms on MHD patients.This study has been performed to clarify the influence of sleep disturbance,self-efficacy,demographic and clinical features on depressive symptoms of MHD patients,and to explore the moderating effect of self-efficacy between sleep disturbance and depressive symptoms through a cross-sectional investigation.Then,the Comprehensive Intervention Program for Depressive Symptoms in Maintenance Hemodialysis Patients has been constructed and modified using Delphi expert inquiry method,according to results of literature research and qualitative interview,and based on the eight-week positive psychotherapy course and the health education theory under the knowledge-attitude-practice model.Finally,a single-center,randomized controlled trial has been conducted to verify the clinical effect of the comprehensive intervention program.In overall,this study provided valid targets for the intervention of depressive symptoms,and reference for the application of a feasible comprehensive intervention program,which would strengthen the management of depressive symptoms and improve depressive symptoms in MHD patients.Methods:Part I:A cross-sectional survey method was conducted via convenient sampling in five hemodialysis centers in Beijing from June to October 2019.After obtaining the informed consent of MHD patients,the questionnaire was issued to collect the demographic indicators and disease-related indicators of patients.The patient health questionnaire(PHQ-9),Pittsburgh sleep quality index(PSQI)and general self-efficacy scale(GSES)were used to evaluate depressive symptoms,sleep disturbance and self-efficacy,respectively.Statistical analysis of the data was performed using the IBM SPSS 22.0 software and the PROCESS 4.1 plugin.The common method bias between baseline PHQ-9,PSQI and GSES were tested by Harman’s single factor test.Depressive symptoms were compared between patients with difference demographic and clinical features,using t-test or ANOVA for continuous variables andχ~2test or trendχ~2test for categorical variables.The correlations of PSQI and GSES with PHQ-9 were tested by Pearson correlation analysis.Multivariate hierarchical regression analysis was used to determine the influencing factors and the strength of depressive symptoms in MHD patients.The PROCESS procedure was applied to verify the moderating effect of self-efficacy in the relationship between sleep disturbance and depressive symptoms in MHD patients and to plot simple slope tests.P<0.05 was considered statistically significant.Part II:According to the quantitative research results in Part I of this study,the intervention target of depressive symptoms in MHD patients was determined.Based on the eight-week positive psychotherapy course and the health education theory under the knowledge-attitude-practice model,the Chinese and English databases were searched to extract the main structure and content of the intervention program.A semi-structured interview with MHD patients and related medical staffs was conducted.After analyzing the qualitative interview data and extracting the content of the intervention program,the Comprehensive Intervention Program for Depressive Symptoms in Maintenance Hemodialysis Patients(first draft)was constructed.Delphi expert inquiry method was adopted to systematically evaluate the intervention program.Statistical analysis of the data was performed using the WPS Office 2021,IBM SPSS 22.0 software.The effective recovery rate of the questionnaire was used to indicate the degree of enthusiasm of the experts,and greater than 70%indicated that the experts were highly motivated and the results were reliable.Expert authority coefficient(Cr)was determined by using expert familiarity(Cs)and expert judgment basis(Ca).A greater Cr value indicated a higher degree of expert authority,and Cr≥0.70 was generally considered acceptable.The average value and full score rate of importance indicated the concentration degree of expert opinions.A larger average value and higher full score rate indicated a higher degree of expert concentration.The Kendall’s W coordination coefficient was used to indicate the degree of expert coordination.A larger Kendall’s W coordination coefficient value indicated a higher degree of expert opinion coordination.P<0.05 indicated consistency among the experts.The comprehensive intervention program for depressive symptoms in MHD patients was further revised according to expert recommendations.MHD patients were selected for a preliminary experiment on the comprehensive intervention program,and the comprehensive intervention program was modified according to the results of the preliminary experiment to form the Comprehensive Intervention Program for Depressive Symptoms in Maintenance Hemodialysis Patients.Part III:A single-center,randomized controlled trial was conducted to verify the clinical effect of the Comprehensive Intervention Program for Depressive Symptoms in Maintenance Hemodialysis Patients.MHD patients meeting the inclusion and exclusion criteria were recruited in September 2021,and randomly assigned to the intervention group and the control group in a 1:1 ratio.For the intervention group patients,they were informed to sign informed consent and asked not to communicate with the control group patients about the intervention content.The doctor in charge of the blood purification center uniformly managed the patients involved in the intervention,and informed the patients in the intervention group to install Tencent Meeting on the mobile terminal and learn to operate.The older patients(over 60 years old)were assisted with installation and management by their families.Patients in the control group received routine treatment and nursing during blood purification treatment,and the patients in the intervention group implemented the eight-week comprehensive intervention program on the basis of routine treatment and nursing in the control group.The mobile phone-Tencent Meeting method was used to carry out the intervention program in the form of groups.Each group consisted of 8-10 patients.The starting point of the intervention was one week after the first enrollment.The intervention course was once per week for 50-60 minutes(the first 40 minutes were group discussions and the last 10-20 minutes were theory lectures).The intervention period of each group was 8 weeks.The scores of self-efficacy,sleep disturbance and depressive symptoms in the intervention group and the control group were measured by questionnaire(GSES,PSQI and PHQ-9)before and after the intervention for 8weeks,the third month after the intervention and the sixth month after the intervention.Statistical analysis of the data was performed using the IBM SPSS 22.0software.T-test,χ~2test or trendχ~2test were used to compare the baseline characteristics of the two groups.Paired t-test was used to compare the scores of each scale before and after the intervention in the intervention group.Fisher’s exact test was used to compare the remission rate of depressive symptoms between the two groups at different time points.The independent sample t-test was used to compare the scale scores of the two groups at different time points.Trends of variation and differences between the questionnaire scores of two groups were compared using repeated measures ANOVA.P<0.05 was considered statistically significant.Results:Part I:A total of 720 questionnaires were distributed and 667 valid questionnaires were completed,with a recovery rate of 92.6%.The average age of MHD patients was 59.34±13.54 years old.The average score of PHQ-9 was 5.54±4.01.The incidence of depressive symptoms was 53.37%.The results of univariate analysis showed that the level of depressive symptoms in MHD patients was related to gender,marital status,education level,family per capita monthly income status,renal origin disease,type of vascular access,regular special blood purification,complications/comorbidities,use of sedative hypnotic drugs and subjective self-care ability(P<0.05).The results of correlation analysis showed that sleep disturbance was significantly positively correlated with depressive symptoms(P<0.001),and self-efficacy was significantly negatively correlated with depressive symptoms(P<0.001).It showed that the more severe sleep disturbance indicated the more obvious depression symptoms,the higher degree of self-efficacy indicated the less depressive symptoms in MHD patients.The results of multiple stratified regression analysis showed that gender,complications/comorbidities and subjective self-care ability significantly affected depressive symptoms.Sleep disturbance had a significant positive effect on depressive symptoms(β=0.515,P<0.001),and self-efficacy had a significant negative effect on depressive symptoms(β=-0.338,P<0.001),with a total explanatory power of 56.4%.In addition,the interaction term of the product of sleep disturbance and self-efficacy was significant in the level of depressive symptoms(β=-0.086,P=0.001),indicating that self-efficacy played a negative regulation between sleep disturbance and depressive symptoms in MHD patients.Part II:Firstly,according to the quantitative research results in Part I of this study,the self-efficacy and sleep disturbance were identified as the targets of comprehensive intervention programs for depressive symptoms in patients with MHD.Secondly,a systematic search of Chinese and English literature was conducted on the positive psychotherapy and the health education theory under the knowledge-attitude-practice model before November 1,2020,and the retrieved literature was screened one by one,and finally 26 important documents were obtained.The research results of previous literature were analyzed and summarized,and the important items and key contents of"eight-week positive psychotherapy course"and"health education theory under the knowledge-attitude-practice model"were extracted,providing a theoretical basis for the main structure and content of the comprehensive intervention program for depressive symptoms in patients with MHD.Then,semi-structured interviews were conducted with 10 MHD patients and 6 healthcare providers engaged in the clinical treatment and care of blood purification.According to the qualitative interview results,the specific content of the intervention program was extracted,and combined with the previous quantitative research results and literature research results,the Comprehensive Intervention Program for Maintenance Hemodialysis Patients(draft)was constructed.Fourthly,the first draft of the intervention program was distributed through mail and other means.Using the Delphi expert letter inquiry method,18experts were selected to evaluate the pertinence and effectiveness of the intervention program content.During the distribution of the two rounds of expert inquiry questionnaires,the effective recovery rate was 100%.The expert authority coefficient was 0.87.After two rounds of expert correspondence,the averages of the comprehensive intervention items were 4.33-5.00.In the coordination test of expert opinions,Kendall’s W coordination coefficient was 0.298(χ~2=85.893,P<0.001).Finally,the problems occurred during the pre-experiment were revised and discussed again,and the final version of the Comprehensive Intervention Program for Depressive Symptoms in Maintenance Hemodialysis Patients was formed.Part III:There were 51 MHD patients each in the intervention group and the control group who completed the follow-up survey.The demographic and clinical baseline characteristics of the two groups were similar.At the baseline,there was no significant difference in self-efficacy,sleep disturbance and depressive symptoms.After the intervention,the GSES scores of the intervention group increased significantly,the PSQI and PHQ-9 scores decreased significantly(P<0.001).It indicated that self-efficacy of MHD patients improved,sleep disturbances decreased and depressive symptoms improved after comprehensive intervention.The remission rate of depressive symptoms after the intervention was 23.5%in the intervention group and 3.9%in the control group(P=0.008).At follow-up 3 month after completion of the intervention,the remission rate of depressive symptoms was 27.5%in the intervention group and 3.9%in the control group(P=0.002).At follow-up 6months after completion of the intervention,the remission rate of depressive symptoms was 33.3%in the intervention group and 7.8%in the control group(P=0.003).At the follow-up of 3 and 6 months after intervention,the GSES scores were significantly higher in the intervention group,and the PSQI and PHQ-9 scores were significantly lower than the control group(P<0.017).For self-efficacy,sleep disturbance and depressive symptoms,the interaction between intervention and time was statistically significant.The study variables not only showed significant differences between the intervention group and the control groups,but also showed statistically significant trends over time(P<0.001).Conclusion:The incidence of depressive symptoms in MHD patients was high,and sleep disturbance was positively correlated with depressive symptoms,while self-efficacy was negatively correlated with depressive symptoms.Self-efficacy played a regulatory role between sleep disturbance and depressive symptoms in MHD patients.Aiming at the above intervention targets of depressive symptoms in MHD patients,a comprehensive intervention program for depressive symptoms of MHD patients was constructed based on the eight-week positive psychotherapy course and the health education theory under the knowledge-attitude-practice model.The comprehensive intervention program can effectively enhance the self-efficacy of MHD patients,reduce their sleep disturbance,and finally improve their depressive symptoms.The positive effects of the comprehensive intervention program can last until 6 months after the completion of intervention.Participants are satisfied with the course of the comprehensive intervention program,and continue to provide positive feedback,further confirming the feasibility of the comprehensive intervention program that can be tried and promoted in clinical practice.