Abstract
Objectives:
To explore the effects of combined intervention with education and progressive muscle relaxation (PMR) on quality of life (QoL), functional disability, and positive symptoms of patients with acute schizophrenia.
Methods:
This randomized controlled study took place in an acute schizophrenia ward in Changsha, China. Sixty-four patients with acute schizophrenia were randomly assigned to four groups: control, education, PMR, and education plus PMR. QoL was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form. Functional disability was assessed with the Sheehan Disability Scale. Severity of positive schizophrenia symptoms was assessed with the Scale for the Assessment of Positive Symptoms. All patients were evaluated at baseline (within 72 hours before the interventions) and at the end of weeks 5 (when the interventions ended) and week 15 (a 10-week follow-up after the interventions).
Results:
The sociodemographic and clinical characteristics of all four study groups were similar at baseline. Repeated-measures analysis of variance showed significant differences among the interventions in improving QoL, functional disability, and positive symptoms over time in the patients. Education and PMR alone resulted in sustained improvement of QoL during the intervention period and a 10-week follow-up but had no significant effects on functional disability or positive schizophrenia symptoms. In contrast, combined intervention with education and PMR showed better effects on improving QoL than did education or PMR alone throughout the 15-week study. It also statistically significantly improved functional disability and positive schizophrenia symptoms during the intervention period and led to sustained improvement of functional disability during the 10-week follow-up.
Conclusions:
A combined intervention with education and PMR is effective in improving QoL, functional disability, and positive symptoms in patients with acute schizophrenia. The combined intervention model could be a new paradigm of adjunctive treatment for acute schizophrenia.
Introduction
S
Schizophrenia is associated with impaired quality of life (QoL). 4,5 Psychosocial interventions, which frequently aim to improve patients' functioning and QoL, play an important role in treating patients with schizophrenia. 2 Structured patient education followed by discussion of the contents can improve the QoL of patients with schizophrenia. 6
Because traumatic and stressful events are common triggers of onset and exacerbation of psychotic symptoms, interventions that reduce anxiety and improve coping mechanisms are useful in managing the symptoms of schizophrenia. 3 Progressive muscle relaxation (PMR) is a systematic technique used to achieve a deep state of relaxation; it improves anxiety, depression, and health-related QoL in a variety of medical and psychiatric illnesses. 7 –9 PMR can alleviate anxiety in patients with schizophrenia. 10,11
The present study explored the effects of combined intervention with education and PMR on QoL, functional disability, and positive symptoms of patients with acute schizophrenia.
Materials and Methods
Patients
From August 2012 to September 2013, 60 patients with schizophrenia (34 men and 26 women, age 18–67 years) were recruited to this randomized controlled study from the acute psychiatric ward of Changsha Psychiatric Hospital, Changsha, China. The inclusion criteria were as follows: (1) diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, by two psychiatrists independently; (2) no history of substance abuse or organic brain disease; and (3) ability to read, write, and speak Chinese. Patients who previously received schizophrenia-related education and/or relaxation training were excluded from the study. A total of 117 patients who met the criteria were interviewed, of whom 64 agreed to participate in the study. The patients were randomly assigned to a control group, an education group, a PMR group, and an education plus PMR group by using block randomization with randomly selected block sizes of 4, 8, and 12 and an allocation ratio of 1:1. The Ethics Committee of the Third Xiangya Hospital, Central South University, approved the study. Patients or caretakers provided written informed consent before the start of the study.
Interventions
The entire study duration was 15 weeks. Interventions lasted 5 weeks, followed by a 10-week follow-up.
Education group
For the education group, patients attended one 30-minute group education session per week for 5 weeks, covering one topic each week in the following order: illness, treatment, well-being, support, and patients' rights. Each group education session was followed by a 15-minute group discussion of the contents taught. The average attendance rate for the group education sessions (±standard deviation) was 4.5±0.4 times per patient. The patients also received the following educational materials: (1) a brochure summarizing topics in the group education sessions and (2) a video CD containing a 30-minute video showing typical stories told by other patients with acute schizophrenia. In addition, the patients were provided a dedicated email address where they could send emails to the intervention staff for counseling.
PMR group
The PMR group received 5 weeks of PMR training, which followed previously standardized and validated procedures of Bernstein and Borkovec. 12 This technique involved systematically relaxing major muscle groups of the body with the goal of physical and mental relaxation. The PMR training provided for the PMR group included ten 30-minute group PMR practice sessions over 5 weeks, two sessions per week. The first session of PMR training included a general description of the purpose and rationale of relaxation and teaching the patients how to relax and contract 16 muscle groups. 12 From the second to the tenth group session, patients participated in group PMR practice preceded by a 15-minute group discussion of PMR experiences. The average attendance rate for the group PMR practice sessions was 8.3±0.6 times per patient. Patients also received a brochure describing the mechanisms and benefits of relaxation and a relaxation audio CD providing a guide for PMR practice. In addition, the patients were provided with a dedicated email address where they could communicate with the intervention staff about PMR experiences.
The patients were requested to perform self-practice of PMR at least once per day and record relaxation experiences in a specific form. They were also requested to bring their forms to the PMR group practice sessions. The form was reviewed immediately before each group session, allowing for discussion about problems encountered during self-practice of PMR. The patients practiced PMR 1.1±0.4 times per day on average during the 5-week intervention period. In the following 10-week follow-up period, the intervention staff encouraged the patients to continue self-practice of PMR at least once per day by sending email reminders two times per week. According to the patients' feedback, the patients practiced PMR 0.9±0.5 times per day on average during the 10-week follow-up period.
Education plus PMR group
In the education plus PMR group, patients received both education and PMR interventions. The group PMR practice sessions and the group education sessions were provided on separate days each week. The average attendance rate for the group PMR practice sessions was 8.8±0.7 times per patient. In the 10-week follow-up period, the intervention staff encouraged the patients to continue self-practice of PMR at least once per day by sending email reminders two times per week. All patients practiced PMR 1.2±0.3 times per day on average during the 5-week intervention period and 1.0±0.4 times per day on average during the 10-week follow-up period.
Control group
Patients in the control group received patient education according to usual ward procedures. In China, patient education varies between hospitals and units because there are no standardized and uniform guidelines in this area. Depending on individual nurses' own motivation and inclination, the patients may have received individual oral information on their illness and treatment in care meetings or in treatment groups. They may also have received written material or print-outs from the Internet. However, these educational activities were less systematic and varied widely. This group also participated in ten 30-minute sessions of mild group exercise over 5 weeks, two sessions per week. Each session was preceded by a 15-minute free group chat. The average attendance rate for the group exercise sessions was 8.5±0.8 times per patient. The interventions (Table 1) were delivered by the same set of trained intervention staff.
PMR, progressive muscle relaxation.
Instruments
All questionnaires originally developed in English were translated into Chinese and then back-translated to ensure accurate translation of the measures. QoL was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), a self-report instrument developed to assess the degree of enjoyment and satisfaction experienced by respondents. 13 The Q-LES-Q-SF, with 16 items, is identical to the General Activities subscale of the larger Q-LES-Q instrument. Each question is scored on a 5-point scale (1=very poor degree of enjoyment or satisfaction, 5=very good degree of enjoyment or satisfaction). The first 14 items are summed to produce a global QoL index with a maximum of 70 points. The last two questions concern medication and overall life satisfaction. 13 The Q-LES-Q has been used in clinical trials among patients with schizophrenia. 14,15 Earlier studies among patients with schizophrenia have reported moderate to high internal consistency of Q-LES-Q (Cronbach α=0.76–0.95) and good test-retest reliability. 16,17 In the present study, the Cronbach α for Q-LES-Q-SF was 0.87.
Functional disability was assessed with the Sheehan Disability Scale (SDS), which was developed to measure impairment in functioning of psychiatric patients in treatment outcome studies. The SDS is a self-report instrument assessing patient functioning using three items (work/study, social life, family life/home responsibilities). Each item is rated on a 10-point visual analogue scale (0=no disability, 1–3=mild, 4–6=moderate, 7–9=marked, and 10=extreme disability). SDS has been used previously in studies of patients with schizophrenia. 16 –18 The SDS has shown acceptable reliability (Cronbach α=0.56–0.86) given the small number of items. 18,19 In the present study, the Cronbach α for SDS was 0.82.
Severity of positive schizophrenia symptoms was assessed with the Scale for the Assessment of Positive Symptoms (SAPS). This semi-structured questionnaire assesses characteristics of hallucinations, delusions, bizarre behaviors, aggressive and anxious behaviors, and impaired active reasoning. Each question is evaluated at six levels, from “problem nonexistent” to “extremely severe.” The internal consistency of the SAPS scale is more than 0.80 in both English and Chinese versions. 11 In the present study, the Cronbach α for SAPS was 0.85.
Sample size and data collection
With two-sided α of 0.05, power of 0.80, and effect size of 1.2 (based on data from a pilot study in 24 patients with acute schizophrenia), a sample size of 12 was originally calculated for comparison of means between two groups. 20 After taking into account an anticipated 25% dropout rate, the investigators enrolled 16 patients into each group to ensure an adequate final sample size. At the end of study, 52 effective cases were collected (control group, n=13; education group, n=14; PMR group, n=12; education plus PMR group, n=13). Patients who attended fewer than four group education sessions or seven group PMR practice or group exercise sessions were considered dropouts. In the PMR and the education plus PMR groups, patients who did not do PMR self-practice on more than 14 days during the 5-week intervention period or the 10-week follow-up period were also considered dropouts. All patients were evaluated with Q-LES-Q-SF, SDS, and SAPS at baseline (within 72 hours before the interventions) and at the end of weeks 5 (when the interventions ended) and week 15 (a 10-week follow-up after the interventions).
Statistical analysis
Statistical analyses were performed with SPSS software for Windows, version 13.0 (IBM, Chicago, IL), by statisticians who were blinded to the study group assignment of the patients. For continuous variables, all values were expressed as the mean±standard deviation. The QoL, SDS, and SAPS scores were analyzed with repeated-measures analysis of variance (ANOVA). Within-group comparisons of the scores for Q-LES-Q-SF, SDS, and SAPS at different time points were done by using paired t tests. Comparisons of means among the study groups were performed with one-way ANOVA followed by post hoc pairwise comparisons using Tukey tests. Categorical variables were compared with chi-squared tests. A two-tailed p value <0.05 was considered to represent statistical significance in this study.
Results
As shown in Table 2, baseline sociodemographic characteristics, such as age, sex, living area (urban or rural), and education level, did not significantly differ among the study groups. There were also no significant differences in baseline clinical characteristics, including dose of antipsychotic drug (chlorpromazine equivalents), severity of positive symptoms (SAPS), and anxiety and depression (Table 3). The results indicate that all four study groups were similar at baseline.
For continuous variables, all values were expressed as mean±standard deviation; means were compared among multiple groups by using one-way analysis of variance. For categorical variables, all values were expressed as number (percentage); proportions were compared by using chi-squared tests.
All values were expressed as mean±standard deviation. Positive psychotic symptoms were evaluated with Scale for the Assessment of Positive Symptoms (SAPS).
Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS). The Cronbach's α was 0.85 for HADS-Anxiety and 0.89 for HADS-Depression in the present study.
Repeated-measures ANOVA were performed to evaluate the effect of time and intervention (control, education, PMR, and education plus PMR were treated as different levels of intervention) on QoL, functional disability, and positive symptoms of schizophrenia, respectively. The effect of interaction between time and intervention was also assessed. F values and corresponding p values for each test are listed in Table 4. The partial eta-squared values, which indicate the percentage of variance in QoL, functional disability, and severity of positive schizophrenia symptoms attributable to the effect of time, intervention, and interaction between time and intervention are also presented in Table 4. QoL, functional disability, and the severity of positive schizophrenia symptoms were assessed with Q-LES-Q-SF, SDS, and SAPS, respectively. As shown in Table 4, repeated-measures ANOVA revealed that time had a significant main effect on Q-LES-Q-SF, SDS, and SAPS scores. The intervention showed a significant main effect as well as interaction with time on Q-LES-Q-SF, SDS, and SAPS scores. This indicates significant differences among the interventions (control, education, PMR, and education plus PMR) in improving QoL, functional disability, and positive symptoms over time in the patients. The partial eta-squared value indicated that the interventions had the largest effect on QoL, followed by functional disability, and the severity of positive schizophrenia symptoms.
Quality of life, functional disability, and severity of positive schizophrenia symptoms were assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), Sheehan Disability Scale (SDS), and SAPS, respectively. The scores for Q-LES-Q-SF, SDS, and SAPS were analyzed with repeated-measures analysis of variance.
As shown in Table 5, compared with the baseline, all interventions statistically significantly improved the Q-LES-Q-SF score at week 5 (when the interventions ended) and week 15 (a 10-week follow-up after the interventions). Combined intervention with education and PMR also statistically significantly improved the SDS and SAPS scores at week 5. In contrast, education and PMR alone showed no significant effects on the scores for SDS and SAPS over time compared with the baseline. By the end of the 15-week study period, there were no statistically significant differences in the antipsychotic dosage of chlorpromazine equivalents among the intervention groups.
Quality of life, functional disability, and severity of positive schizophrenia symptoms were assessed with Q-LES-Q-SF, SDS, and SAPS, respectively. All values are expressed as mean±standard deviation. Within each group, paired t tests were performed to compare means between baseline and week 5 or week 15.
p<0.05 versus baseline.
Because the baseline scores of Q-LES-Q-SF, SDS, and SAPS differed among the study groups, changes in scores from the baseline were compared among the study groups at week 5 and 15. As shown in Table 6, all interventions statistically significantly improved the Q-LES-Q-SF score compared with the control group at week 5 and week 15. Combined intervention with education and PMR showed better effects on improving the Q-LES-Q-SF score than education and PMR alone throughout the 15-week study duration. The combined intervention also had statistically significantly better effects on improving the SDS score than all other groups at week 5 and than the control group at week 15. In addition, the combined intervention had statistically significantly better effects on improving the SAPS score than all other groups at week 5.
Quality of life, functional disability, and severity of positive schizophrenia symptoms were assessed with Q-LES-Q-SF, SDS, and SAPS, respectively. All values were expressed as mean±standard deviation. Means were compared among the study groups by using one-way analysis of variance followed by post hoc pairwise comparisons using Tukey tests.
p<0.05 versus control group.
p<0.05 versus education group.
p<0.05 versus PMR group.
Discussion
The present study appears to be the first to show the effectiveness of combined patient education and PMR on improving QoL, functional disability, and positive symptoms in patients with acute schizophrenia.
PMR is a primary method that can be easily learned to achieve relaxation. It is an effective intervention in reducing emotional distress. For example, practice of PMR has been proved to decrease or delay the onset of conditioned symptoms. 11 Regular practice of PMR can also enhance coping ability in a variety of stressful situations. 21 In addition, many empirical studies have found that PMR can enhance feelings of self-control. 11,22 PMR reduces anxiety in patients with chronic and acute schizophrenia. 10,11 The current study focused on exploring the effects of PMR on QoL, functional disability, and positive schizophrenia symptoms instead of repeating previous studies on anxiety. Nevertheless, the study groups did not significantly differ for anxiety or other clinical and sociodemographic characteristics at baseline. This indicates that the significant effects of PMR and education plus PMR observed in this study were not due to noncomparable levels of influencing factors (i.e., anxiety) among the groups at baseline. In addition, the group setting for the interventions was well controlled in the control group, which helped manifest the true effects of the interventions.
Patient education reportedly has a positive effect on schizophrenic patients' QoL, well-being, insight into their illness, and adherence to medication. 2 Various patient education interventions have been developed and proven effective in patients with schizophrenia. 2,6 Atkinson and colleagues reported that education significantly improved QoL and social functioning, but not mental state, in patients with schizophrenia. 23 In agreement with their report, the current study showed that education statistically significantly improved QoL but not the severity of positive symptoms in patients with schizophrenia. The current education intervention included five 30-minute group education sessions, one per week, with a 15-minute after-session group discussion of the contents taught. Like PMR, the education intervention was relatively easy to initiate and inexpensive to carry out, yet resulted in sustained improvement of QoL during the intervention and a 10-week follow-up. However, it showed no significant effects on social functioning, as reflected by the SDS functional disability scores. Nevertheless, combination of education with PMR led to statistically significant improvement in not only QoL throughout the 15-week study duration but also functional disability and positive schizophrenia symptoms during the intervention. The combined intervention also led to sustained improvement of functional disability during the 10-week follow-up.
Therefore, combined intervention with education and PMR could be used as a new paradigm of adjunctive treatment for acute schizophrenia. Although still significant compared with the baseline or the control group, the effect of the combined intervention decreased in the 10-week follow-up period after group education and group PMR practice were stopped at week 5. Thus, continuous group education and PMR practice is recommended to maintain the effect of the combined intervention. It would be important to find out the optimal frequency of group education and group PMR practice for long-lasting benefits in future studies.
This study had some limitations. First, only patients with acute schizophrenia were enrolled in this study because acute cases would more quickly show improvement in QoL, functional disability, and positive schizophrenia symptoms. Effects of combined education and PMR on patients with chronic schizophrenia will be explored in future studies. Second, the final follow-up was 10 weeks after the interventions. Long-term effects of the combined intervention with education and PMR would also be an interesting topic for future studies. Third, although the sample size was adequate for this study, a much larger study population will be needed to verify the clinical application value of the combined intervention model in future studies. Fourth, measures such as QoL and SDS do not necessarily work well across cultures. Thus, in future validation studies with a larger study population, the measures will first be restandardized.
In conclusion, this study demonstrates that combined intervention with education and PMR is effective in improving QoL, functional disability, and positive symptoms in patients with acute schizophrenia. Therefore, the combined intervention model could be a new paradigm of adjunctive treatment for acute schizophrenia.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
