The effect of progressive muscle relaxation therapy on diabetes distress & anxiety among people with type 2 diabetes

Materials & Methods

This prospective randomised intervention study was conducted by the department of Psychology, Prof. M Viswanathan Diabetes Research Centre, Chennai after obtaining the ethical approval by the Ethics Committee of the Institution. This randomised study screened 578 participants aged 25-60 yr with T2DM from MV Diabetes and Prof. M Viswanathan Diabetes Research Centre for diabetes in north Chennai, India, between July to August 2023 and were followed up till October 2023.

Study design

Out of 578 participants those with HbA1c >10 per cent (n=124), severe complications (n=56), and other serious illnesses (n=12) were excluded and the remaining 386 (209M:177F) participants were screened with Diabetes Distress Scale (DDS)¹⁵ and Generalized Anxiety Disorder (GAD) Scale¹⁶. The participants with DDS score of <3 and with a GAD score of Zero indicated that they did not have DD and Anxiety; hence, they were excluded. The remaining participants were enrolled into two study groups through computer-generated random numbers after screening (Figure). A written informed consent was obtained from all the participants after discussing the benefits and steps of PMR therapy.

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Figure.

The flowchart shows the screening and recruitment of the participants, and the procedure followed in the study. DDS, diabetes distress Scale; GAD, generalized anxiety disorder Scale.

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Results

Table I summarises the baseline characteristics of the study groups. The mean age was similar in both the groups. Sixty-four per cent of the participants in the control and 47 per cent of them in the intervention group completed school-level education. The duration of diabetes was similar in the study groups. Both the study groups were matched for their age and duration of diabetes. The mean age was 50.9 yr in group 1 and 50.1 yr in group 2, respectively. The mean duration of diabetes was 6.7 yr in group 1 and 6.9 yr in group 2. Most of the participants in both groups were from middle-class economic status, followed by upper-middle-class, and very few respondents were from lower socioeconomic status. Fifty-three per cent from the control and 44 per cent of participants from the intervention group reported walking as a form of physical exercise and following dietary advice. About a third (30.6%) of group 1 participants were on sulphonylureas, 25 per cent used biguanides, and 44.4 per cent used a combination of both, while 33.3 per cent were on sulphonylureas, 16.7 per cent used biguanides and 50 per cent used both in group 2. Nearly 70 per cent participants in the intervention group practiced the PMR therapy regularly and the remaining practiced twice or thrice in a week.

Smoking and alcohol consumption were similar in both groups. The presence of hypertension was significantly higher in group 1 (28%) than in group 2 (8%; P=0.032). Eleven per cent of participants in group 1 and 17 per cent of participants in group 2 were confirmed to have dyslipidemia. Nineteen per cent in both groups had the presence of both hypertension and dyslipidemia.

Table II compares the anthropometric, hemodynamic, and biochemical details of the study groups at baseline and follow up. In both groups, no significant reduction was noted in BMI and systolic blood pressure. No change was noted in diastolic blood pressure in group 1, whereas a significant reduction was noted in group 2 (P=0.001) at follow up.

Both the groups were matched for HbA1c at baseline. The group who received the PMR therapy showed a statistically significant reduction in HbA1c percentage (baseline vs. follow up; 9.2 vs. 7.6), fasting (194.5 vs. 142.4) and PP glucose levels in mg/dl (266.5 vs.175.5; P=0.001).The control group showed an increase in HbA1c, fasting and PP glucose levels. The impact of PMR therapy was also reflected in the lipid profile of the group 2 participants, which showed a significant reduction in lipid parameters like triglycerides, total and LDL cholesterol. HDL cholesterol increased significantly in group 2 (P=0.005). Lipid profile did not show any significant difference in control group except for HDL cholesterol which decreased significantly (P=0.009).

Table III shows the mean item scores of the DDS and GAD-7 within the study groups. The scores of four subscales of DDS: emotional, physician-related, regimen-related, and interpersonal distress were significantly decreased at follow up in group 2 participants as compared to baseline and a significant decrease was also noted in the total score of DDS (3.8 vs. 1.6) and GAD Scale (17.9 vs. 6.3) (P<0.0001) among the participants who followed the PMR therapy. In group 1 participants, the emotional, interpersonal and regimen-related distress scores showed a minimal increase in the follow up mean scores, whereas physician-related distress showed a minimal decrease among the participants. The total scores of DDS (3.9 vs. 4.4; P=0.001) and GAD Scale (17.4 vs. 18.6; P=0.015) showed a significant increase in group 1 participants.

Table IV compares the mean difference of DDS and GAD-7 scores between the baseline and follow up visit in emotional burden, physician-related, regimen-related, interpersonal distress. Total DDS score was significantly different in group 2 when compared to group 1.The mean difference score of GAD between the groups was also statistically significant, with a greater reduction in group 2 (P=0.001). Overall, there was a greater reduction in the total DD score and anxiety disorder score in the participants of the PMR therapy group. Seventy per cent participants in group 2 followed PMR therapy everyday and the remaining 30 per cent followed six days per week. Out of the 40 participants all joined the weekly therapy sessions for 10 wk, two were absent for the 11th wk and three were absent for the 12th wk but they continued their regular therapy practice.

Discussion

People living with diabetes are more likely to experience stress because of the anguish of their disease. This condition leads to DD and anxiety. This study helped to determine the effectiveness of PMR therapy on DD and anxiety among people with T2DM. Numerous measurements such as anthropometric, lipid, hemodynamic parameters and glycemic control were used to evaluate the effectiveness of the therapy. This study also examined the impact of PMR therapy along with medications on the above parameters and demonstrated an encouraging impact on a number of outcome indicators. The findings illustrated that consistent practice of PMR therapy combined with conventional medication showed a significant improvement in glycemic control, and reduction in lipid and hemodynamic parameters. There was a greater reduction noted in the total DD and anxiety scores among those who followed the PMR therapy. Similar educational backgrounds and having identical socioeconomic status, BMI, age, glycemic status, and duration of diabetes between the study groups prevented confounding effect on intervention outcomes. Using a successful follow up strategy of sending daily messages through WhatsApp groups and making phone calls, our study yielded a response rate of 90 per cent. In our study, the impact of PMR therapy was most apparent in relation to glycemic status and the decrease in diabetes distress and anxiety scores. More than 70 per cent of the participants in the intervention group practised PMR therapy regularly to achieve favourable outcomes.

Our findings were consistent and similar to the previous reports from other populations^18,19. A very recent study from Indonesia showed that PMR reduced stress and glucose levels in people with T2DM. The authors suggested that Jacobson’s PMR approach could help individuals with diabetes reduce stress, anxiety, and depression while also promoting sustainable stress prevention strategies¹⁹. PMR can also reduce sadness, anxiety, stress, and glucose levels and improve quality of life. The study done in Egypt showed a remarkable difference in DD and anxiety among the study participants²⁰. Also, PMR technique was found to be effective in reducing depression in people with diabetes²¹, supporting the evidence generated from our study. PMR may reduce anxiety and depression by regulating the central and peripheral nervous systems, potentially blocking physiological and psychological responses to anxiety.

Our study findings showed promising results on the effect of PMR therapy in reducing glucose levels, HbA1c and lipid parameters. Similarly, in another study, the PMR technique and a structured exercise programme were effective in reducing HbA1c in individuals with T2DM. The study conducted in Indonesia also proved the effectiveness of progressive relaxation in reducing glucose levels¹⁸. Another study in older people, suggested that the use of evidence-based complementary therapies in general health care services may enhance quality care and promote positive health care service delivery²². Our study findings contrast with the research conducted in Iran, which indicated that PMR had no impact on glycemic control and quality of life in individuals with T2DM²³.

The effectiveness of PMR therapy was evident from the above studies. In one of our previous reports, it was proved that women had high levels of distress in managing diabetes as compared to men⁴. This study used the same DDS-17 item Scale to assess DD. It was reported that 55 per cent of women had moderate to high diabetes related distress on DDS-17 Scale⁴. Women may be targeted and guided to practice PMR in order to reduce DD and anxiety. Another study conducted on Indian population reported the prevalence of DD as 42 per cent and it was significantly and negatively associated with the domains of self-management such as dietary control, glucose management and health care use²⁴. One of the recent studies from eastern India also showed a high prevalence of DD in 77 per cent participants and emotional distress was more common²⁵.

In our study, there were no adverse events reported and few participants from the intervention group participated enthusiastically in the therapy session and mentioned that they experienced a calm and peaceful attitude. This anti-stress benefit of PMR therapy may contribute to greater control over their glucose levels. The limitations of the study were as follows: the sample size was small and the findings of this study have to be confirmed by further evaluating the effect of PMR therapy in a larger sample. It is also necessary to assess the long-term sustainability of PMR therapy’s effect on glycemic control, DD and anxiety. The study was conducted in a single centre, thus restricting the generalizability of the findings.

Overall, the findings in this study suggested that PMR therapy had a positive effect on diabetes distress and anxiety among people with T2DM. The study indicates that PMR can enhance their glycemic control. Therefore, regular use of PMR therapy in conjunction with conventional medications may be advantageous for better diabetes management and improve the quality of life of people with T2DM. This can be implemented by reinforcing the practice of PMR therapy for all people with T2DM at every follow up visit.