1. Patients and design
This randomized control trial was performed at our dialysis center in the First Navy Hospital of Southern Theater Command. Participants were recruited between January 1, 2021, and December 31, 2022. Figure 1 showed the participant flow chart; 182 patients were approached to the study, qualified by two senior nephrologists. Inclusion criteria included: consent to participate in the trial, maintenance HD in our center for no less than 6 months (frequency three times weekly), age 18 to 78 years. Exclusion criteria included: current hospitalization, acute cardiovascular events in the last three months, cerebrovascular events, uncontrolled severe hypertension, poorly controlled diabetes, malignant tumors, other mental or neurological diseases, and surgical operations performed in the last month. After exclusion of 113 HD patients, a total of 69 participants satisfying the criteria were randomly assigned. The study was approved by the First Navy Hospital of Southern Theater Command’s ethics committee.
2. Randomization
Patients were recruited in the dialysis unit and required an assessment to determine eligibility for the clinical trial. When a cohort of 10–12 participants was accrued, participants of that cohort were randomly assigned by an independent research assistant, on a 1.3:1 basis, by a computer-generated random number list, to the study group or control group. Then, the study group was scheduled to receive supportive psychotherapy, a control group to continue usual treatment. Assistants were blinded to the baseline assessments of participants.
3. Procedures
3.1. Therapies Supportive psychotherapy was chosen as an interventional tool for the following reasons. On the one hand, we believed that psychotherapy would be the more appropriate invention choice than pharmacotherapy in patients with mental disorders. On the other hand, supportive psychotherapy was specifically utilized, and the manual’s goal is to strengthen coping skills, reduce social isolation, decrease anxiety, enhance self-esteem, and facilitate reality testing and problem solving [9]. The study group began the intervention within one week after completion of the assessment. The full protocol included 30 minutes a session per week offered over the 3-month study. At baseline, all the participants were initially assessed. After 3-month follow up, the study group completed the intervention and both groups were reassessed.
3.2. Therapists
The therapies were provided by altogether three therapists who received standard training in supportive psychotherapy. Therapists had obtained professional qualifications in solution-focused therapy. The average years of experience for therapists in psychotherapy was more than 10 years.
4. Assessment
4.1. Measurement
All assessments were performed by an independent assessor who was blind to the participant’s baseline information and treatment condition. Generalized Anxiety Disorder 7-item (GAD-7), Pittsburgh Sleep Quality Index (PSQI), and Morisky Medication Adherence Scale 8-item (MMAS-8) were measured at baseline and 3 months.
GAD-7
The GAD-7 questionnaire is a self-administered instrument for assessing anxiety disorders. The GAD-7 consists of seven items that describe the most important diagnostic criteria for GAD, namely Criterion A (fear and anxiety associated with a series of events or activities), Criterion B (difficulties in controlling concerns), and Criterion C (anxiety and worry are based on at least three additional symptoms, including restlessness, difficulty concentrating, mild fatigue, muscle tension, irritability, and sleep problems). According to the GAD-7 scale, people were asked how often they have experienced the seven core symptoms within the last two weeks with the response choices being ‘never’, ‘on some days’, ‘on more than half of the days’ and ‘almost every day’ (scored 0–3, with a total score ranging from 0 to 21). A score > 4 indicates clinically elevated anxiety [10].
PSQI
The PSQI scale is extensively utilized and is a reliable indicator that reflects global sleep status in different individuals and populations with sleep or mental disorders over the past month. In accordance with the severity of various sleep disorders, the 19 items are divided into seven component scores: subjective sleep quality, sleep latency, sleep duration, sleep disturbance, habitual sleep efficiency, use of sleep medication, and daytime dysfunction. After weighting the seven components on a scale ranging from 0 to 3, the PSQI score, ranging from 0 to 21, can be calculated. Increasing sleep scores for each component or the global PSQI score indicate poor sleep quality [11].
MMAS-8
Currently, MMAS-8 is widely used as a tool for measuring medication adherence in survey research, and its concurrent validity with non-humanistic measures of adherence has been demonstrated. Several questions are designed to avoid ‘yes-saying’ bias (item 5 is reworded to prevent responding in the same way to different questions regardless of their content). Items 1 through 7 have a ‘yes’ or ‘no’ response choice, while item 8 has a five-point Likert response choice. A 'no' response is rated as 1 and a 'yes' response is rated as 0, except for item 5, in which a 'yes' response is given a 1 and a 'no' response is given a 0. For item 8, a summated score is calculated by dividing the result (0–4) by 4. A total score of 8 on the MMAS-8 indicates high adherence, a score of 7 or 6 indicates medium adherence, and a score of 6 indicates low adherence. Specially, this measure was designed to facilitate the recognition of barriers to and behaviors associated with adherence to chronic medications [12].
4.2. Baseline variables
Demographic factors (age, gender, marital status, living status, education, medical insurance, and family income), and medical information (primary cause, dialysis duration, history of kidney transplant, vascular access, and laboratory values), and other treatment parameters were determined at baseline by interviews and questionnaires.
4.3. Outcomes variables
The primary outcome was the changeover in the time of anxiety severity during the past 3 months with GAD-7 scores. Secondary outcomes included 2 subscales; sleep quality score and the number of sleep disorders during the past 3 months, assessed with the PSQI; medication adherence score and the number of medication nonadherences, assessed with the MMAS-8.
5. Statistical analysis
An analysis of descriptive statistics, medians, means, percentages, and standard deviations for the group was performed. The S-W test and K-S test were utilized to examine the normality of the distribution of the examined variables. The independent sample t-test was used to compare the data between the two groups, and the chi-square test was conducted to compare the count data in terms of composition ratio (%). Pearson’s correlation or Spearman’s rank correlation or coefficient were performed to estimate selected variables. Statistical analysis was performed by using the SPSS version 26. A p value less than 0.05 was regarded as statistically significant.