Page 223 - EJMO-9-2

Eurasian Journal of
Medicine and Oncology RCT of rTMS combined with HT for PSD

2.2. Sample size calculation integrates functional rehabilitation with psychological

Sample size was calculated based on the study by support and is personalized according to the degree of
Simning et al. The primary outcome variables were patients’ dysfunction and treatment stage; Group D:
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HAMD, HAMA, and SS-QOL scores. The sample size antidepressant medication combined with both rTMS and
was determined as 5 – 10 times the number of items in HT. Both interventions were applied as described above.
the scales, with an additional 10% to account for potential The HT program was designed based on the scale of
dropouts. To achieve 80% power at a 0.05 significance rehabilitation therapy hall. This intervention phase lasted
level, 18 participants were required per group. Considering 28 days, followed by a 6-month follow-up evaluation.
the 10% dropout rate, the final sample size was set at 20 2.5. Outcome measurements
participants per group, totaling 80 participants.
Clinical outcomes were assessed using HAMD, HAMA,
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2.3. Randomization and SS-QOL scales. Assessments were conducted at
baseline (pre-treatment) and on the 28 day of treatment
th
Eighty PSD patients were recruited and randomly assigned (post-treatment).
into four treatment groups using a computer-generated
randomization sequence (http://randomization.com) HAMD: Consists of 17 items, each scored from 0 to 2
with a block size of four. Group assignments were sealed or 0 to 4, with a total score ranging from 0 to 50. Higher
in numbered envelopes and disclosed to participants scores indicate more severe depressive symptoms. The
after baseline testing. To ensure allocation concealment, HAMD evaluates a range of depressive disorders, including
the envelopes remained sealed until the intervention those associated with physical illnesses, providing a
assignment and were opened by the study coordinator only comprehensive measure of depression severity.
after baseline assessments were completed. The allocation HAMA: Includes 14 items, each scored from 0 to 4, with
process to the intervention group was carried out by a total score ranging from 0 to 56. Higher scores indicate
social workers. Following group assignment, participants, greater anxiety severity. The HAMA comprehensively
occupational therapists, and outcome assessors remained assesses anxiety, including somatic symptoms.
blinded to group allocation. Data analysts, who were not
involved in the study design or clinical implementation, Stroke-Specific Quality-of-Life Scale: designed to
also remained blinded to group assignments. evaluate quality of life in stroke patients. Each item is
scored from 0 to 5, with higher scores indicating a greater
2.4. Intervention impact on quality of life. SS-QOL is used in clinical settings
All participants received daily antidepressant medication to assess the effectiveness of rehabilitation measures and
(escitalopram, 10 mg/day) and standard rehabilitation adjust treatment plans accordingly. Outcome assessments
treatment provided by the medical staff of the rehabilitation were conducted by an occupational therapist who was
department. The specific interventions for each group blinded to the intervention assignments.
were as follows (Figure 1): Group A (control group): 2.6. Statistical methods
Antidepressant medication only; Group B: Antidepressant
medication combined with rTMS. rTMS was administered Baseline characteristics for all four treatment groups
for 15 min/session, 5 days/week, targeting the left were analyzed using descriptive statistics and reported as
dorsolateral prefrontal cortex Stimulation parameters numbers, percentages, means, and standard deviations.
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included an intensity of 110% of the motor threshold and Mixed-effects restricted maximum likelihood regression
a frequency of 10 Hz; Group C: antidepressant medication was used to compare mean differences in HAMD, HAMA,
combined with HT. HT sessions lasted 45 min, 5 days/ and SS-QOL scores among the four treatment groups on
week. Activities were conducted in groups of 3 – 4 patients day 28 and during the 6-month follow-up. Assuming a
under the guidance of occupational therapists and social non-adherence and dropout rate of 20 – 30%, a sample
workers. Tasks were assigned based on the patient’s size of 20 participants per group was determined. A 95%
functional ability, ranging from fine motor activities (e.g., confidence interval that did not cross zero was considered
pruning plants) to auxiliary tasks (e.g., stabilizing tools or statistically significant.
providing assistance). The therapist adjusted the interactive 3. Results
mode in real-time according to the patient’s performance,
offering assistive devices or facilitating cooperation A total of 294 participants who met the inclusion
as needed. Social workers supervised the sessions and criteria were invited to participate in this community-
provided gardening knowledge to enhance participants’ based intervention study. Of these, 132 individuals
self-recognition of the intervention. This approach (44.9%) consented to take part in the trial. Eighty

Volume 9 Issue 2 (2025) 215 doi: 10.36922/EJMO025080032