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IRCT20261013071422N1 IRCT 2026-11-02 Zanjan University of Medical Sciences Investigating the effect of using the Newman's systems model on the level of stress and the needs of depressed patients Investigating the effect of using the Newman's systems model on the level of stress and the needs of depressed patients 2026-11-22 anticipated 80 Pending https://irct.ir/trial/94117 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Considering the study conditions and the need for rapid and practical access to the target population, convenience sampling was employed. In this method, individuals who met the inclusion criteria and were accessible to the researcher were selected. Accordingly, after identifying eligible participants, they were randomly allocated to the intervention and control groups using a block randomization technique, taking into account individual characteristics (gender, age, marital status, and educational level) to reduce bias and ensure balance between the groups. To implement random allocation, standard procedures were used, including sealed, coded envelopes and a pre-generated randomization list. Each allocation was placed in an opaque, numbered envelope. The researcher, without knowledge of the envelope's contents, opened the envelopes sequentially according to their numbers and assigned each participant to the designated group. Furthermore, the following formula was used to estimate the sample size as an alternative to Cochran's formula, which is commonly applied to small and finite populations: In this formula, $N$ represents the sample size for an effectively infinite population, which is generally assumed to be 384; $t$ is the coefficient corresponding to the selected confidence level; $S$ represents the estimated existing or preliminary variance; and $d$ denotes the acceptable margin of error. In statistical and research methodology references, this formula is commonly referred to as a modified sample size formula or a formula suitable for small samples. It is also known by other terms, such as the “sample size formula based on population variance for a finite sample” or the “sample size formula for a finite population.” Based on this formula, with a 95% confidence level, a 5% margin of error, a statistical power of 80%, and a variance of 1.96, the calculated sample size for a population of 384 was 80 participants, Blinding description: Given the nature of the intervention and the way the research program was implemented, complete blinding of participants and researchers was not feasible. However, to reduce bias in the analysis of the results, blinding was implemented at the level of the statistical analyst. Specifically, data related to participants were provided to the analyst using anonymous codes, without identifying group allocation (intervention or control). Therefore, the statistical analyst was unaware of participants’ group assignments, and data analysis was performed without knowledge of the type of intervention received. This approach helps reduce observer bias during the data analysis phase. N/A Depressive Disorder. Intervention 1: Intervention Group: Participants in this group received nursing care based on the Neuman Systems Model over a four-week period, consisting of four 45-minute sessions. The intervention was delivered by a trained researcher and was designed according to the three levels of prevention: primary, secondary, and tertiary prevention.Sessions 1 and 2 aimed to reduce stressors, strengthen patients’ lines of defense, and increase awareness of depression and stress management. The content included education about depression and stressors, progressive muscle relaxation, diaphragmatic breathing, basic mindfulness, healthy nutrition principles, and daily activity planning.Session 3 aimed to manage symptoms and reduce stress responses. It included training in adaptive coping skills, guided mindfulness exercises, introductory cognitive restructuring, identification of stress triggers, and development of an individualized stress-reduction plan.Session 4 aimed to prevent relapse and maintain behavioral changes. It included developing an individualized relapse-prevention plan in collaboration with the patient, reviewing the skills learned, teaching patients to recognize early warning signs, and planning timely actions when symptoms emerge.Participants’ perceived stress and basic needs were assessed using the corresponding questionnaires at baseline, before the intervention, and at the end of Week 4, after completion of the intervention. Intervention 2: Control Group: Participants in this group received usual care, including general education and visits with a psychiatrist. During the four-week study period, no structured nursing intervention based on the Neuman Systems Model was provided to this group. The Perceived Stress Scale and the Basic Needs Questionnaire were completed at baseline and at the end of Week 4. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Masume Asgari
No.20, 6th Parand Alley, Parand st, Abhar Road
Gheydar Iran (Islamic Republic of) 4581987848 +98 24 3421 6223 m.asgari1378@yahoo.com Zanjan University of Medical Sciences scientific Dr Korosh Amini
School of Nursing and Midwifery, Zanjan University of Medical Sciences Campus, Dr. Yousef Sobouti Boulevard, Zanjan.
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3315 6263 korosh_amini@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Clinical diagnosis of depression according to the DSM-5 or ICD-10 criteria, without distinguishing between different types of depression Age between 18 and 65 years Clinical stability, defined as no psychiatric hospitalization and maintenance of social functioning, and no use of psychiatric medications during the three months preceding the start of the study Provision of informed consent and explicit agreement to participate in the study Absence of other psychiatric disorders in the participants. 18 years 65 years Both The patient is unwilling to continue participating in the study for any reason The patient experiences serious psychological or physical adverse effects. The patient does not adhere to the study recommendations and protocol. The occurrence of emergencies or death that make continued participation in the study impossible. F33.0 Major depressive disorder, recurrent, mild Rehabilitation N/A Intervention Group: Participants in this group received nursing care based on the Neuman Systems Model over a four-week period, consisting of four 45-minute sessions. The intervention was delivered by a trained researcher and was designed according to the three levels of prevention: primary, secondary, and tertiary prevention.Sessions 1 and 2 aimed to reduce stressors, strengthen patients’ lines of defense, and increase awareness of depression and stress management. The content included education about depression and stressors, progressive muscle relaxation, diaphragmatic breathing, basic mindfulness, healthy nutrition principles, and daily activity planning.Session 3 aimed to manage symptoms and reduce stress responses. It included training in adaptive coping skills, guided mindfulness exercises, introductory cognitive restructuring, identification of stress triggers, and development of an individualized stress-reduction plan.Session 4 aimed to prevent relapse and maintain behavioral changes. It included developing an individualized relapse-prevention plan in collaboration with the patient, reviewing the skills learned, teaching patients to recognize early warning signs, and planning timely actions when symptoms emerge.Participants’ perceived stress and basic needs were assessed using the corresponding questionnaires at baseline, before the intervention, and at the end of Week 4, after completion of the intervention. Control Group: Participants in this group received usual care, including general education and visits with a psychiatrist. During the four-week study period, no structured nursing intervention based on the Neuman Systems Model was provided to this group. The Perceived Stress Scale and the Basic Needs Questionnaire were completed at baseline and at the end of Week 4. Perceived Stress ScoreChange in the total perceived stress score among patients with depression, measured using the 10-item Perceived Stress Scale (PSS-10), from baseline to post-intervention following four weeks of nursing care based on Neuman Systems Model. Timepoint: At baseline, before the intervention (pre-test), and at the end of Week 4, after completion of the intervention (post-test). Method of measurement: The ten-item Perceived Stress Scale, consisting of ten questions rated on a five-point Likert scale, with a total score ranging from zero to forty, used to assess patients’ perceived stress over the previous month. Basic Needs ScoreChange in the basic needs score among patients with depression, measured using the Asgharipour Basic Needs Questionnaire based on Maslow’s hierarchy of needs, from baseline to post-intervention following four weeks of nursing care based on Neuman Systems Model. Timepoint: At baseline, before the intervention (pre-test), and at the end of Week 4, after completion of the intervention (post-test). Method of measurement: The Maslow Basic Needs Questionnaire developed by Asgharipour, consisting of sixty-four dichotomous yes-or-no questions, used to assess five dimensions of basic needs: physiological needs, safety needs, belongingness needs, esteem needs, and self-actualization needs. Zanjan University of Medical Sciences Approved 2026-08-31 Zanjan University of Medical Sciences Ethics Committee Professor Sobouti Boulevard Zanjan Zanjan Iran (Islamic Republic of)