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IRCT20260207068788N1 IRCT 2026-06-27 Babol University of Medical Sciences The effect of spiritual–psychological skills training on mental health and caregiving experiences of female caregivers of older adults Evaluation of the Effectiveness of Spiritual–Psychological Skills Training on Caregiving Burden, Mental Health, and Relationship Quality with the Elderly among Female Caregivers Sandwich Generation of Frail Older Adults (Randomized Controlled Trial) 2026-08-06 anticipated 116 Recruiting https://irct.ir/trial/89015 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals will be randomly allocated to the intervention and control groups using block randomization (with a block size of 4). The randomization list will be generated by a statistical collaborator using random allocation software and will be provided to the principal investigator. N/A Caregiver burden in female sandwich-generation caregivers of frail elderly. Intervention 1: Intervention group: Participants receive a spiritual-psychological skills training program over four weeks (eight 90-minute sessions, two sessions per week). The first four sessions are held in person at the Amirkola elderly cohort center and the next four sessions are held virtually via the Bale messaging app. Each session includes three parts: educational presentation (30 minutes), practical workshop (30 minutes), and group discussion with Q&A (30 minutes). Session content in order: (1) meaning of caregiving and spiritual well-being, (2) self-awareness and role conflict, (3) spirituality and resilience with breathing-contemplative exercises, (4) stress management with muscle relaxation techniques, (5) communication skills and active listening, (6) conflict management and support seeking, (7) self-care and burnout prevention, (8) summary and personal action plan. Audio and PDF files of session content are provided to participants. Absence from more than two sessions is an exit criterion. Intervention 2: Control group: Participants continue their usual caregiving for the older adult throughout the study (assistance with feeding, bathing, medication, treatment follow-up). This group receives no educational intervention. After study completion, all educational materials will be available for them free of charge. Yes - There is a plan to make this available What will be shared: All data can be published after being de-identified. When: 6 months after results are published. To whom: For the purpose of therapeutic practices and in accordance with all ethical principles. Conditions: For the purpose of therapeutic practices and in accordance with all ethical principles. Where to obtain: Corresponding author, Dr. Samaneh Pourhadi, via email at samaneh.pourhadi@gmail.com How to obtain: It must be clear who the request is from and for what purpose. The request is then reviewed by the research team and the university's vice president for research. If approved, the data will be sent. Comments:
public Marjan Niktalemi
Babol University of Medical Sciences, Ganjafrouz Street, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 4117647745 +98 13 3383 6393 mn.niktalemi74@gmail.com Babol University of Medical Sciences scientific Samaneh Pourhadi
Babol University of Medical Sciences, Ganjafrouz Street, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3219 0181 samaneh.pourhadi@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Women who provide in-home care for at least one frail older adult (with a minimum caregiving duration of three months). Concurrent membership in the sandwich generation (having at least one child under 18 years of age while also caring for an elderly parent). Age between 30 and 65 years. Living in Babol or Amirkola; Smartphone access Willingness and full informed consent to participate in the study. 30 years 65 years Female History of participating in similar spiritual-psychological skills training programs in the past six months. Simultaneous care of more than one frail older adult at home. Pregnancy or childbirth in the past three months. Having a plan to migrate from Babol city within the next four months. History of diagnosed severe psychiatric disorder. Behavior Behavior Intervention group: Participants receive a spiritual-psychological skills training program over four weeks (eight 90-minute sessions, two sessions per week). The first four sessions are held in person at the Amirkola elderly cohort center and the next four sessions are held virtually via the Bale messaging app. Each session includes three parts: educational presentation (30 minutes), practical workshop (30 minutes), and group discussion with Q&A (30 minutes). Session content in order: (1) meaning of caregiving and spiritual well-being, (2) self-awareness and role conflict, (3) spirituality and resilience with breathing-contemplative exercises, (4) stress management with muscle relaxation techniques, (5) communication skills and active listening, (6) conflict management and support seeking, (7) self-care and burnout prevention, (8) summary and personal action plan. Audio and PDF files of session content are provided to participants. Absence from more than two sessions is an exit criterion. Control group: Participants continue their usual caregiving for the older adult throughout the study (assistance with feeding, bathing, medication, treatment follow-up). This group receives no educational intervention. After study completion, all educational materials will be available for them free of charge. Caregiver burden score as measured by the Zarit Burden Interview (ZBI). Timepoint: Before intervention, immediately after intervention, and 3 months after intervention. Method of measurement: The Zarit Burden Interview (ZBI) questionnaire, consisting of 22 items on a 5-point Likert scale. Total score ranges from 0 to 88, which higher scores indicating greater caregiver burden. General mental health score. Timepoint: Baseline (before intervention), immediately after intervention (post-test), and 3 months after intervention (follow-up). Method of measurement: General Health Questionnaire (GHQ-12): A 12-item self-administered questionnaire for screening general psychological distress. Items are scored on a 4-point Likert scale (with total scores ranging from 0 to 12). Higher scores indicate poorer mental health status. Depression score. Timepoint: Baseline (before intervention), immediately after intervention, and 3 months after intervention. Method of measurement: Geriatric Depression Scale (GDS-15): A 15-item yes/no self-report scale designed specifically to assess depressive symptoms in older adults. Total scores range from 0 to 15, with higher scores indicating greater severity of depressive symptoms. Spiritual well-being score. Timepoint: Baseline (before intervention), immediately after intervention, and 3 months after intervention. Method of measurement: Spiritual Well-Being Scale (SWBS): A 20-item self-report scale measuring religious well-being (relationship with God), and existential well-being (sense of purpose and satisfaction in life). Items are rated on a 6-point Likert scale. Total scores range from 20 to 120, with higher scores indicating greater spiritual well-being. Relationship quality score. Timepoint: Before intervention, immediately after intervention, and 3 months after intervention. Method of measurement: Quality of Relationship Inventory (QRI): A 25-item inventory assessing three dimensions of relationship quality: support, conflict, and depth. Items are rated on a 5-point Likert scale. Total scores range from 25 to 125. Elderly daily functioning score. Timepoint: Before intervention, immediately after intervention, and 3 months after intervention. Method of measurement: Katz Index of Independence in Activities of Daily Living (ADL): A 6-item observer-rated scale assessing independence in six basic activities: bathing, dressing, toileting, transferring, continence, and feeding. Scores range from 0 (completely dependent) to 6 (completely independent). Babol University of Medical Sciences Approved 2026-02-02 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrouz Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)