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IRCT20260619069869N1 IRCT 2026-06-20 Babol University of Medical Sciences Two Approaches to Reducing Stress in Caregivers of Patients with Bipolar Disorder: Self-Compassion Therapy and Barcelona Psychoeducation " Comparing the effectiveness of self-compassion therapy and psychoeducation using the Barcelona method on the level of perceived stress in caregivers of bipolar patients" 2026-06-20 anticipated 36 Complete https://irct.ir/trial/91029 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Blinding is considered essential to maintain internal validity throughout a randomized controlled trial. However, given the nature of the intervention in this study, participant and interventionist blinding will not be feasible. Nevertheless, to minimize assessment and analysis bias, the statistician responsible for data analysis will be blinded to group allocation and type of intervention. Following randomization, self-compassion and perceived stress among caregivers will be assessed using the Neff Self-Compassion Scale (SCS) and the Brief Symptom Inventory-53 (BSI-53). These questionnaires will be completed by caregivers at three time points: baseline (pre-intervention), immediately after the completion of the intervention (post-test), and one month following the intervention (follow-up), for both study groups. Data collection will be performed using paper-based questionnaires when necessary and will be supervised by the principal investigator to ensure completeness and accuracy of responses. The intervention will consist of eight 45-minute sessions delivered over four weeks (two sessions per week) for participants in both groups. Training sessions will be conducted in a group format with approximately 10 participants per group. Sessions will be held at Yahya Nejad Hospital in a designated conference and training room. The intervention will be delivered by the responsible neurosurgery resident involved in the study implementation. The content of the educational program is based on the book “The Mindful Path to Self-Compassion” by Christopher Germer. The primary outcome of this study is the reduction in perceived stress among caregivers of patients with bipolar disorder, measured using the Perceived Stress Scale (PSS) immediately after the intervention and at one-month follow-up. N/A Bipolar Disorder (Bipolar I and Bipolar II disorder) and its associated caregiver burden, specifically perceived stress among family caregivers of patients with bipolar disorder.. Intervention group: Participants in the intervention group will receive a structured self-compassion training program based on the Mindful Self-Compassion approach by Christopher Germer and Kristin Neff. The intervention will consist of eight sessions, each lasting 45 minutes, delivered over four weeks (two sessions per week). Sessions will be conducted in a group format with approximately 10 participants per group.. Yes - There is a plan to make this available What will be shared: Demographic data of participants (such as age, gender, and caregiving status), after removal of any direct or indirect personal identifiers. Primary outcome data, including scores from the Neff Self-Compassion Scale and the Brief Symptom Inventory 53-item questionnaire, measured at three time points (baseline, post-intervention, and one-month follow-up). Anonymized participant codes to enable longitudinal tracking of data without the possibility of identifying individuals. When: Access to the anonymized study datasets and supporting documentation will begin 6 months after publication of the main study results in a peer-reviewed journal. The data will remain available for a period of 5 years from the start of the data sharing period, allowing qualified researchers to request access for secondary analyses during this timeframe. To whom: Academic researchers and faculty members affiliated with universities and recognized research institutions Independent researchers with a clearly defined academic affiliation Industry-based researchers, provided they have a clearly stated research purpose, approval from an appropriate ethics committee (if applicable), and a recognized institutional affiliation Conditions: Approved research purpose only: Data must be used exclusively for the objectives described in the approved research proposal. Any deviation requires prior written approval from the study team. Permitted types of analysis: Only statistical and epidemiological analyses consistent with the original informed consent and ethical approval are allowed. This includes descriptive analyses, inferential statistics, regression modeling, and secondary hypothesis testing related to psychological and behavioral outcomes. Machine learning or advanced data mining approaches are permitted only if explicitly stated in the approved proposal. No re-identification attempts: Any attempt to re-identify participants or link the dataset with external data sources is strictly prohibited. Where to obtain: Formal correspondence with the Principal Investigator (PI) Requests must be submitted in writing directly to the Principal Investigator. This is the primary and fastest route for review and processing of data access applications. Research Office or Ethics Committee Secretariat If access cannot be arranged through the Principal Investigator, or if legal/ethical review is required, requests should be submitted through the institutional Research Ethics Committee for further processing How to obtain: 1. Submission of Formal Request The applicant must submit a written request to the Principal Investigator including: Exact title of the proposed research Objectives of data use Planned statistical or analytical methods Ethics approval documentation (if available) ⏱ Estimated duration: 3–7 working days for initial registration and screening of the request 2. Initial Review by the Principal Investigator (PI) The PI evaluates the alignment of the request with the original study objectives, protocol, and ethical constraints. Clarifications or revisions may be requested from the applicant if necessary If approved, the request is forwarded to the next stage ⏱ Estimated duration: 1–2 weeks 3. Research Ethics Committee Review (if required) If the data are sensitive or secondary use of data is involved, the request is reviewed by the institutional ethics committee. Assessment of confidentiality safeguards and informed consent compliance Evaluation of proposed analyses ⏱ Estimated duration: 2–4 weeks (depending on committee meeting schedules) 4. Data Use Agreement (DUA) Execution After scientific and ethical approval, a formal Data Use Agreement is signed between the parties, specifying: Restrictions on data use Prohibition of participant re-identification Publication and dissemination conditions ⏱ Estimated duration: 3–7 working days 5. Data Preparation and Release The dataset is de-identified and prepared in a standardized format before being shared with the applicant. ⏱ Estimated duration: 1–2 weeks Comments:
public Mahfam Mojazi-Amiri
Babol, Modares Street, Shahid Mostafa Khomeini Street, Shahid Yahyanejad Hospital
Babol Iran (Islamic Republic of) 4713655647 +98 11 3222 3505 mmojazy@yahoo.com Babol University of Medical Sciences scientific Mahfam Mojazi-Amiri
Babol, Modares Street, Shahid Mostafa Khomeini Street, Shahid Yahyanejad Hospital
Babol Iran (Islamic Republic of) 4713655647 +98 11 3222 3505 mmojazy@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 55 years Ability to read and write. No history of major psychiatric disorders or current use of psychotropic medications, as assessed by the Brief Symptom Inventory-53 (BSI-53). Primary caregivers of patients with bipolar disorder who have experienced at least two mood episodes during the course of their illness or have been hospitalized more than once. Individuals who have been the patient's primary caregiver on a regular basis and are willing to participate in the educational sessions. 18 years 65 years Both F31.0 F31 – اختلال دوقطبی (Bipolar affective disorder)این کد شامل طیف اختلالات خلقی دوقطبی است که با دوره‌های مانیا، هیپومانیا، افسردگی و یا حالت‌های مختلط مشخص می‌شوند. Treatment - Drugs Intervention group: Participants in the intervention group will receive a structured self-compassion training program based on the Mindful Self-Compassion approach by Christopher Germer and Kristin Neff. The intervention will consist of eight sessions, each lasting 45 minutes, delivered over four weeks (two sessions per week). Sessions will be conducted in a group format with approximately 10 participants per group. Change in caregivers’ total perceived stress score, measured by the Perceived Stress Scale (PSS-14) at three time points: baseline, immediately after the intervention, and one-month follow-up.Change in caregivers’ total self-compassion score, measured by the Self-Compassion Scale (SCS) at three time points: baseline, immediately after the intervention, and one-month follow-up. Timepoint: Baseline (Pre-intervention): Prior to the initiation of the intervention program.Post-intervention: Immediately after completion of the 8-session intervention program (end of week 4).Follow-up: One month after completion of the intervention sessions. Method of measurement: The level of self-compassion among caregivers will be measured using the Neff Self-Compassion Scale, and perceived stress will be assessed using the Brief Symptom Inventory 53-item questionnaire (BSI-53).Both instruments are self-report questionnaires completed by the caregivers of patients. Babol University of Medical Sciences Approved 2026-06-16 Ethics committee of Babol University of Medical Sciences Yahyanejad Hospital, Mostafa Khomeini Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)