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A Comparison of the Efficacy of Health-Promoting Behaviors Intervention versus Well-Being Therapy on Psychological Distress in Infertile Women with Poly cystic Ovary Syndrome:

A Comparison of the Efficacy of Health-Promoting Behaviors Intervention versus Well-Being Therapy on Psychological Distress in Infertile Women with Poly cystic Ovary Syndrome: A randomized clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200122046228N8
Enrollment
100
Registered
2026-02-11
Start date
2026-04-03
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile women with polycystic ovary syndrome (PCOS). Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: Health-Promoting Behaviors Intervention: The health-promoting behaviors intervention will be delivered through counseling based on the 5A model over six sessions. T

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Infertile women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria and registered in the PCOS registry Presence of psychological distress, defined as a Global Severity Index (GSI) score between 0.5 and 2.0 Women of reproductive age (18–45 years) Access to the internet and a smartphone Ability to read and write Willingness to participate in the treatment and attend the intervention sessions, with informed consent provided.

Exclusion criteria

Exclusion criteria: Presence of severe psychiatric disorders (including severe depression, bipolar disorder, psychotic disorders, substance use disorders, or suicidal thoughts) as indicated by self-report elevated distress questionnaire scores

Design outcomes

Primary

MeasureTime frame
Psychological distress. Timepoint: Immediately after the completion of the intervention and three months later. Method of measurement: Brief Symptom Inventory-18 (BSI-18).

Secondary

MeasureTime frame
Psychological well-being. Timepoint: Immediately after the completion of the intervention and three months later. Method of measurement: Ryff’s Psychological Well-Being Scale (PWB).;Health-Promoting Behaviors. Timepoint: Immediately after the completion of the intervention and three months later. Method of measurement: Health Promoting Lifestyle Profile II (HPLP-II).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fatemeh Nasiri- Amiri

Babol University of Medical Sciences

nasiri_fa@yahoo.com+98 11 3219 0597

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026