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Designing an iCBT intervention for menopausal symptoms

Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for menopausal symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201226049833N2
Enrollment
150
Registered
2024-08-21
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Women aged 40 to 60, undergoing menopause or post-menopause, according to the definition of STRAW+10, who have hot flashes and night sweats..

Interventions

Intervention 1: Intervention group: Intervention group: Women in the therapist-supported iCBT group have access to a 6-module program for 6 weeks. Each week before the program begins, a video call ses

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women aged 40 to 60, undergoing menopause or post-menopause, according to the definition of STRAW+10, (b) having access to the Internet, (c) having access to a telephone, mobile phone. (d) have sufficient knowledge of Farsi language. (e) at the time of entering the study suffering from a specific disease or serious cognitive or psychiatric problems that are not able to follow the intervention or complete the study questionnaires (f) during the last three months He has not used treatments such as hormone therapy, food supplements, herbal medicines.

Exclusion criteria

Exclusion criteria: (1) Failure to complete the consent form (2) serious cognitive or psychiatric problems (such as depression, alcohol dependence, or psychotic disorders) as determined by a psychiatric interview; (3) treatment for another type of cancer. (4) the presence of severe relationship problems for which an Internet-based program is not suitable; (5) Participation in a concurrent treatment program to reduce menopausal symptoms. (6) participation in a concurrent CBT program for other psychological problems;

Design outcomes

Primary

MeasureTime frame
Severity of menopause symptoms. Timepoint: At the beginning of the study (before the start of the intervention), 6 and 26 weeks after randomization. Method of measurement: Green scale.;MENQOL quality of life index for postmenopausal women. Timepoint: At the beginning of the study (before the start of the intervention), 6 and 26 weeks after randomization. Method of measurement: Menqol questionnaire with 29 questions.

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI). Timepoint: At baseline and 6 and 26 weeks after randomization. Method of measurement: The Pittsburgh Sleep Quality Questionnaire (PSQI) has 19 questions.;Perceived quality index of marital relationship dimensions PRQC. Timepoint: At baseline and 6 and 26 weeks after randomization. Method of measurement: 38-question questionnaire of perceived quality of marital relationship dimensions.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactnajmeh pourshahrokhi

Kerman University of Medical Sciences

n.pourshahrokhi95@gmail.com+98 34 4331 5084

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026