Does a program-based cognitive behavioral therapy affect insomnia and depression in menopausal women? A randomized controlled trial

Background: Menopausal women often complain of a range of physical and psychological symptoms known as menopausal syndrome. These symptoms are associated with fluctuating hormone levels, sleep disturbances, and mood swings. Aim: This study aimed to examine the efficacy of a program-based cognitive behavioral group therapy (CBT) for insomnia and depression among women experiencing menopause. Methods: A randomized controlled trial of 88 women experiencing menopause was conducted in Egypt from June to September 2022 in outpatient clinics at Mansoura University Hospitals in Egypt. Participants were randomly assigned to a control group (45 women) and an intervention group (43 women). The intervention group received 7 weeks of CBT sessions. Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Inventory 2nd Edition (BDI-II) were administered before and after the intervention. Results: In the intervention group, there was a significant difference in scores of the subdomains of PSQI, including sleep efficiency, daytime dysfunction, subjective sleep quality, and sleep disturbance (t = 8.911, 11.77, 7.638, and 11.054, respectively), while no significant difference in domains of using sleep medication, sleep duration, and sleep latency. Significant improvements were observed between pre-and-post-intervention in the intervention group for the total scores of PSQI, ISI, and BDII-II (t = 12.711, 16.272, and 12.384, respectively), indicating a large effect size for the three studied variables (r =.81,.87,.8, respectively). Linking Evidence to Action: This study demonstrated the efficacy of group CBT for lowering insomnia and depression in women experiencing menopause. Thus, results indicated the need of considering prompt and appropriate interventions such as CBT as a safe treatment option to prevent the aggravation of sleep and emotional problems for menopausal women. Trial Registration: ClinicalTrials.gov Identifier: NCT05920460.