Sleep-MOMagement: Improving Postpartum Sleep in First-time Mothers Through Tailored Behavioral Approaches.

Summary

The goal of this clinical trial is to find out if person-centered behavioral interventions can help first-time mothers sleep better after childbirth. The study compares two approaches-a behavioral sleep management program and a behavioral aerobic exercise program-to usual postpartum care for women experiencing insomnia symptoms.

The main clinical outcome is insomnia severity. The study also evaluates economic outcomes, including healthcare use, work absenteeism, overall health utility.

Participants will:

* Receive one of the interventions or continue with usual care.
* Keep a sleep diary, a diary on physical activity, and complete questionnaires about sleep, mood, daily functioning, psychosocial factors, and economic outcomes.
* Follow the program instructions, which may include sleep strategies or guided aerobic training, depending on the group.

Conditions

• Insomnia

Interventions

BEHAVIORAL

Behavioural Sleep Managament

The Behavioural Sleep Management intervention is provided by a master level physiotherapist and consists of sleep-focused psychoeducation, stimulus control, sleep hygiene, relaxation techniques, addressing unhelpful beliefs related to sleep , prioritizing self-care, checking for social support, and infant settling. The delivered form is based on CBT-I guidelines. Importantly, this intervention is not a form of psychotherapy. It does not involve exploration of emotional themes unrelated to sleep, diagnostic work, or cognitive restructuring beyond sleep-specific themes. Instead, it focuses on practical, educational, and behavioural strategies aimed at improving sleep quality and habits. Additionally, the intervention deliberately omits the time-in-bed restriction component typically found in standard CBT-I. This intervention is delivered through four appointments over a six-week period, supplemented with informational graphics and booklets that are sent via e-mail.

BEHAVIORAL

Behavioural Aerobic Exercise Therapy

The Behavioural Aerobic Exercise Therapy intervention is delivered by a master level physical therapist and primarily targets the daytime physical activity behaviour of the women. It includes coaching sessions focused on providing the necessary knowledge, skills, and support to implement an individually tailored aerobic exercise program and to adopt and sustain a physically active lifestyle. This intervention model aligns with the guidelines established by the American College of Sports Medicine. This intervention is delivered through four appointments over a six-week period, supplemented with informational graphics and booklets that are sent via e-mail.

Sponsors & Collaborators

• Vrije Universiteit Brussel

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• De deyne Manon

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2028-04-01

Completion

2028-11-01

Countries

• Belgium

Study Locations