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

NCT07345065 | Not Yet Recruiting

• 1 other identifier: FWOSB185
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

postpartum; sleep; insomnia; physiotherapy; behavioural; physical activity; women; circadian

Outcome Measures

Primary Outcomes (4)

• Insomnia Severity

  This outcome will be measured using the Insomnia Severity Index, a self-reporting questionnaire that evaluates the severity of insomnia symptoms over the past month through 7 items, each rated on a 0-4 scale. Higher total scores reflect greater insomnia severity.

  This outcome will be measured at the following endpoints: - T0 = Day 0 - T1 = Day 42 - T2 = Day 132 - T3 = Day 222 The primary endpoint is the difference between T0 and T3.

• Economic evaluations: Medical Consumption

  Medical Consumption Questionnaire (MCQ): A self-reporting generic (non-disease specific) questionnaire that identifies the direct costs of medical care, consisting of 29 questions.

  This outcome will be measured at the following endpoints: - T0 = Day 0 - T3 = Day 222

• Economic evaluations: Productivity Cost

  Productivity Cost Questionnaire (PCQ): A self-reporting questionnaire consisting of 3 aspects 1) absenteeism, 2) presenteeism, and 3) productivity losses associated with unpaid work.

  This outcome will be measured at the following endpoints: - T0 = Day 0 - T3 = Day 222

• Economic evaluations: Health-related quality of life

  EQ-5D-5L: A self-reporting questionnaire for measuring health-related quality of life, consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems).

  This outcome will be measured at the following endpoints: - T0 = Day 0 - T3 = Day 222

Secondary Outcomes (16)

• Sleep Quality

  This outcome will be measured at the following endpoints: T0 = Day 0 T1 = Day 42 T2 = Day 132 T3 = Day 222

• Sleep Propensity

  This outcome will be measured at the following endpoints: T0 = Day 0 T1 = Day 42 T2 = Day 132 T3 = Day 222

• Fatigue

  This outcome will be measured at the following endpoints: T0 = Day 0 T1 = Day 42 T2 = Day 132 T3 = Day 222

• Sleep-related beliefs and attitudes

  This outcome will be measured at the following endpoints: T0 = Day 0 T1 = Day 42 T2 = Day 132 T3 = Day 222

• Chronotype

  This outcome will be measured at the following endpoints: T0 = Day 0 T2 = Day 132 T3 = Day 222

Study Arms (3)

Treatment As Usual

NO INTERVENTION

The control group receives Treatment as Usual (TAU) based on standard postnatal care guidelines. As sleep management and physical activity are typically not part of these guidelines, this group serves as a 'waiting-list' control. After the study concludes, TAU participants are provided with BSM and BAET materials.

BSM (Experimental group 1)

EXPERIMENTAL

Behavioral: Behavioural Sleep Managament

BAET (Experimental Group 2)

EXPERIMENTAL

Behavioral: Behavioural Aerobic Exercise Therapy

Interventions

Behavioural Sleep Managament BEHAVIORAL

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.

BSM (Experimental group 1)

Behavioural Aerobic Exercise Therapy BEHAVIORAL

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.

BAET (Experimental Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women are eligible for study participation if they:
• (1) Have had a singleton pregnancy.
• (2) Are between 4 to 12 months postpartum with their first child.
• (3) Exhibit (sub)clinical insomnia, operationalized as an Insomnia Severity Index (ISI) score greater than 7 7 and having answered 'yes' on the following three statements: a) I have trouble falling asleep, and/or staying asleep and/or I have early morning awakenings AND this causes daytime symptoms. b) My sleeping problem is not caused by an external factor (the baby or my partner). c) These sleeping problems occur at least 3 times a week for at least 3 months.
• (4) Have access to a telephone, computer, and email.
• (5) Possess adequate Dutch literacy to comprehend therapy content, questionnaires, and instructions.

You may not qualify if:

• Women are excluded from participation if they:
• (1) Are currently pregnant.
• (2) Are shift workers.
• (3) Have severe diagnosed psychopathologies (e.g., bipolar disorder, post-traumatic stress disorder, psychosis)
• (4) Have current severe or untreated sleep disorders (narcolepsy, restless legs syndrome, circadian rhythm disorders)
• (5) Have an unstable medical condition that may disrupt sleep.
• (6) Have received cognitive-behavioural therapy for insomnia (CBTi) within the last 6 months.
• (7) Experience sleep deprivation due to unsettled infant sleep/wake behaviour, defined as the infant waking more than three times per night for more than 30 minutes and requiring parental support to re-initiate sleep.

Sponsors & Collaborators

• De deyne Manon: lead
• Vrije Universiteit Brussel: collaborator
• KU Leuven: collaborator

Study Sites (2)

Vrije Universiteit Brussel, Health Campus, Department of Physiotherapy

Brussels, Jette, 1090, Belgium

Location

KU Leuven, Departement of Physiotherapy

Leuven, Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Central Study Contacts

Manon De deyne, Master

CONTACT

+32498512698; manon.de.deyne@vub.be

liesbet De Baets, Professor

CONTACT

liesbet.debaets@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD researcher

Model Details: This study protocol outlines a parallel group (1:1:1) randomized controlled trial with an embedded qualitative component.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

BE (2)