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Randomized controlled study of internet-based cognitive behavioural therapy for women having post-traumatic stress after childbirth

A longitudinal multi-center, randomized, superiority, controlled trial of Internet-based cognitive behavioural therapy (iCBT) versus treatment-as-usual (TAU) for negative experiences and posttraumatic stress following childbirth: the JUNO study protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39318241
Enrollment
130
Registered
2017-01-12
Start date
2013-09-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Post traumatic stress Mental and Behavioural Disorders Post-traumatic stress disorder

Interventions

Women with negative experiences from childbirth are included and randomized to either iCBT or TAU. The iCBT presents in two steps. iCBT step 1 is presented in six modules and includes minimal therapeu
talk about the birth experience and present symptoms etc.). iCBT step 2 consists of eight modules with extended therapeutic support offered to the participants who after step 1 have symptoms of PTSD.

Sponsors

Uppsala Universitet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Women aged 18 or over who are giving birth

Exclusion criteria

Exclusion criteria: 1. Severe mental illness 2. Ongoing CBT treatment 3. Intrauterine fetal deaths 4. Stillbirths 5. Neonatal deaths 6. Difficulties understanding Swedish 7. Unable to use internet

Design outcomes

Primary

MeasureTime frame
Assessed at baseline, 6 weeks, 14 weeks, 1 year, 2 year, 3 years and 4 years: 1. Post-traumatic stress symptoms related to childbirth, measured using the Traumatic Event Scale (TES) 2. Symptoms of depression, measured using the Edinburgh Postnatal Depression Scale (EPDS)

Secondary

MeasureTime frame
Assessed at baseline, 6 weeks, 14 weeks, 1 year, 2 year, 3 years and 4 years: 1. Quality of life and well-being, measured using the Satisfaction with Life Scale (SWLS) 2. Functional health and well-being, measured using the Short Form Health Survey – 36 (SF-36) 3. Thoughts and actions individuals use to cope with a stressful event, measured using the Ways of Coping Questionnaire (WCQ) 4. Feelings and attitudes towards communication in the relationship, measured using the communication subscale from the Evaluation and Nurturing Relationship Issues, Communication and Happiness (ENRICH) 5. Relationship quality, measured using the Revised Dyadic Adjustment Scale (RDAS) 6. Parent–infant bonding disorders, measured using the Postpartum Bonding Questionnaire (PBQ) 7. Health outcome, measured using the EuroQol 5D (EQ-5D) The partner also answers WCQ, PBQ, SWLS, R-DAS, the communication subscale from ENRICH, EQ5D, SF-36 and the Hospital Anxiety and Depression Scale at the same time points as above

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026