Condition category
Mental and Behavioural Disorders
Date applied
28/04/2016
Date assigned
12/01/2017
Last edited
09/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Childbirth can be associated with both positive and negative psychological wellbeing. About 20-50% of women report symptoms that indicate some aspect of their childbirth as negative. Overall, up to 7% develop post-traumatic stress disorder after childbirth. Among many consequences, post-traumatic stress symptoms due to childbirth may affect the bonding between mother and child, cause depression for the mother, and cause fear of having more children. The aim of this study is to assess the effect of psychological treatment via the internet for women who had a negative birth experience (this includes women with emergency caesarian and major bleeding after childbirth). If this internet treatment is effective, it offers a great opportunity for other women with the same experiences, potentially at a low cost.

Who can participate?
Women aged 18 or over who are giving birth

What does the study involve?
Participants answer questionnaires on the internet after which they are randomly allocated to receive either internet treatment (cognitive behavior therapy) or treatment as usual. The internet treatment group receive a 6-week treatment that involves education about symptoms and psychological techniques that are aimed at coping and reducing their symptoms. The treatment is delivered via recorded sessions (movie clips) and participants can also read these sessions via the internet. Participants are also assigned homework every week. Women who have full PTSD at the end of these 6 weeks of treatment are offered a more individualized internet CBT program. This treatment phase consists of 8 weeks of treatment. All participants are asked to complete questionnaires after 6 weeks, 14 weeks and then annually up to 4 years.

What are the possible benefits and risks of participating?
Participants who receive the CBT treatment hopefully experience reduced anxiety and depression, higher quality of life and a quicker recuperation after the negative child birth experience. The assessment phase might increase participant’s reflections about the childbirth experience and their current situation. All women have full access to standard care throughout the study. A PTSD treatment may increase anxiety during the treatment and this is expected. Participants are in contact with a research assistant and a psychologist during treatment and are advised or/and referred to further care if needed.

Where is the study run from?
1. Linköpings University Hospital (Sweden)
2. Örebro University Hospital (Sweden)
3. Falu Lasarett (Sweden)
4. Uppsala Akademiska University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
January 2012 to December 2022

Who is funding the study?
Regional Research Council (Sweden)

Who is the main contact?
Prof. Agneta Skoog Svanberg
agneta.skoog_svanberg@kbh.uu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Agneta Skoog Svanberg

ORCID ID

Contact details

Department of Women's and Childrens Health
Akademiska Hospital
Uppsala
75185
Sweden
+46 (0)708 251 389
agneta.skoog_svanberg@kbh.uu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 1

Study information

Scientific title

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

Acronym

JUNO

Study hypothesis

iCBT is better than treatment as usual (TAU) regarding post traumatic stress symptoms and depression

Ethics approval

Regional Ethics Review Board in Uppsala, Sweden, 20/03/2013, dnr 2012-495

Study design

Interventional longitudinal multicenter superiority randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Post traumatic stress

Intervention

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 therapeutic support. The partners of the included women are invited to take part in the iCBT step 1 intervention. The partner receives identical content and a ‘partner instruction´with specific tasks to perform that aims at supporting the mother (support and make room for practice; reflective listening; 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. Assessments are made at baseline and post and follow-up assessments are taken at 1, 2, 3 and 4 years after baseline.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

04/01/2012

Overall trial end date

31/12/2022

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 18 or over who are giving birth

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

N=130 patients with negative experiences

Participant 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

Recruitment start date

01/09/2013

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköpings University Hospital
58750
Sweden

Trial participating centre

Örebro University Hospital
70362
Sweden

Trial participating centre

Falu Lasarett
79137
Sweden

Trial participating centre

Uppsala Akademiska University Hospital
Department of Women's and Childrens Health Akademiska Hospital
Uppsala
75185
Sweden

Sponsor information

Organisation

Uppsala Universitet

Sponsor details

Women and Children's Health
Akademiska Sjukhuset
Uppsala
SE-751 85
Sweden
+46 18 611 00 00
kbh@kbh.uu.se

Sponsor type

University/education

Website

www.kbh.uu.se

Funders

Funder type

Research council

Funder name

Regional Research Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of iCBT +TAU versus TAU will be published on two occasions; first at 1 year follow up and second at 4 years follow up. Ancillary publications to be confirmed at a later date.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Agneta Skoog Svanberg (agneta.skoog_svanberg@kbh.uu.se).

Intention to publish date

31/12/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes