Depression: a trial of antenatal guided self help for women

• Register: ISRCTN
• Last refreshed on: 17 August 2020
• Main ID: ISRCTN83768230
• Date of registration: 08/08/2014
• Prospective Registration: Yes
• Primary sponsor: King's College London (UK)
• Public title: Depression: a trial of antenatal guided self help for women
• Scientific title: Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN)
• Date of first enrolment: 30/10/2014
• Target sample size: 110
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN83768230
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment (Treatment)
• Phase: Phase II

Countries of recruitment

United Kingdom

Contacts

• Name: Kylee Trevillion

Key inclusion & exclusion criteria

Inclusion criteria:
1. Pregnant women, up to 26 weeks gestation
2. Aged 16 years or older
3. Meeting the criteria for DSM­-IV depression

Exclusion criteria:
1. Pregnant women who are unable to complete the trial questionnaires/workbook in English or provide informed consent
2. Have psychosis, borderline personality disorder, a current eating disorder, current post-traumatic stress disorder, or suicidality and/or are receiving secondary mental health care, psychological therapies or antidepressants


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Topic: Mental Health, Reproductive health and childbirth; Subtopic: Depression, Reproductive Health and Childbirth (all Subtopics); Disease: Depression, Reproductive Health & Childbirth
Pregnancy and Childbirth

Intervention(s)

Women will be randomly assigned to:
1. Guided Self Help (delivered by Psychological Wellbeing Practitioners) plus usual care
2. Usual care alone (i.e., treatment as usual)

Guided Self Help, Details: Existing Guided Self Help materials used in psychological services for the treatment of depression are being modified for pregnancy. The Guided Self Help (with usual care) intervention for antenatal depression is being delivered by NHS Psychological Wellbeing Practitioners (PWPs). The intervention comprises an initial session at the beginning of therapy, followed by up to eight 30-minute sessions. An additional session will also be conducted, at six to eight weeks post-delivery (i.e. before the post-delivery research outcomes are collected)

Primary Outcome(s)

Depression, measured using the Edinburgh Postnatal Depression Scale - depressive symptoms at baseline and 14 weeks

Secondary Outcome(s)

1. Anxiety, measured using the Generalized Anxiety Disorder Scale (GAD-7) at baseline and 14 weeks
2. Depression, measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and 14 weeks and the Edinburgh Postnatal Depression Scale and Whooley items at 3 months post-delivery
3. Health-related quality of life, measured using the Short Form Health Survey (SF-6D) at baseline, 14 weeks and 3 months post-delivery
4. Service contacts, measured using the Adult Service Use Schedule at 14 weeks and 3 months post-delivery
5. Parenting stress, measured using the Postpartum Bonding Questionnaire at 3 months post-delivery

Secondary ID(s)

17048

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

NRES Committee London-Camberwell St Giles, 11/06/2014, ref: 14/LO/0597

Results

• Results available: Yes
• Date Completed: 30/06/2017