Pregnant women (16-28 weeks gestation) with high levels of repetitive negative thinking and up to a moderate level of anxiety Mental and Behavioural Disorders
Conditions
Interventions
Randomization will take place via Avegen's randomization system. Participants will be randomized individually with equal allocation to the two arms, stratified by site (GSTT vs KCH vs KCL), parity (0
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women between 16-28 weeks gestation 2. Aged 18 years or older 3. Based in the United Kingdom 4. High levels of RNT (RTQ-10 [trait] =32; McEvoy et al., 2014) 5. Anxiety up to only a moderate level (GAD-7 <15) 6. Ability to understand oral and written English 7. Normal or corrected-to-normal hearing and vision 8. Ability to access the internet on a PC, laptop, or tablet (rather than a mobile phone) 9. Provision of an email address and phone number for contact with the team
Exclusion criteria
Exclusion criteria: 1. Current psychiatric diagnosis (this will be assessed via the clinical interview schedule revised (CIS-R; Lewis & Pelosi, 1992) which participants will complete as part of the screening questionnaire as well as via general questions about a current diagnosis of a psychotic disorder, eating disorder, substance use disorder or personality disorder) 2. Past diagnosis of a psychotic disorder (e.g., schizophrenia), bipolar disorder, an eating disorder, a substance use disorder (e.g., alcohol dependence) and/or a personality disorder (e.g., borderline personality disorder) 3. Current or recent history of risk: current suicidal intent (PHQ-9 item 9 >1), suicide attempt <2 years and/or self-harm <1 year 4. History of stillbirth, neonatal death, or multiple (i.e., =3) miscarriages 5. Current participation in another study that is investigating a treatment for a mental health problem 6. Not registered with a GP in the UK
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T2 anxiety measured by the Generalised Anxiety Disorder Questionnaire-7 (GAD-7) at 8 weeks post-randomisation; 24-36 weeks gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary clinical endpoints will all be presented as mean differences in outcomes between the intervention (RELAX + usual care) and control (usual care) arms adjusting for baseline. These endpoints are: 1. Anxiety measured using GAD-7 at 36-weeks post-randomisation (T3) 2. Depression measured using Patient Health Questionnaire-9 (PHQ-9) at 8 weeks post-randomisation (T2) 3. Depression measured using PHQ-9 at 36 weeks post-randomisation (T3) 4. RNT measured using Repetitive Thinking Questionnaire-10 (RTQ-10) (trait) at 8 weeks post-randomisation (T2) 5. RNT measured using RTQ-10 (trait) at 36 weeks post-randomisation (T3) 6. Trait worry measured using Penn State Worry Questionnaire (PSWQ) at 8 weeks post-randomisation (T2) 7. Trait worry measured using PSWQ at 36 weeks post-randomisation (T3) 8. Perinatal depression measured using Edinburgh Postnatal Depression Scale (EPDS) at 8 weeks post-randomisation (T2) 9. Perinatal depression measured using EPDS at 36 weeks post-randomisation (T3) 10. Perinatal anxiety measured using Perinatal Anxiety Screening Scale (PASS) at 8 weeks post-randomisation (T2) 11. Perinatal anxiety measured using PASS at 36 weeks post-randomisation (T3) 12. Work and social functioning measured using Work and Social Adjustment Scale (WSAS) at 8 weeks post-randomisation (T2) 13. Work and social functioning measured using WSAS at 36 weeks post-randomisation (T3) | — |
Countries
England, United Kingdom
Contacts
Public ContactBrittannia Volkmer
Outcome results
None listed