Anxiety disorders (post-traumatic stress disorder, obsessive-compulsive disorder, social anxiety disorder, panic disorder) in pregnant women Mental and Behavioural Disorders Anxiety disorders
Conditions
Interventions
Women taking part will receive either intensive CBT (IN-CBT) or standard CBT for their anxiety disorder. They will be randomly allocated to one of these two treatments and each arm consists of individ
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 26/11/2019: 1. Women over the age of 18 years 2. A current primary anxiety disorder according to DSM-V criteria OCD, PTSD, Social anxiety or panic disorder) 3. Pregnant (12 weeks – 25 weeks) 4. Eligible to be seen under Lambeth, Lewisham, Southwark, Croydon IAPT services 5. Available for either intensive or weekly treatment 6. Either not on psychotropic medication or on a stable dose of medication for at least six weeks with no plans to change this during the intervention _____ Previous inclusion criteria: 1. Women over the age of 18 2. A current primary anxiety disorder according to DSM-V criteria OCD, PTSD, Social anxiety or panic disorder) 3. Pregnant (12 weeks – 20 weeks) 4. Eligible to be seen under Lambeth, Lewisham, Southwark, Croydon IAPT services 5. Available for either intensive or weekly treatment 6. Either not on psychotropic medication or on a stable dose of medication for at least six weeks with no plans to change this during the intervention
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 26/11/2019: 1. Women with a primary DSM-V depressive disorder, affective or psychotic disorder or current problems with substance abuse 2. Women with ‘complex PTSD’ (prolonged multiple traumas affecting a number of domains) 3. Women who have high-risk conditions requiring significant additional management (e.g. Multiple Sclerosis, Lupus, Polycystic Ovary Syndrome) 4. Women who are receiving psychological therapy elsewhere 5. Unable to read English adequately to complete questionnaires _____ Previous exclusion criteria: 1. Women with a primary DSM-V depressive disorder, affective or psychotic disorder or current problems with substance abuse 2. Women with ‘complex PTSD’ (prolonged multiple traumas affecting a number of domains) 3. Women who have a medically high-risk pregnancy at the time of recruitment 4. Women who are receiving psychological therapy elsewhere 5. Unable to read English adequately to complete questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 17/06/2020: This is a feasibility study so feasibility parameters (primarily recruitment and participation) are the main outcomes and one aim is to determine the primary outcome of a full-scale trial. 1. Recruitment rate defined as the number of participants recruited/month. An acceptable recruitment rate would be at least 3 participants/month 2. Acceptability of randomisation. A take-up of >70% of eligible participants is required to be deemed feasible. 3. If the intervention is received as intended in both arms in terms of being the intended mode of treatment and treatment fidelity using a content checklist. A minimum of 70% of participants in the trial would need to complete >60% of each intervention in hours for each to be deemed feasible, i.e. 7.5 hours out of 12. For completers in the intensive arm, these treatment hours (8 out of 10 hours) will need to be completed in the two-week window for IN-CBT to be considered to be delivered as intended 4. Acceptability of both interventions to participants; this will be determined by qualitative investigation, a brief rating scale asking if the treatment was useful at the end of treatment and numbers completing treatment 5. Participation and data completion at 3-month outcome assessment; a follow-up rate of >70% is required to determine feasibility 6. Acceptability of assessment measures to participants; this will be determined by qualitative interview and brief rating scales asking if it was useful and clear Previous primary outcome measures: This is a feasibility study so feasibility parameters (primarily recruitment and participation) are the main outcomes and one aim is to determine the primary outcome of a full-scale trial. 1. Recruitment rate defined as the number of participants recruited/month. An acceptable recrui | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/11/2019: Measured at pre-treatment baseline assessment, every treatment session, after the first 2 hours of treatment, late pregnancy follow up session, 1-month postnatal follow-up session, 3 months outcome: 1. Anxiety measured using GAD-7. This is the potential primary outcome measure of a full-scale trial 2. Depression symptoms measured using PHQ-9 3. Impact of a person’s mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure and personal or family relationships measured using the Work and Social Adjustment Scale 5. Disorder specific measures: one of the following will be used depending on primary disorder. 5.1. OCD symptoms measured using the Obsessive-Compulsive Inventory-Revised (OCI) 5.2. Panic. Avoidance of a range of specific situations over the last week measured using the Mobility Inventory (alone) 5.3. PTSD symptoms measured using the Impact of Events Scale (IES) 5.4. Social Phobia severity measured by the Social Phobia Inventory (SPIN) Measured after the first 2 hours of treatment only: 6. Therapeutic alliance between participant and therapist measured using the Working Alliance Inventory – Short Revised Measured at pre-treatment baseline assessment, late pregnancy follow up session, 1-month postnatal follow-up session: 7. Pregnancy anxiety measured using the Pregnancy-Related Anxiety Questionnaire (PRAQ) Measured at 1-month postnatal follow-up session, 3 months outcome: 8. Maternal perception of her felt bonding with the infant measured using the Postpartum Bonding Questionnaire (PBQ) Measured at 3 months outcome only: 9. Mother-Infant Interactions captured in a 3-minute vide | — |
Countries
England, United Kingdom
Contacts
Public ContactFiona Challacombe
Outcome results
None listed