Behavioural Activation (BA) for Postnatal Depression in Blackpool

Postnatal Depression Clinical Trial

— BA  

Official title:

A Two Phase Pilot of a Behavioural Activation (BA) Programme Specifically Adapted to Support Women Experiencing Postnatal Low Mood in Blackpool

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04183582
• Other study ID #: BBS001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: September 2021

Study information

• Verified date: November 2019
• Source: National Society for the Prevention of Cruelty to Children
• Contact: Miss E Lowrie, PhD
• Phone: 01253 476611
• Email: Emma.CECD[@]nspcc.org.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Is Behavioural Activation feasible, acceptable and potentially effective for mothers experiencing post natal depression in Blackpool?

Phase 1: A series of single case studies which aim to examine and refine a) the appropriateness of the programme to women in Blackpool b) the suitability of BA as part of a stepped-care approach to perinatal mental health within the Health Visitor pathway and c) the delivery of the programme in practice.

Phase 2: A preliminary single group study examining the quantitative outcomes for participating women (i.e. symptoms of depression, anxiety and general mood, parental stress, responsiveness, and behavioural avoidance and activation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18 years or older

• Score between 10-19 on PhQ9

• Have given birth within the last 6 months

• Willing to engage in a psychological therapy

• Informed, prepared and safe to participate in the programme

• Able to understand spoken and basic written English

Exclusion Criteria:

• Under 18 years old

• Score under 10 or over 19 on the PHQ9

• Receiving another from of psychological treatment for depression

• Unwilling to engage in a psychological therapy

• Another primary area of difficulty which takes precedence over the current programme (e.g.substance dependency disorders, suicidal crises, frequent, serious and deliberate self-harm, acute threat in the form of serious interpersonal violence from a partner or friend or family member, and evidence of more serious mental health disorders which may require additional support, i.e., psychotic disorders, Bipolar Disorder

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

Behavioral:
• Behavioural Activation
Behavioural Activation is a treatment for depression, the current programme has been adapted to suit the needs of postnatal women Session 1: Getting Started Session 2: Identifying Triggers, Reactions and Avoidance Patterns (TRAPs) Session 3: Turning TRACs in to Triggers, Reactions and Alternative Coping (TRACs) Session 4: Support and Communication Session 5: Being a "Good Enough" Mum Session 6: Staying Well

Locations

Country	Name	City	State
United Kingdom	Centre for Early Child Development	Blackpool

Sponsors (1)

Lead Sponsor	Collaborator
National Society for the Prevention of Cruelty to Children

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edinburgh Postnatal Depression Scale (EPDS)	The EPDS is a 10-item measure which assesses low mood and symptoms of depression. It has been designed specifically for women in the postnatal period.	Baseline, 2 week (x2), 3 weeks (x2), 4 weeks, 5 weeks, 6 weeks
Primary	Patient Health Questionnaire (PHQ9)	The PHQ9 is a 9-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of depression.	Baseline, 6 weeks, 18 weeks, 1 year
Primary	Generalised Anxiety Disorder Questionnaire (GAD7)	The GAD7 is a 7-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of anxiety.	Baseline and 6 weeks
Primary	Parental Stress Scale (PSS)	The PSS is a self-report scale that intended to assess parental stress. It contains 18 items representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal development) and negative components (demands on resources, opportunity costs and restrictions).	Baseline and 6 weeks
Primary	Maternal Infant Responsiveness Instrument (MIRI)	The MIRI is a 22-item scale designed to measure the parent's feelings about the infant and an appraisal of their infant's responsiveness.	Baseline and 6 weeks
Primary	Behavioural Activation for DEpression Scale (BADS)	The BADS is a 25-item scale which can track change in behaviours which are hypothesised to underlie depression which are specifically targeted through Behavioural Activation. It comprises of four subscales; activation, avoidance/rumination, work/school impairment and social impairment.	Baseline and 6 weeks
Primary	Snaith-Hamilton Pleasure Scale (SHAPS)	The SHAPS is a 14-item measure of anhedonia (the degree to which an individual is able to experience pleasure). It comprises of four subscales which measure response/hedonic experiences; interests/past-times, social interaction, sensory experiences, food/drink.	Baseline and 6 weeks
Secondary	Ages and Stages Questionnaire (ASQ)	Nationally mandated data collected by Health Visitors in the UK to assess children's development. This includes five key areas of development, communication, gross motor, fine motor, problem solving, and personal-social.	Data collected when child is 1 year and 2-2.5years