Behavioural Activation (BA) for Postnatal Depression in Blackpool

Not Applicable

• Conditions: Postnatal Depression
• Interventions: Behavioral: Behavioural Activation

• Registration Number: NCT04183582
• Lead Sponsor: National Society for the Prevention of Cruelty to Children

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-28
• Last Update Submitted: 2019-11-28
• Study Start: 2019-12
• Study First Posted: 2019-12-03
• Last Update Posted: 2019-12-03
• Primary Completion: 2020-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Behavioural Activation	Single arm group receiving Behavioural Activation, a facilitated self-help programme delivered by trained Health Visitors as six one hour sessions over four weeks.

Primary Outcome Measures

Name	Time	Method
Generalised Anxiety Disorder Questionnaire (GAD7)	Baseline and 6 weeks	The GAD7 is a 7-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of anxiety.
Behavioural Activation for DEpression Scale (BADS)	Baseline and 6 weeks	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.
Patient Health Questionnaire (PHQ9)	Baseline, 6 weeks, 18 weeks, 1 year	The PHQ9 is a 9-item multi-purpose instrument which can be used to screen, diagnose, monitor and assess symptoms of depression.
Maternal Infant Responsiveness Instrument (MIRI)	Baseline and 6 weeks	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.
Snaith-Hamilton Pleasure Scale (SHAPS)	Baseline and 6 weeks	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.
Parental Stress Scale (PSS)	Baseline and 6 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Ages and Stages Questionnaire (ASQ)	Data collected when child is 1 year and 2-2.5years	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.

Trial Locations

Locations (1)

Centre for Early Child Development; 🇬🇧 Blackpool, United Kingdom