Behavioural Activation (BA) for Postnatal Depression in Blackpool

Study Overview
=================
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.

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

Conditions
-----------------
Postnatal Depression

Intervention / Treatment
-----------------
* Behavioral: Behavioural Activation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Experimental Arm - single group study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Single arm group receiving Behavioural Activation, a facilitated self-help programme delivered by trained Health Visitors as six one hour sessions over four weeks. | Behavioral: Behavioural Activation<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychoeducation, Mental Health, Depression, Postnatal