Clinical trial NCT04183582: Behavioural Activation (BA) for Postnatal Depression in Blackpool
Official title: A Two Phase Pilot of a Behavioural Activation (BA) Programme Specifically Adapted to Support Women Experiencing Postnatal Low Mood in Blackpool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postnatal Depression
Keywords: Psychoeducation, Mental Health, Depression, Postnatal
Lead sponsor: National Society for the Prevention of Cruelty to Children
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Experimental Arm - single group study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ9)
timeFrame: Baseline, 6 weeks, 18 weeks, 1 year
measure: Generalised Anxiety Disorder Questionnaire (GAD7)
timeFrame: Baseline and 6 weeks
measure: Parental Stress Scale (PSS)
timeFrame: Baseline and 6 weeks
measure: Maternal Infant Responsiveness Instrument (MIRI)
timeFrame: Baseline and 6 weeks
measure: Behavioural Activation for DEpression Scale (BADS)
timeFrame: Baseline and 6 weeks
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Ages and Stages Questionnaire (ASQ)
timeFrame: Data collected when child is 1 year and 2-2.5years
Other outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, 2 week (x2), 3 weeks (x2), 4 weeks, 5 weeks, 6 weeks
Locations:
city: Blackpool
country: United Kingdom
facility: Centre for Early Child Development
Study officials:
References: