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Clinical Trials/NCT04183582
NCT04183582
Unknown
Not Applicable

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

National Society for the Prevention of Cruelty to Children1 site in 1 country60 target enrollmentDecember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postnatal Depression
Sponsor
National Society for the Prevention of Cruelty to Children
Enrollment
60
Locations
1
Primary Endpoint
Generalised Anxiety Disorder Questionnaire (GAD7)
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 2019
End Date
September 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

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

Outcomes

Primary Outcomes

Generalised Anxiety Disorder Questionnaire (GAD7)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Ages and Stages Questionnaire (ASQ)(Data collected when child is 1 year and 2-2.5years)

Study Sites (1)

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