Behavioural Activation (BA) for Postnatal Depression in Blackpool (BA)

November 28, 2019 updated by: National Society for the Prevention of Cruelty to Children

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, 18 weeks, 1 year
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.
Baseline and 6 weeks
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).
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ages and Stages Questionnaire (ASQ)
Time Frame: 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.
Data collected when child is 1 year and 2-2.5years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Baseline, 2 week (x2), 3 weeks (x2), 4 weeks, 5 weeks, 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Society for the Prevention of Cruelty to Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

November 28, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

To be confirmed with programme developers, research team and potential academic partners

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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