Behavioural Activation (BA) for Postnatal Depression in Blackpool

NCT04183582 | Unknown

• 1 other identifier: BBS001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postnatal Depression

Keywords

Psychoeducation, Mental Health, Depression, Postnatal

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Ages and Stages Questionnaire (ASQ)

  Data collected when child is 1 year and 2-2.5years

Other Outcomes (1)

• Edinburgh Postnatal Depression Scale (EPDS)

  Baseline, 2 week (x2), 3 weeks (x2), 4 weeks, 5 weeks, 6 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Behavioural Activation BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Society for the Prevention of Cruelty to Children: lead

Study Sites (1)

Centre for Early Child Development

Blackpool, United Kingdom

Location

MeSH Terms

Conditions

Depression, Postpartum; Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Central Study Contacts

Miss E Lowrie, PhD

CONTACT

01253 476611; Emma.CECD@nspcc.org.uk

Mrs C Law, MSc

CONTACT

01253 476192; Clare.CECD@nspcc.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental Arm - single group study

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 3, 2019
• Study Start: December 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)