A Two Phase Pilot of a Behavioural Activation (BA) Programme Specifically Adapted to Support Women Experiencing Postnatal Low Mood in Blackpool
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Generalised Anxiety Disorder Questionnaire (GAD7)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Behavioural Activation (Behavioral)
结局指标
主要结局
Generalised Anxiety Disorder Questionnaire (GAD7)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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).
次要结局
- Ages and Stages Questionnaire (ASQ)(Data collected when child is 1 year and 2-2.5years)