Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dropout
研究概览
简要总结
There is growing evidence that priming attachment security is associated with improved attitudes towards therapy, increased engagement and decreased levels of depression and anxiety. Within the Improving Access to Psychological Therapies (IAPT) programme a consistent problem has been identified of high dropout rates at step 2 services (i.e. where mild to moderate anxious and depressed patients receive guided self-help interventions). The current study incorporates a feasibility and pilot design. The feasibility element will explore issues related to study design to determine suitability for conducting a future randomised control trial (RCT). The pilot study will look at the processes outlined in the protocol to determine whether the study components all work together. Moreover, it will preliminarily aim to explore the effectiveness of the attachment security priming intervention on symptoms of depression and anxiety, as well as impaired functioning. Both elements of the study will determine whether any changes are needed to the study design or protocol, and whether a future RCT is suitable and necessary.
详细描述
The study is being conducted in an IAPT primary care service in North Yorkshire. The study will be recruiting 50 participants experiencing mild to moderate depression who are deemed suitable for 'behavioural activation' low intensity guided self-help intervention. Following telephone screening for intervention, clinicians will ask clients if they wish to hear more about participating in a research study. If participants say yes, their contact details will be passed on to the researcher who will send them the study information sheet and consent form in the post. If the participant consents to taking part in the research, they will be randomised to receive either treatment as usual (low-intensity guided self-help utilising behavioural activation for depression) or treatment with security priming intervention (treatment as usual with an additional security priming task). They will have between 6-8 sessions as routinely delivered within the service and will be asked to complete measures of depression, anxiety and impaired functioning on a sessional basis. The principal investigator at the study site will collect information regarding attendance to therapy, dropout rates, and 'stepping' clients up to higher-intensity therapies as primary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The participant will not explicitly be told which condition they are in by the researcher or the clinician working directly with them. However, they are likely to be able to infer this from the treatment being delivered, having read the information sheet regarding the study. The clinician working with the participant will be aware what condition they are in so that they are able to deliver the appropriate intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- •Adequate English ability.
排除标准
- •Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- •Inadequate English ability.
研究组 & 干预措施
Treatment as Usual
Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service.
干预措施: Treatment as Usual (Behavioural Activation) (Behavioral)
Treatment with Security Prime
Participants randomised to the experimental group will receive behavioural activation guided self-help intervention as is routinely delivered in the service with additional attachment security priming intervention.
干预措施: Treatment as Usual with Security Prime (Behavioral)
结局指标
主要结局
Dropout
时间窗: Up to 8 weeks from the beginning to end of treatment
Number of participants who drop out of therapy after attending at least one session of treatment
Stepping-up to higher intensity services
时间窗: Up to 8 weeks from the beginning to end of treatment
The number of participants in the study who are referred for a higher intensity form of therapy during their low-intensity therapy
Attendance
时间窗: Up to 8 weeks from the beginning to end of treatment
Number of therapy appointments booked versus number attended for each participant
次要结局
- The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)(Weekly for up to 8 weeks from the beginning to end of treatment)
- The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)(Weekly for up to 8 weeks from the beginning to end of treatment)
- The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)(Weekly for up to 8 weeks from the beginning to end of treatment)
研究者
Charlotte Heathcote
Trainee Clinical Psychologist
University of Sheffield