Priming Attachment Security Within an IAPT Setting
2019年7月13日 更新者：Charlotte Heathcote、University of Sheffield
Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study
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.
研究概览
地位
未知
条件
详细说明
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.
研究类型
介入性
注册 (预期的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
North Yorkshire
-
Harrogate、North Yorkshire、英国、hg12pw
- Harrogate IAPT Service
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Over age 18.
- Adequate English ability.
Exclusion Criteria:
- Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Inadequate English ability.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
Clients will engage in treatment as usual.
This involves low-intensity guided self-help behavioural activation for depression.
|
|
实验性的：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.
|
In addition to their treatment as usual (low-intensity guided self-help behavioural activation for depression), participants will complete an initial attachment security priming task during the first session with their allocated clinician. Participants will be prompted in their intervention workbook with a caption regarding what a secure attachment relationship represents. They will be asked to think of a person/ people with whom they feel they have this relationship, and list them. Following this, they are asked to plot these individuals on a diagram of concentric circles in relation to how close they feel this person is to them. The closer to the middle of the diagram the individual places each person, the closer they feel their relationship to that person is. Prior to each session with their clinician, they will be prompted to complete a repeated security priming task in order to increase feelings of security prior to therapy sessions. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Attendance
大体时间：Up to 8 weeks from the beginning to end of treatment
|
Number of therapy appointments booked versus number attended for each participant
|
Up to 8 weeks from the beginning to end of treatment
|
|
Dropout
大体时间：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
|
Up to 8 weeks from the beginning to end of treatment
|
|
Stepping-up to higher intensity services
大体时间：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
|
Up to 8 weeks from the beginning to end of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
大体时间：Weekly for up to 8 weeks from the beginning to end of treatment
|
Self-report measure of depression with total possible score ranging from 0 to 27.
Scores of 0-4 indicate minimal depression; 5-9 indicates mild depression; 10-14 indicates moderate depression; 15-19 indicates moderately severe depression; and 20-17 indicates severe depression.
|
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)
大体时间：Weekly for up to 8 weeks from the beginning to end of treatment
|
Self-report measure of anxiety with total possible scores between 0 to 21. Scores of 0-5 indicate mild anxiety; 6-10 indicates moderate anxiety; 11-15 indicates moderately severe anxiety; and 16-20 indicates severe anxiety.
|
Weekly for up to 8 weeks from the beginning to end of treatment
|
|
The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)
大体时间：Weekly for up to 8 weeks from the beginning to end of treatment
|
Self-report measure of impaired functioning with total possible scores of between 0-20.
Scores below 10 are associated with subclinical populations.
Scores between 10 and 20 indicate significant functional impairment but less severe clinical symptomatology.
Scores above 20 indicate moderately severe or worse psychopathology.
|
Weekly for up to 8 weeks from the beginning to end of treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：James Walton、Harrogate IAPT Service
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年8月1日
初级完成 (预期的)
2019年10月1日
研究完成 (预期的)
2019年10月1日
研究注册日期
首次提交
2019年6月17日
首先提交符合 QC 标准的
2019年7月13日
首次发布 (实际的)
2019年7月17日
研究记录更新
最后更新发布 (实际的)
2019年7月17日
上次提交的符合 QC 标准的更新
2019年7月13日
最后验证
2019年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 249633
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.