跳至主要内容
临床试验/NCT05344326
NCT05344326招募中不适用

Development and Piloting of a Low Intensity Cognitive Analytic-Informed Guided Self-help for Depression to be Used Within Increasing Access to Psychological Therapies (IAPT)

University of Sheffield1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年11月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
13
试验地点
1
主要终点
Work and Social Adjustment Scale - WSAS

研究概览

简要总结

Cognitive analytic therapy (CAT) is used within mental health services as a treatment for a range of mental health difficulties. Recent research has adapted CAT to be used as guided self-help for anxiety within Increasing Access to Psychological Therapies (IAPT). IAPT is a mental health service. Guided self help-CAT (CAT-GSH) is delivered by mental health professionals called Psychological Wellbeing Practitioners (PWPs). This current study aims to develop and pilot a CAT-GSH manual for depression for use in the same context and practitioners. Stage one uses past research and consultation meetings to help develop the treatment. Stage two will use different approaches to explore the acceptability and outcomes of the intervention.

详细描述

Aims Phase One

  1. Develop a CAT-informed GSH manual (CAT-GSH) for depression Phase Two
  1. Pilot CAT-SH within IAPT setting
  2. To explore the impact of CAT-GSH on outcomes
  3. To investigate the acceptability of CAT-GSH

Method Stage One Past research and consultation meetings will be consolidated into a matrix. This will inform the development of the treatment manual.

Stage Two A mixed-methods, small N case series design will be utilized to pilot the CAT-GSH manual within IAPT services. Three Psychological Wellbeing Practitioners (PWP) and 10 service users will be recruited from Barnsley IAPT service. The PWPs will be provided a two-day training course before the study begins. This will cover information regarding the CAT-GSH, data management, and the protocol. To recruit 10 service user participants, it is predicted the first 60 people on the Barnsley IAPT waiting list would need to be screened to account for eligibility criteria, preference, and attrition.

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

The PWP and service users will be aware of the intervention

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Depression is the main problem
  • •They score above the clinical cut off (10 points) on the Patient Health Questionnaire (PHQ9; Kroenke and Spitzer, 2002)
  • •Aged between 18 - 65
  • •Would prefer to use CAT-GSH over other interventions
  • •Consent to participate in study
  • •Can engage with reading materials

排除标准

  • •Patients who would normally be 'stepped up' due to complexity and risk
  • •Patients are receiving other therapies
  • •Substance users unable to abstain during sessions

研究组 & 干预措施

CAT-GSH

Experimental

Participants, who provide informed consent, will be provided an assessment session, six fortnightly CAT-GSH sessions, and one follow-up session.

干预措施: Cognitive Analytic Therapy - Guided Self Help (CAT-GSH) (Other)

结局指标

主要结局

Work and Social Adjustment Scale - WSAS

时间窗: Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.

This scale measures social functioning.

Patient Health Questionnaire - PHQ9

时间窗: Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.

The PHQ9 is a 9-item self-administered questionnaire designed for detecting depression and is based on the DSM-IV criteria.

Generalised Anxiety Disorder Assessment - GAD 7

时间窗: Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.

The GAD7 is also widely used within primary care settings and is a self-reported screening tool for generalised anxiety disorder.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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