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临床试验/NCT04244617
NCT04244617已完成不适用

Peer-supported Internet Mediated Psychological Treatment for Adults With Anxiety Disorders in Primary Care

Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
试验地点
1
主要终点
Changes in feelings of empowerment

研究概览

简要总结

This study evaluates the effect and experience of peer-support in internet mediated ACT (Acceptance and Commitment therapy) in an explorative pilot study with mixed method design conducted in primary care. Peer-supporters are certified support persons with personal experience of mental health problems and the process of rehabilitation, which becomes professionally active in care and support to patients in their recovery

详细描述

The study is a mixed methods design consisting of an un-controlled pragmatic effectiveness study combined with semi-structured interviews in order to investigate the participant´s experience of treatment. Participants were recruited from patients who were referred to a central unit for internet- CBT (Cognitive Behavioral therapy) in primary care in Västra Götaland region, Sweden. Peer-supporters were recruited through a swedish patient organization. Participants were adults 18 years of age or older with an anxiety disorder.

All participants were interviewed by a psychologist with a diagnostic instrument, a structured interview called PRIME-MD, before starting treatment. After the interview, all patients who were offered iCBT and met the inclusion criteria were requested to participate in the study.

Patients who accepted inclusion were guided by both a psychologist and a peer-support in the iCBT treatment used in the study. The iCBT treatment program used is a transdiagnostic program aimed at treating people with mild to moderate anxiety problems.

Quantitative data about psychosocial symptoms were collected, and qualitative data about the participants experience of treatment were collected through semi-structured interviews.

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

入排标准

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

入选标准

  • participants must have reached the age of 18
  • have access to a computer with internet Connection
  • speak and understand Swedish
  • meet the diagnostic criteria for an anxiety disorder (social anxiety, GAD, panic disorder, obsessive-compulsive disorder, or unspecified anxiety disorder).

排除标准

  • have started medication or have made major changes regarding their medication in the past few months
  • have serious suicidal ideation or suicide plans
  • are expected to have complex problems or be in need of other care
  • are under any other psychological treatment during the time of the treatment period.

结局指标

主要结局

Changes in feelings of empowerment

时间窗: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up

Empowerment is measured with the Empowerment Scale (Rogers, Chamberlin, Ellison \& Crean, 1997). The scale consists of 28 items which are answered on a four-point likert scale. Score ranges between 28 and 112. Higher scores indicates that the person feels more empowered.

Change in Anxiety symptoms

时间窗: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up

Anxiety is measured with the GAD-7 instrument (Generalized Anxiety Disorder 7 item scale). The scale consists of 7 items. The score ranges from 0 to 21, with higher scores indicating more anxiety symptoms. There are thresholds for mild, medium and severe anxiety (Spitzer, Kroenke, Williams \& Löwe 2006).

Change in Depressive symptoms

时间窗: Baseline (Pre-treatment), post treatment (after 8 weeks) and by 3 month follow up

Symptoms of depression is measured with Madrs-s (Montgomery Åsberg Depression Rating Scale; Montgomery \& Åsberg, 1979). The instrument consists of 9 items. Scores ranges from 0 to 60, with higher scores indicating more depressive symptoms. There are cut-off points for symptom severity.

Change in symptoms of psychological distress

时间窗: Baseline (Pre-treatment) and post treatment (after 8 weeks) (Since this instrument is provided in connection with the modules in the treatment program

Symptoms of psychological distress is measured with the CORE-10 (Barkham et al., 2012). Score ranges from 0 to 40, with higher scores indicating more psychological distress. The instrument consists of 10 items and has clinical cut-off scores for general psychological distress.

次要结局

未报告次要终点

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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