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临床试验/NCT02819986
NCT02819986已完成不适用

Effectiveness and Feasibility of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2016年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Impact of PGAP on disability (participant perception)

研究概览

简要总结

The purpose of the present study is to determine the effectiveness and feasibility of the Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders. PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help individuals return to life roles including readiness to return to work. PGAP has been shown to be effective with some chronic health conditions however has not been specifically studied in mental health populations. The study consists of 10 one hour weekly therapy sessions that focus on reducing psychosocial risk factors that result in disability through the use of goal setting, activity planning and activation, monitoring and challenging thoughts about return to work, and problem solving. Participants will also be asked to complete short self-report questionnaires as well as a semi-structured interview about the participants anxiety, mood, impact of disability, and current functioning at the beginning of session one and within two weeks after session 10. Two short questionnaires will also be completed at each session measuring the degree to which the participants daily life impacts and is affected by anxiety or mood symptoms.

详细描述

The purpose of the present study is to determine the effectiveness of the Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders. PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help individuals return to life roles including readiness to return to work. PGAP has been shown to be effective with some chronic health conditions however has not been specifically studied in mental health populations.

The study consists of 10 one hour weekly therapy sessions with a clinician and follow the PGAP manual. The therapy sessions focus on reducing psychosocial risk factors that result in disability through the use of goal setting, activity planning, activation and re-engagement in activities, monitoring and challenging thoughts about return to work, and problem solving. Participants are also encouraged to participate in homework which involves daily activity planning, participating in planned activities, and tracking the activities completed. Participants will also be asked to complete short self-report questionnaires as well as a semi-structured interview about the participants anxiety, mood, impact of disability, and current functioning at the beginning of session one and within two weeks after session 10. Two short questionnaires will also be completed at each session measuring the degree to which the participants daily life impacts and is affected by anxiety or mood symptoms.

Our first hypothesis is that participants who receive PGAP will report significant reductions in functional disability as measured by self-report as well as by interview, decreases in self-reported work avoidance, increases in work readiness, and decreases in self-reported symptoms of anxiety and depression. Our second hypothesis is that mean reductions in the above-noted outcome variables will be similar in magnitude to those reported in published studies that have examined PGAP in chronic medically ill populations. Retention rates and satisfaction of the therapy will also be assessed to determine feasibility of implementing the program on a larger scale.

To examine the effectiveness of PGAP with participants with an anxiety or a mood disorder, the investigators will conduct a series of dependent sample t-tests on the outcome variables pre and post intervention. The investigators will also compare mean changes on the outcome variables to those in the published literature. The investigators will calculate retention rates with the aim of retaining more than 75% of participants, which is comparable to retention and drop out rates for psychotherapy trials with participants completing at least 8 out of 10 sessions or having returned to employment. Feasibility will also be measured by looking at satisfaction ratings. A minimal standard will be an average satisfaction rating across participants of midpoint (neutral) or above in terms of the therapy received.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants will be
  • •between the ages of 18 and 65 years
  • •have a principle diagnosis of an anxiety or mood disorder
  • •have had changes in their work functioning, either currently not working due to their disability or on modified/reduced work.
  • •be registered outpatients of the Anxiety Treatment and Research Clinic or Outpatient Mood Disorders Program, St. Joseph's Healthcare Hamilton,
  • •are interested in return to work or have work related goals.

排除标准

  • •current significant substance use
  • •acute mental health (e.g. suicidality, psychosis, mania) that would interfere with the program completion

研究组 & 干预措施

Progressive Goal Attainment Program

Experimental

10 one hour weekly therapy sessions focused on behavioural interventions

干预措施: Progressive Goal Attainment Program (Behavioral)

结局指标

主要结局

Impact of PGAP on disability (participant perception)

时间窗: one year

Level of disability will be measured using a modified version of the Pain Disability Index ( a 7 item self-report measure).

次要结局

  • PGAP retention rates(one year)
  • Impact of PGAP on fear avoidance beliefs(one year)
  • Impact of PGAP on disability (clinician report)(one year)
  • Impact of PGAP on role functioning(one year)
  • Impact of PGAP on symptom change(one year)
  • Impact of PGAP on level of interference from mood and anxiety symptoms(one year)
  • Satisfaction with the PGAP(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tanja Colonerus

Priniciple Investigator

St. Joseph's Healthcare Hamilton

研究点 (1)

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