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临床试验/NCT03341364
NCT03341364撤回不适用

Acceptance and Commitment Based Group Therapy for Cancer Patients: a Pilot Study Comparing ACT-group Therapy With Individual ACT Therapy for Cancer Patients Experiencing Psychological Distress

Region Skane2 个研究点 分布在 1 个国家开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Region Skane
试验地点
2
主要终点
Change in Swedish Acceptance and Action Questionnaire (SAAQ)

研究概览

简要总结

This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Half of the participants will receive ACT in a group setting, while the other half will receive individual ACT.

详细描述

This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Participants will be recruited from referrals to the Cancer Rehabilitation Unit at Helsingborg Hospital, Sweden. A total number of 12-20 participants will be assigned to either the experimental group, receiving ACT group therapy, or the Active Control group, receiving individual ACT therapy. Both therapy interventions aim at increasing psychological flexibility. Sociodemographic as well as Medical information regarding their somatic disease will be collected at baseline assessment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

  • Age ≥ 18 years
  • Able to speak and understand the Swedish language
  • Cancer patients at hospitals in Skånevård Sund (geographical area)
  • Experience of psychological distress related to cancer diagnosis or cancer treatment
  • Stable and planned cancer treatment or no ongoing treatment

排除标准

  • Severe cognitive problems
  • Severe psychiatric disorder
  • Ongoing substance abuse

结局指标

主要结局

Change in Swedish Acceptance and Action Questionnaire (SAAQ)

时间窗: Baseline and end of treatment (baseline+3-16 weeks)

Measures self-reported psychological flexibility on a 7-point likert scale. The questionnaire includes a total of 6 items. Each item is scored 1-7 (1=never true, 7=always true), yielding a total between 7 and 42 where a higher number indicates lower psychological flexibility.

次要结局

  • Change in Swedish Acceptance and Action Questionnaire (SAAQ)(End of treatment (baseline + 3-16 weeks) and follow up (6 weeks after end of treatment))
  • Change in Generalized Anxiety Disorder 7 (GAD-7)(End of treatment (baseline+3-16 weeks) and follow up (6 weeks after end of treatment))
  • Change in Patient Health Questionnaire 9 (PHQ-9)(Baseline and end of treatment (baseline + 3-16 weeks))
  • Change in RAND 36-item Health Survey (RAND-36)(End of treatment (baseline+3-16 weeks) and follow-up (6 weeks after end of treatment))

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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