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临床试验/NCT02751749
NCT02751749已完成不适用

Chronic Pain and Emotional Problems: a Single Case Study of an Internet Based Self-help Treatment Based on CBT Principles and the Unified Protocol for Transdiagnostic Treatments

Örebro University, Sweden0 个研究点目标入组 12 人开始时间: 2015年12月1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
发起方
入组人数
12
主要终点
Overall Depression Severity and Impairment Scale (ODSIS)

研究概览

简要总结

The study uses a replicated randomized single case design. Participants were 12 individuals with chronic pain problems and residual problems after undergoing a multimodal pain rehabilitation. They also had comorbid emotional problems. Treatment consisted of 10 weeks of Internet delivered, therapist guided CBT based self-help treatment based on the Unified Protocol.

详细描述

The study uses a replicated randomized single case design. Twelve participants were recruited from three pain clinics and five primary care centers in different municipalities in central Sweden. The clinics and care centers provided addresses and sent a total of 600 letters with information regarding the study to patients who had completed a multimodal pain rehabilitation (MMR) at their facility within the last three years. Participants were also recruited via the Internet through an advertisement on Google Ads that was visible for two months. No reward was offered for taking part in the study. Potential participants were screened and provided demographic information on a secure internet based platform. Afterwards all screened individuals received a telephone call. Excluded individuals were informed about the reason for exclusion and given recommendations regarding alternative treatment options when indicated. Eligible participants were screened further using selected parts of the Mini International Neuropsychiatric Interview. They were also given more information about the study and invited to ask questions. Individuals who met selection criteria were randomized in blocks of four using randomizer.org and half participated in an initial pilot study while half participated in the treatment study reported here. Participants for the treatment study were thereafter randomized to either a short (five week) or a long (10 week) baseline as well as separately randomized to one of five therapists. Therapists were two clinical psychology students in their last year of training, one graduated clinical psychologist, one postgraduate clinical psychology fellow and one certified clinical psychologist. Participants gave written informed consent by sending in a form included in the initial information letter.

Participants were 12 individuals with chronic pain problems. The sample consisted of 9 females (75 %) and 3 males (25 %). Participants' age ranged from 30 to 60 (M= 47, sd= 9). See table 1 for further description of the participants. All participants had completed MMR within the past three years.

Participants for the treatment study filled in baseline measurements at between 3 and 10 time points. Baseline measurements were separated by at least five days. In connection with the last baseline measurement, participants filled out pretreatment measurements and started treatment, consisting of 10 weekly modules. Process measurements were filled out once every module, as well as longer measurements at mid- and post treatment. A follow-up was done via the platform after 3 months. Treatment consisted of 10 weeks of internet delivered, therapist guided CBT based self-help treatment based on the Unified Protocol.

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
否

入选标准

  • •Chronic pain problems (duration > 3 months)
  • •Depressive symptoms and/or anxiety symptoms (> 15 points on the Swedish Montgomery Åsberg Depression Schedule (MDRS-S) and/or > 7 points on the Overall Anxiety Symptoms and Impairment Scale, (OASIS))
  • •MMR within the last three years
  • •> 18 years
  • •Fluent in reading and writing Swedish, and
  • •Internet access.

排除标准

  • •Ongoing or planned psychological treatment delivered by a psychologist or a psychotherapist
  • •Planned surgery
  • •Suicidality
  • •Severe depression
  • •Ongoing alcohol or substance abuse, and
  • •Ongoing psychosis

研究组 & 干预措施

Unified Protocol

Experimental

CBT based Internet delivered treatment targeting transdiagnostic vulnerability and maintaining factors for chronic pain and emotional problems.

Since this is a new target Group, a replicated single case design was used and participants are their own Control Group (no other treatment arms).

干预措施: Unified Protocol (Behavioral)

结局指标

主要结局

Overall Depression Severity and Impairment Scale (ODSIS)

时间窗: an average of 30 weeks

measures general depression

Overall Anxiety Severity and Impairment Scale (OASIS)

时间窗: an average of 30 weeks

measures general anxiety

The question: How intense has your pain been during the last week?

时间窗: an average of 30 weeks

one item asking for pain during last week (1-10)

次要结局

  • Mini International Neuropsychiatric Interview, MINI(an average of 30 weeks)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matilda Wurm

PhD fellow

Örebro University, Sweden

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