Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Pain severity
研究概览
简要总结
The goal of this clinical trial is to examine the efficacy of cognitive bias modification for interpretation (CBM-I) in people with Type 2 Diabetes and persistent pain. The main question[s] it aims to answer is whether interpretation bias training away from pain improves pain outcomes.
Participants in the CBM-I group will complete 4 online training sessions approximately half an hour each. Each session will present participants with ambiguous scenarios which may be pain-related, however the final word of the sentence will resolve the scenario as benign (thus training participants to make benign interpretations). A measure of interpretation bias will be administered following the fourth training session, and pain severity and interference will be measured at baseline, post-training, two week follow up, and three month follow up.
The study hypothesises that participants in the CBM-I group will demonstrate a greater reduction in the co-primary outcomes of pain severity and pain interference over time compared to those in the placebo control.
详细描述
Pre-intervention stage The study will employ a dual consent process. First, participants will complete an "expression of interest" survey which contains the eligibility survey. Given it is crucial for the study to include people with diabetes and persistent pain, this eligibility survey will be used to ensure the sample meets our eligibility criteria of being 1) are over 18 years of age; 2) have been diagnosed with type 2 diabetes; 3) have persistent pain; 4) score ≥ 3 on pain severity subscale on BPI; 5) fluent in English; 6) have access to internet and ability to use a computer over three months.
Participants deemed eligible for the study will be provided with the Participant Information Statement and consent form via Qualtrics, which will provide detailed information about the study, the nature of their participation, and their rights as participants, including the right to withdraw at any point. Participants who do not consent to participate will be redirected to the end-of-survey.
After providing consent, participants will be asked to complete the baseline questionnaires: Brief Pain Inventory (BPI), Depression, Anxiety and Stress Scale (DASS-21), 12-Item Short Form Survey (SF-12), the Worries about Recurrence or Progression Scale (WARPS) and the Treatment adherence perception (TAPQ). The rationale of these measures is that they are theoretically related to interpretation biases and are hypothesised to change following training. This is expected to take approximately 15-20 minutes of their time.
Intervention stage Immediately following completion of baseline questionaries, participants will be randomised to either the CBM-I or placebo groups automatically using a computer algorithm in Qualtrics and invited to participate in the first session (training session 1) (day 1). Neither the participants nor the researchers will be aware of which group the participant has been allocated to.
Three days after completion of the first training session (day 4), participants will be invited via email automated by Qualtrics to the next training session (training session 2). On day 7, participants will be invited to the next training session (training session 3). Each training session is expected to take 10-15 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Over 18 years of age
- •Have a diagnosis of Type 2 diabetes.
- •Have persistent pain (pain present on more days than not, for 3 months or longer).
- •Score ≥ 3 on average pain severity on the Brief Pain Inventory (BPI).
- •Fluent in English
- •Have access to internet and ability to use a computer over a three month period.
排除标准
- •Under 18 years of age
- •No diagnosis of Type 2 diabetes
- •No persistent pain
- •Not fluent in English
- •No access to internet nor ability to use a computer.
研究组 & 干预措施
Cognitive Bias Modification for Interpretation
The Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. All scenarios in this arm are resolved to be benign.
干预措施: Cognitive Bias Modification for Interpretation (Behavioral)
Placebo Cognitive Bias Modification for Interpretation
The placebo Ambiguous Scenarios paradigm is administered remotely online. The intervention is administered four times: at day 1, day 4, day 7, and day 14. Each intervention presents 30 ambiguous scenarios and associated comprehension questions, and should take approximately 20 minutes to complete. Scenarios are resolved as either benign or pain-related, with equal numbers (15) of each per session.
干预措施: Placebo (Behavioral)
结局指标
主要结局
Pain severity
时间窗: Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
Intensity subscale of the Brief Pain Inventory (range 0 - 40; lower scores represent less pain severity, i.e. better outcome)
Pain interference
时间窗: Baseline, post intervention (day 14), Pre intervention session 2 (day 4), pre intervention session 3 (day 7) [primary timepoint], two week follow up post intervention (day 28) [primary timepoint], three month post intervention follow up (3 months)
Interference subscale of the Brief Pain Inventory (range 0 - 70; lower scores represent less pain interference, i.e. better outcome)
次要结局
- Interpretation bias to pain (1)(Post intervention (day 14))
- Interpretation bias to pain (2)(Post intervention (day 14))
- Health-related quality of life(Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104))
- Depression(Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104))
- Anxiety(Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104))
- Stress(Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104))
- Fear of disease progression(Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104))
- Treatment Adherence(Baseline, post intervention (day 14), 2 week follow up (day 28), 3 month follow up (day 104))