Personalising Cognitive Behaviour Therapy for Chronic Primary Pain Using Network Analysis - A Single Case Experimental Design Study With Multiple Baselines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ecological Momentary Assessment questionnaire
研究概览
简要总结
The goal of this single case experimental design study with multiple baselines is to use network analysis to personalise cognitive behaviour therapy for chronic primary pain (CPP) and base the selection of individual treatment targets and interventions on data to avoid cognitive biases of the clinicians. The main questions it aims to answer are:
- Is the study procedure accepted by and feasible for CPP patients as well as their therapists?
- Does the personalised psychotherapy with databased clinical decisionmaking lead to significant improvement?
Participants will go through several study phases:
- Pretest and informational meeting with study management
- Baseline 1: answering a questionnaire six times a day for 21 days in daily life on their mobilephone (EMA); this data will be used for the calculation of a network for each participant, that in turn will be used to select the treatment target and according treatment intervention as suggested by an algorithmic decisiontool
- Probatory therapy phase: three weekly sessions with therapist; questionnaire three times a week
- Baseline 2: questionnaire three times a week
- Therapy phase: up to ten sessions with therapist; questionnaire three times a week
- Post phase: posttest, two weeks of three weekly assessments, then another 21 days EMA; two monthly booster sessions with therapist
- Follow-up: posttest and meeting with study management
详细描述
Background and aims:
The treatment of chronic primary pain (CPP) with Cognitive Behaviour Therapy (CBT) is effective, yet effects remain small to moderate. New approaches to the treatment of CPP are needed. They should include an orientation toward processes instead of symptoms and strategies for personalisation. This paradigm shift requests precisce, testable models that allow to link treatment procedures to psychological changes. Unfortunately, current models are rather vague about specific, especially temporal pathways by which its elements interact, or the pathways are not as simplistic as proposed. Therefore, multiple variables and pathways related to the development and persistence of pain-related disabilities should be considered.
One approach to individualisation makes use of repeated measures in the daily lives of patients, which enable the usage of network analysis to investigate interactions between symptoms/processes of a patient. Process-oriented, individualised, network-based therapy for CPP (POINT Pain) combines process-oriented measurements to individualise therapy with network-based analysis approaches for target and treatment selection. We propose the following hypotheses:
- In line with previous research, we assume that the implementation of POINT Pain is feasible for and accepted by patients as well as therapists. Feasibility and acceptance are indicated by mean ratings of at least 3.5 out of 5 across all items of one scale (each rated on 1-5 Likert scales) on a feedback form developed for this study and by positive comments to open ended questions.
- Furthermore, we expect POINT Pain to lead to clinically significant improvements as compared to baseline, i.e. decreasing scores in the outcome measures. According to current recommendations, the improvement will be operationalised as effect-size estimated with Hedge's g, the significance with Tau-z.
Procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •main diagnosis of chronic pain (i.e. pain persists for at least 6 months and is the most prominent/most burdensome symptom)
- •subjective impairment/disability (yes-no)
- •access to a smartphone compatible with the app mPath
排除标准
- •acute hazard due to suicidality, substance abuse, and/or psychosis
- •only migraine/headache or migraine/headache are the focus of pain
- •analphabetism
- •insufficient German knowledge
- •current psychotherapy
- •current participation in another intervention study
- •physical inability to take part in therapy and study sessions
结局指标
主要结局
Ecological Momentary Assessment questionnaire
时间窗: pre-intervention (two baselines), during intervention (on average 10 weeks + 3 weeks probatory phase), directly after intervention (2 weeks + 21 days)
Throughout the whole study, the same questionnaire developed and in-evaluation for the use in Ecological Momentary Assessment will be applied. It assesses several therapy-relevant pain processes derived from common psychological models of chronic pain: catastrophising, avoidance, depression (Fear-Avoidance model, Avoidance-Endurance model); thought supression, task persistence, positive affect (Avoidance-Endurance model); acceptance, values (Psychological Flexibility); expectations (Predictive Coding); pain instenisty, pain-related disability (Pain Experience); pain self-efficacy, sleep disturbance, self-compassion. The individual primary outcome will be the most relevant process for each participant according to the network from the first baseline.
Pain Disability Index (PDI)
时间窗: Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)
The Pain Disability Index assesses the daily disability caused by pain in seven areas: family/domestic duties, recovery, social activities, work, sexuality, self-care, and life-sustaining activities. It has shown to be a valid instrument, displaying moderate test-retest reliability.
Quebec Back Pain Disability Scale (QBPDS)
时间窗: Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)
The Quebec Back Pain Disability Scale will be adapted for chronic pain in general in this study. It assesses disability caused by pain in 20 activities relevant to everyday life. It displays sufficient validity and reliability.
次要结局
- German Pain Solutions Questionnaire (PaSol)(Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention))
- Pain Intensity(Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention))
- Short-Form McGill Pain Questionnaire (SF-MPQ)(Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention))
- Patient Global Impression of Change (PGIC)(Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention))
- Pain Self-Efficacy Questionnaire(Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention))
- Acceptance and feasibility of study procedures (Feedback form developed for this study)(Post-intervention (directly after intervention), Follow-up (on average three months after intervention))
研究者
Prof. Dr. Julia Glombiewski
Clinical professor, Head of department clinical psychology and psychotherapy for adults
University of Kaiserslautern-Landau