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临床试验/NCT05079984
NCT05079984已完成不适用

Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

Stanford University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年5月2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
108
试验地点
2
主要终点
Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Likert Scale (Aim 1 and Aim 2)

研究概览

简要总结

This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level.

Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in one session (lasting 2 hours).

In Aim 2, Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.

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
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Youth ages 10-18
  • Have diagnosis of chronic musculoskeletal pain (>3months)
  • Have moderate to high pain interference (PROMIS Pain Interference ≥ 61)
  • English literate
  • Have access to computer, smartphone, or tablet with internet connection

排除标准

  • Significant cognitive impairment (e.g., brain injury)
  • Significant medical or psychiatric problems that would interfere with treatment

研究组 & 干预措施

Graded Exposure Intervention

Experimental

For Aim 2, adolescents with chronic pain will be enrolled in a single-arm feasibility trial examining acceptability, feasibility, and preliminary effectiveness of a novel, digitally delivered, graded exposure treatment.

干预措施: Graded exposure treatment (GET) (Behavioral)

User centered development

No Intervention

For Aim 1, participants engaged with the prototypes of the intervention and provided feedback.

结局指标

主要结局

Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Likert Scale (Aim 1 and Aim 2)

时间窗: Baseline through 3-month follow-up (up to 22 weeks)

Participant-rated acceptability measured on 5-point Likert scale. Range 0-4 (higher scores indicate more acceptable). Questionnaire will be administered to youth with chronic pain and their parents.

Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Participant Responses (Aim 1 and Aim 2)

时间窗: Baseline through 3-month follow-up (up to 22 weeks)

Acceptability will be assessed qualitatively through participant responses to open-ended questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Responses will be assessed categorically by the investigator. Questionnaire will be administered to youth with chronic pain and their parents.

Participant Satisfaction with the Intervention (Aim 1 and Aim 2)

时间窗: 19 weeks (Assessed at the end of treatment)

Treatment satisfaction at the end of treatment will be evaluated by examining mean satisfaction scores on an adapted version of the Pain Service Satisfaction Test (PSST, McCracken et al., 1997). The PSST consists of 23 items rated on a 5-point Likert Scale (0 = not at all satisfied to 4 = very satisfied) and assesses the patient and parent's experience of the intervention. Scores range from 0-92. A score greater than/equal to 40 of 60 (satisfied to very satisfied) will indicate high levels of satisfaction with the intervention content.

Percentage of Participants Dropped Out of Intervention (Aim 2)

时间窗: 19 weeks (Assessed at the end of treatment)

As a measure of treatment adherence, we will calculate the percentage of participants who drop out or withdraw from the intervention prior to completion of the intervention.

Expectations for Treatment (Aim 2)

时间窗: Baseline (up to 2 minutes to complete the survey)

Participants (child) and parent expectations for treatment will be measured by the Treatment Expectancy and Creditability, Borkovec \& Nau, 1972). The TEC is comprised of 6 items rated on a 0 to 10 Likert-scale assessing expectations related to the effectiveness of the current treatment. The TEC is completed by the patient at the end of the first treatment session. Higher scores indicate greater expectations for treatment effectiveness.

Functional Disability (Aim 2)

时间窗: Baseline through 3-month follow-up (up to 22 weeks)

Functional disability will be assessed using the Functional Disability Inventory (FDI, Walker \& Greene, 1991), a 15-item self-report measure of perceived difficulty in performing activities in school, home, physical, and social contexts. Items are rated on a 5-point Likert scale ranging from 0 (no trouble) to 4 (impossible). Items are summed to create a total score (range 0-60), with higher scores indicating greater disability.

Assessment of Acceptability of Treatment Content - Likert Scale (Aim 1)

时间窗: One day

Participant-rated acceptability measured on 5-point Likert scale. Range 0-4 (higher scores indicate more acceptable). Questionnaire will be administered to youth with chronic pain and their parents.

Participant Satisfaction With the Intervention (Aim 2)

时间窗: 10 weeks (assessed at discharge)

Treatment satisfaction at the end of treatment will be evaluated by examining mean satisfaction scores on an adapted version of the Pain Service Satisfaction Test (PSST, McCracken et al., 1997). The PSST consists of 23 items rated on a 5-point Likert Scale (0 = not at all satisfied to 4 = very satisfied) and assesses the patient and parent's experience of the intervention. Scores range from 0-92. A score greater than/equal to 40 of 60 (satisfied to very satisfied) will indicate high levels of satisfaction with the intervention content. Caregivers were not assessed for this Outcome Measure.

Percentage of Participants Dropped Out of Intervention (Aim 2)

时间窗: 10 weeks (Completed at discharge)

As a measure of treatment adherence, we will calculate the percentage of participants who drop out or withdraw from the intervention prior to completion of the intervention.

Expectations for Treatment (Aim 2)

时间窗: Assessed seven days after starting the intervention (7 days post-baseline)

To assess expectations for treatment effectiveness, participants completed the Credibility/Effectiveness Questionnaire (CEQ; Borkovec \& Nau, 1972) after engaging with iGET Living for one week. The CEQ consists of six items rated on a 0 (not at all) to 10 (very much) Likert scale and assesses expectations related to the effects of the intervention across two subscales: Credibility (e.g., "How confident would you be recommending iGET Living to a friend with the same problems?") and Expectancy (e.g., "By the end of iGET Living, how much do you think your functioning will improve?"). Credibility is calculated by summing items 1-3 and Expectancy by summing items 4-6. Possible range of scores for each subscale is 0-30, with higher scores reflecting greater perceived credibility and expectancy.

Functional Disability (Aim 2)

时间窗: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)

Functional disability will be assessed using the Functional Disability Inventory (FDI, Walker \& Greene, 1991), a 15-item self-report measure of perceived difficulty in performing activities in school, home, physical, and social contexts. Items are rated on a 5-point Likert scale ranging from 0 (no trouble) to 4 (impossible). Scores from all the Items are summed to create a total score (range 0-60), with higher scores indicating greater disability.

次要结局

  • Parental Fear of Pain (Aim 2)(Baseline through 3-month follow-up (up to 22 weeks))
  • Child Fear of Pain (Aim 2)(Baseline through 3-month follow-up (up to 22 weeks))
  • Parent Pain Catastrophizing (Aim 2)(Baseline through 3-month follow-up (up to 22 weeks))
  • Parent Psychological Flexibility (Aim 2)(Baseline through 3-month follow-up (up to 22 weeks))
  • Child Pain Catastrophizing (Aim 2)(Baseline through 3-month follow-up (up to 22 weeks))
  • Child Pain Acceptance (Aim 2)(Baseline through 3-month follow-up (up to 22 weeks))
  • Parent Responses to Childs Pain (Aim 2)(Baseline through 3-month follow-up (up to 22 weeks))
  • Child Fear of Pain (Aim 2)(Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge))
  • Parental Fear of Pain (Aim 2)(Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge))
  • Child Pain Catastrophizing (Aim 2)(Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge))
  • Parent Pain Catastrophizing (Aim 2)(Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge))
  • Child Pain Acceptance (Aim 2)(Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge))
  • Parent Psychological Flexibility (Aim 2)(Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge))
  • Parent Responses to Childs Pain (Aim 2)(Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge))

研究者

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

Lauren Harrison

Clinical Assistant Professor

Stanford University

研究点 (2)

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