Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention

Study Overview
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Brief Summary
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This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.

Detailed Description
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This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain. Participants will be randomized to one of these two treatments.

Official Title
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Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Interactive - Psychoeducation
* Behavioral: Non-interactive Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: report having low back pain for more than three months and at least half the days in the past 6 months be 18-65 years of age, have scores higher than 37 on the Tampa Scale of Kinesiophobia, Exclusion Criteria: medical conditions other than back pain that significantly impair movement (e.g., arthritis) confirmed/suspected pregnancy pending litigation related to an episode of low back pain significant impairment in vision

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive Psycho-education<br>Interactive psycho-education using interactive dashboard. | Behavioral: Interactive - Psychoeducation<br>* Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.<br>|
| Placebo Comparator: Psycho-education<br>Non-interactive psycho-education not using interactive dashboard. | Behavioral: Non-interactive Psychoeducation<br>* Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity as assessed by Numeric Rating Scale | The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale. 0 = No Pain - 10 = Worst Possible Pain Range of scores: 0-10 | Baseline - Final assessment (average 1 week post treatment) | 
| Present Pain Intensity | Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating) | Baseline - Final assessment (average 1 week post treatment) | 
| Present Pain Rating | Pain Rating Index (PRI) is assessed by 15 questions assessing pain in the sensory and affective dimensions. Items rate from 0 (none) to 3 (severe) on degree to which the words apply to pain. Score Range: 0-45 | Baseline - Final assessment (average 1 week post treatment) | 
| Pain Chronicity assessed by the Graded Chronic Pain Scale | Pain Chronicity is assessed by the Graded Chronic Pain Scale (GCPS). The GCPS is 7 questions with 3 sub-scales (Characteristic pain intensity, disability score, and disability points). Scoring: Characteristic Pain Intensity: is a 0 to 100 score derived from Questions 1 through 3: Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score: is 0 to 100 score derived from Questions 4 through 6: Mean (Daily Activities, Social Activities, Work Activities) X 10 Disability Points: Add the indicated points for Disability Days (Question 7) and for Disability Score (0-6). Items rate from 0 to 10 with 0 referencing no pain/interference/change and 10 referencing pain as bad as could be/unable to carry out any activities/extreme change. | Baseline - Final assessment (average 1 week post treatment) | 
| Daily Pain Monitoring: 10 point scale | Daily pain monitoring defined as daily pain intensity and daily pain interference monitoring is two questions asked daily on a 10 point scale assessing daily pain and how much pain had interfered with day to day activities. Pain: Over the past 24 hours, how would you rate your back pain on average? (0=No Pain; 10=Worst Imaginable Pain) Interference: Over the past 24 hours, how much did pain interfere with your day-to-day activities? (0=No Interference; 10 = A great deal of interference) | Baseline - Final assessment (average 1 week post treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back Disability as assessed by the Roland Morris Disability Questionnaire | The Roland Morris Disability Questionnaire (RMDQ) assesses disability due to low back pain. The RMDQ is a 24 item survey with yes/no response options. Score 0 -24 with ower scores indicate more impairment. | Baseline - Final assessment (average 1 week post treatment) | 
| Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale | The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20 item survey tool. The items are a 4 pt Likert response items. Scores range from 0-60 with higher scores indicate greater levels of depressive symptoms. | Baseline - Final assessment (average 1 week post treatment) | 
| Pain Catastrophizing as assessed by the Pain Catastrophizing Scale | The Pain Catastrophizing Scale (PCS) is a 13 item survey assessing catastrophizing in context to pain. There are 13 items with 5-pt Likert responses. There are several subscales. Scoring Procedure: The PCS total score is computed by summing responses to all 13 items (0-52). Subscales: Rumination: Sum of items 8, 9, 10, 11 (0-16). Magnification: Sum of items 6, 7, 13 (0-12). Helplessness: Sum of items 1, 2, 3, 4, 5, 12 (0-24). | Baseline - Final assessment (average 1 week post treatment) | 
| Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia | The Tampa Scale Kinesiophobia (TSK) is a 17 item assessment of fear of movement. This uses a 5-pt Likert scale from 1 = Strongly Disagree to 4 = Strongly Agree. Scoring Procedure: Sum items Range: 17-68 Subscale Harm/Somatic Items: 3, 5, 6, 9, 11, 15 Subscale Avoidance Items: 1, 2, 7, 10, 13, 14, 17 | Baseline - Final assessment (average 1 week post treatment) | 
| Mood and Affect as assessed by the Positive and Negative Affect Scale | The Positive and Negative Affect Scale (PANAS) measures mood of participants. This is a 20 item survey with 5 pt Likert response indicating to what degree the participant feels those emotions. There is a positive and negative subscale. Higher positive affect score indicates greater positive emotions; higher negative affect score indicates greater negative emotions. Range of Scores: 0-40 | Baseline - Final assessment (average 1 week post treatment) | 
| Immersive Tendencies | Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire (ITQ). This is an 18-item survey. Item responses use a 7 point Likert scale. Subscales include: focus, involvement, emotions, and play. Each subscale is scored by summing items. A total score is scored by summing all items. Range of total score: 18-126 Focus range of scores: 5-35 Involvement range of scores: 5-35 Emotions range of scores: 4-28 Play range of scores: 3-21 Higher scores indicate higher immersive tendencies overall and in each sub-scale. | Baseline only | 
| Absorption Tendencies | Tellegen Absorption Scale is a 34-item multi-dimensional measure that assesses imaginative involvement and the tendency to become mentally absorbed in everyday activities. Item responses are on a 5-point Likert scale. Items are summed to score. Range of scores: 0-136. Higher scores indicate greater levels of absorption. | Baseline Only | 
| Video Game History | History of playing video games. | Baseline Only | 
| Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory | Patient treatment evaluation is assessed by Treatment Evaluation Inventory. This is a 9 item scale with a 5-point Likert responses for each question. The items are scored by summing all items. Range of scores: 9-45. A higher score indicates greater acceptance of treatment. | Final assessment (average 1 week post treatment) | 
| Patient Treatment Evaluation as assessed by Semi-structured Qualitative interviewing | Patient treatment evaluation is assessed by semi-structured interviewing. Qualitative feedback from participant experience will be assessed by thematic analyses. | Final assessment (average 1 week post treatment) | 
| Daily intervention feedback questions | The daily intervention feedback questions are 7 items that assess the individuals feelings and experiences during that daily intervention session. 0-10 Likert scale Each item is it's own scale. Higher scores indicate more enjoyment/usefulness/demand/awareness/concern/mood. | Baseline - Final assessment (average 1 week post treatment) | 
| Patient Treatment Evaluation as assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire | The Usefulness, Satisfaction, and Ease of Use Questionnaire (USE, Lund, 2001) measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. This metric can be applied to various scenarios of usability assessment because it is non-proprietary and technology-agnostic. is a 30 item survey. Each item is presented on a 7-point Likert scale from strongly disagree = 1 to strongly agree. = 7 Each subscale is calculated by averaging all items in subscale. Usefulness: items 1-8 Ease of use: items 9-19 Ease of Learning: items 20-23 Satisfaction: items 24-30 Range of scores for each subscale: 1-7 Scoring Interpretation: Higher score indicates greater usefulness, satisfaction, and ease of use. | Final assessment (average 1 week post treatment) | 
| Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale | Patient treatment evaluation is assessed by the Patient Global Impression of Change. This is a one item 7 point Likert item assessing improvement of the participants overall status. Item responses: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse | Final assessment (average 1 week post treatment) | 
| Video Game Preferences as assessed by the BrainHex | Video game preferences will be assessed by the BrainHex. The BrainHex provides a tool for designing gameplay and understanding motivations for play. | Final assessment (average 1 week post treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Low Back Pain