Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention (VRGE)
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|ClinicalTrials.gov Identifier: NCT03909048|
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Behavioral: Interactive - Psychoeducation Behavioral: Non-interactive Psychoeducation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participant, statistician, and outcomes assessor are blinded.|
|Official Title:||Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Interactive Psycho-education
Interactive psycho-education using interactive dashboard.
Behavioral: Interactive - Psychoeducation
Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.
Placebo Comparator: Psycho-education
Non-interactive psycho-education not using interactive dashboard.
Behavioral: Non-interactive Psychoeducation
Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.
- Pain Intensity as assessed by Numeric Rating Scale [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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
- Present Pain Intensity [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating)
- Present Pain Rating [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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
- Pain Chronicity assessed by the Graded Chronic Pain Scale [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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).
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.
- Daily Pain Monitoring: 10 point scale [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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)"
- Back Disability as assessed by the Roland Morris Disability Questionnaire [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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.
- Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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.
- Pain Catastrophizing as assessed by the Pain Catastrophizing Scale [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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).
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).
- Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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
- Mood and Affect as assessed by the Positive and Negative Affect Scale [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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
- Immersive Tendencies [ Time Frame: Baseline only ]
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.
- Absorption Tendencies [ Time Frame: Baseline Only ]
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.
- Video Game History [ Time Frame: Baseline Only ]History of playing video games.
- Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory [ Time Frame: Final assessment (average 1 week post treatment) ]
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.
- Patient Treatment Evaluation as assessed by Semi-structured Qualitative interviewing [ Time Frame: Final assessment (average 1 week post treatment) ]Patient treatment evaluation is assessed by semi-structured interviewing. Qualitative feedback from participant experience will be assessed by thematic analyses.
- Daily intervention feedback questions [ Time Frame: Baseline - Final assessment (average 1 week post treatment) ]
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.
- Patient Treatment Evaluation as assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire [ Time Frame: Final assessment (average 1 week post treatment) ]
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.
- Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale [ Time Frame: Final assessment (average 1 week post treatment) ]
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.
1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse
- Video Game Preferences as assessed by the BrainHex [ Time Frame: Final assessment (average 1 week post treatment) ]Video game preferences will be assessed by the BrainHex. The BrainHex provides a tool for designing gameplay and understanding motivations for play.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909048
|Contact: Zina Trost, PhDemail@example.com|
|Contact: Deanan Rumble, PhDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Zina Trost, PhD 205-975-6936 email@example.com|
|Contact: Deanna Rumble, PhD 2059349040 firstname.lastname@example.org|
|Principal Investigator: Zina Trost, Ph.D.|