Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

Browse trials for

• Scoliosis 660
• Kyphosis 132
• Spondylolisthesis 227
• Chronic Pain 3,227
• Acute Pain 1,073

Keywords

• Psychosocial Intervention
• Spinal Fusion Surgery
• Chronic Pain
• Acute Pain
• Adolescent
• Randomized controlled trial

Scoliosis

660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.

This study's enrollment of 433 is above the median of 45 across 386 interventional studies indexed under Scoliosis.

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.

Study arms

• Active comparator
  Pre-operative and Post-operative Education intervention

  This arm receives access to Patient Education intervention in the pre- and post-operative phases.

  Behavioral: Education

• Experimental
  Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention

  This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.

  Behavioral: CBT (SurgeryPal) · Behavioral: Education

• Experimental
  Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)

  This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.

  Behavioral: CBT (SurgeryPal) · Behavioral: Education

• Experimental
  Pre-operative and Post-operative CBT intervention (SurgeryPal)

  This arm receives access to CBT intervention during the pre-operative and post-operative period.

  Behavioral: CBT (SurgeryPal)

Interventions

• BehavioralCBT (SurgeryPal)

  The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.

• BehavioralEducation

  The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.

Primary outcomes

1. Post-surgical Pain Severity and Interference

   The Brief Pain Inventory (BPI) has 2 scales: pain severity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain severity or interference (worse). The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-discharge (beginning on day 1 after hospital discharge, and ending on day 14, up to a maximum of 3-weeks post-surgery). Daily scores from days 1-14 post-hospital-discharge were averaged for each participant, and mean values across all participants are reported here.

   Time frame: 1-14 days post-hospital-discharge, up to 3 weeks post-surgery (T2)

2. Chronic Pain Severity and Interference

   The Brief Pain Inventory (BPI) has 2 scales: pain severity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain severity or interference (worse). The 24 hour (short) version of this measure will be completed via REDCap daily for 7 days at 3 months after the participant's surgery date. Daily scores across the 7 days were averaged for each participant, and mean values across all participants are reported here.

   Time frame: 3 months post-surgery (T3)

Secondary outcomes

1. Change in Health-related Quality of Life

   The Pediatric Quality of Life Inventory (Peds-QL) 15-item short form assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used and demonstrates good reliability for both the parent and child self-report measures. Scale scores (all scales, including both total and subscales) range from 0 to 100. Higher scores indicate fewer difficulties (better) health-related quality of life. Subscales of physical and psychosocial health will be used in analyses.

   Time frame: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

2. Change in Opioid Use

   Youth will report medication use on the Brief Pain Inventory (BPI), including selecting medication name from a dropdown list (opioid, acetaminophen, anti-inflammatory, other). Number of days of opioid use will be used in analyses.

   Time frame: Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)

3. Change in Opioid Misuse

   The American Psychiatric Association (APA) Adapted National Institute for Drug Abuse (NIDA) Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Level 2 Tool (Teen Report) recommended by the National Institute on Drug Abuse for substance use screening in adolescents, will be used to assess opioid misuse. Additional questions on reasons for misuse (e.g. to treat pain, to get high, etc.) and source of opioids (e.g. prescription, from a friend or relative) will be collected using the corresponding questions and response options used in the National Survey on Drug Use and Health. For analysis, we will report the percentage of participants that endorsed any opioid misuse at each assessment.

   Time frame: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

4. Change in Psychosocial Distress

   The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms that evaluates negative mood, view of self and social cognitions. Response options range from 1 (Never) to 5 (Almost Always). Raw scores for anxiety and depression are obtained by summing the corresponding items' response values, and range from 8 to 40 with higher scores indicating higher distress. Raw scores and T-scores are computed with higher T-scores above 60 indicating clinically elevated (worse) symptoms. The general population mean T-score is 50, with a standard deviation of 10. Anxiety T-scores range from 33.5-83.3, and depression T-scores range from 35.2-82.4. T-scores are reported here.

   Time frame: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

5. Change in Mental Health

   Parents and teens will self-report on the Patient Health Questionnaire-4, a 4 item screening measure of general anxiety and depressive symptoms. Response options range from 0 (Not at all) to 3 (Nearly Every Day). Total scores are calculated by summing items, for a total score ranging from 0 to 12, with higher scores indicating greater anxiety and depressive symptoms (poorer outcome).

   Time frame: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

6. Change in Sleep Quality

   The Adolescent Sleep Wake Scale 10-item version (Teen Report) is a 10-item measure that assesses self-reported sleep quality. Scale scores (including both individual/subscale and total scores) range from 1 to 6 with higher scores indicating better sleep quality. The total score reported here is the average of all subscale scores.

   Time frame: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

7. Change in Pain Catastrophizing

   The Pain Catastrophizing Scale - Child Version and Parent Version is a Self-report 13 item measures that assess child pain catastrophizing and parent's catastrophizing about child's pain, respectively. Total scores range from 0 to 52 with higher scores indicating greater pain catastrophizing (worse).

   Time frame: Baseline (T1), 3-months post-surgery (T3)

8. Global Pain Severity

   The Patient Global Impression of Severity Scale (PGIS), Teen Report is a 1-item measure that assesses adolescent's self-reported global impression of pain severity. Response options range from 0 (none) to 3 (severe) with higher scores indicating higher pain severity (worse).

   Time frame: Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)

Baseline characteristics

Publications

• Rabbitts JA, Zhou C, de la Vega R, Aalfs H, Murray CB, Palermo TM. A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial. Trials. 2021 Jul 30;22(1):506. doi: 10.1186/s13063-021-05421-3. PubMed 34330321 ↗

Study documents

• Study protocol ↗ · Oct 17, 2023
• Statistical analysis plan ↗ · Jun 28, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — A releasable database for underlying primary data for publications will be made broadly available on the NIH HEAL Initiative central data repository. The database will be produced and will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. In accordance with policies of the NIH, the DCC will send the releasable database to the entity determined by the NIH or specific institute to be the repository for data created under the HEAL initiative. The DCC is able to produce a relational database export, or use SAS or SPSS data sets. The DCC will accompany the database with full documentation so that individual investigators will be able to effectively use the data.

Time frame: After last subject enrollment and all follow up procedures have been completed, the HEAL Pain Management Effectiveness Research Network Data Coordinating Center (DCC) at the University of Utah will prepare a final study database for the trial, which will then be used for statistical analyses and publication of findings from the trial. The policies for release of this database are in accordance with the HEAL Data Sharing policy as determined by the NIH. Our preliminary plan is to release the underlying primary database at the time of publication of the primary manuscript. The primary publication from the dataset will be made publicly available immediately without any embargo period through the Creative Commons Generic License in accordance with the HEAL Public Access guidance. Additional secondary publications will be deposited electronically within 4 weeks of acceptance into PubMed Central.

Access criteria: Access to the releasable database housed in the NIH-assigned repository will be in accordance with procedures and regulations of the NIH or specific institute. The DCC will not provide any support for investigators using the releasable database.