Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

NCT04637802 | Completed DMC

• 1 other identifier: UH3HD102038
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).

Conditions

Juvenile; Scoliosis; Scoliosis Idiopathic; Scoliosis; Adolescence; Scoliosis;Congenital; Kyphosis; Spondylolisthesis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Post-surgical pain intensity and interference

  The Brief Pain Inventory (BPI) has 2 scales: pain intensity (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 intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-hospital discharge (beginning on day 1 after hospital discharge, and ending up to 3-weeks post-surgery).

  Up to 3 weeks post-surgery

• Chronic pain intensity and interference

  The Brief Pain Inventory (BPI) has 2 scales: pain intensity (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 intensity or interference. 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.

  3 months post-surgery

Secondary Outcomes (8)

• Change in health-related quality of life

  Baseline, 3-months post-surgery, 6-months post-surgery

• Change in opioid use

  Baseline, Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery

• Change in opioid misuse

  Baseline, 3-months post-surgery, 6-months post-surgery

• Change in psychosocial distress

  Baseline, 3-months post-surgery, 6-months post-surgery

• Change in mental health

  Baseline, 3-months post-surgery, 6-months post-surgery

Study Arms (4)

Pre-operative and Post-operative Education intervention

ACTIVE COMPARATOR

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

Behavioral: Education

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Behavioral: CBT (SurgeryPal)

Interventions

CBT (SurgeryPal) BEHAVIORAL

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.

Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention; Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal); Pre-operative and Post-operative CBT intervention (SurgeryPal)

Education BEHAVIORAL

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.

Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention; Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal); Pre-operative and Post-operative Education intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Teen
• to 18 years old at the time of enrollment
• Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis)
• Parent/Caregiver
• Parent or legal guardian of child who meets study criteria

You may not qualify if:

• Teen
• Does not speak or understand English
• Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level)
• Does not have access to a smart device (smartphone, iPad or tablet; Teens can borrow an iPad from the study team if one is available)
• Recent psychiatric admission (in the past 30 days)
• Severe systemic disease (neuromuscular scoliosis, cancer)
• On a regular treatment regimen for a severe chronic medical condition
• Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery)
• Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain)
• Parent/Caregiver
• Does not speak or understand English
• Does not have access to a smart device (smartphone, iPad or tablet)

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Duke University: collaborator
• University of Utah: collaborator
• Vanderbilt University: collaborator
• Johns Hopkins University: collaborator
• Connecticut Children's Medical Center: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 34330321 DERIVED

MeSH Terms

Conditions

Scoliosis; Kyphosis; Spondylolisthesis; Chronic Pain; Acute Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jennifer Rabbitts, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Tonya Palermo, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist

Model Details: Randomized and double-blinded controlled trial of cognitive-behavioral intervention vs education at two phases (pre-operative and post-operative)

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 20, 2020
• Study Start: December 29, 2020
• Primary Completion: December 5, 2024
• Study Completion: March 12, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)