Clinical Trial Finder

Inclusion Criteria:

Teen.

• - 12 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.

Exclusion Criteria:

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)

Major musculoskeletal surgeries are associated with particularly high prevalence of both acute and chronic post-surgical pain (CPSP), with 80% of youth reporting intense acute pain after hospital discharge, and up to half reporting CPSP up to one year after spine surgery. Interventions to improve recovery and reduce pain after surgery have potential to interrupt a negative trajectory of suffering and disability associated with chronic pain. Our specific aims are: Primary:

• (1) Determine effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, (2) Determine effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, (3) Determine the combined effects of pre- and post-operative psychosocial intervention on chronic pain outcomes.

Secondary:

• (1) Determine effectiveness of pre-operative psychosocial intervention to reduce opioid use during the 14 days following hospital discharge, (2) Determine effectiveness of psychosocial intervention to improve health-related quality of life following surgery.

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.

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.

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.

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

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

Interventions

Behavioral: - CBT (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.

Behavioral: - Education

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.