Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

NAActive, not recruitingINTERVENTIONAL
Enrollment

433

Participants

Timeline

Start Date

December 29, 2020

Primary Completion Date

January 31, 2025

Study Completion Date

April 30, 2025

Conditions
Juvenile; ScoliosisScoliosis IdiopathicScoliosis; AdolescenceScoliosis;CongenitalKyphosisSpondylolisthesis
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.

Trial Locations (1)

98105

Seattle Children's Hospital, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

University of Utah

OTHER

collaborator

Vanderbilt University

OTHER

collaborator

Johns Hopkins University

OTHER

collaborator

Connecticut Children's Medical Center

OTHER

lead

Seattle Children's Hospital

OTHER

NCT04637802 - Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery | Biotech Hunter | Biotech Hunter