Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorMontefiore Medical Center

About this trial

Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the investigators have designed a prospective randomized clinical trial (2:1) study for 45 Adolescent Idiopathic Scoliosis (AIS) patients, 10-19 years of age. This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome (PRO) measures. The investigators will implement and test a structured perioperative psychological intervention program, based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which was developed based on evidence-based cognitive behavioral therapy (CBT) protocols for the management of pediatric pain and childhood anxiety disorders

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of scoliosis prior to age 20

Healthy, non-obese aged 10-19 years, with a diagnosis of idiopathic scoliosis, undergoing elective posterior spinal fusion

Disqualifiers

Diagnosis of scoliosis after age 20

Permanent cognitive impairment

Pregnant or breastfeeding women

Use of opioids in the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aims to Decrease Anxiety and Pain Treatment (ADAPT)

    Behavioral

    One pre-operative and 3 post-operative sessions of cognitive behavioral therapy (CBT) treatment in the first two months, beginning 2-3 weeks after surgery, will be completed. A HIPAA-compliant mobile application (SMART-MH) may be used as alternative platform to deliver the same ADAPT CBT-based psychoeducation content and allow participants to complete the PRO questionnaires electronically.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: standard of care control groups no psychological interventionNo intervention 0 interventions
Group B: psychological intervention ADAPTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of changes in Anxiety using the Beck Anxiety Inventory (BAI)

Assessment of changes in anxiety, preoperatively to postoperatively, will be assessed using the Beck Anxiety Inventory (BAI). The BAI is a 21-item, self-report tool used to assess anxiety severity over the prior week. Participants are asked to rate their anxiety symptoms using a scale of 0-3 which correlate to "Not at all," "Mildly," "Moderately," or "Severely," respectively. Scores are then totaled yielding an overall range of 0-63. Scores of 0-7 are indicative of low anxiety; 8-15 mild anxiety; 16-25 moderate anxiety; and scores \>=26 are indicative of severe anxiety. Results will be summarized by study arm using basic descriptive statistics.

Time frame
preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group
2

Assessment of changes in Pain Catastrophizing Scale for Children (PCS-C)

Assessment of changes from baseline in catastrophic thinking associated with pain will be assessed using the Pain Catastrophizing Scale for Children (PCS-C), preoperatively and postoperatively. The PCS-C is a 13-item scale. One of the main adaptations of the child version of the pain catastrophizing scale is the repetition of the stem "When I have pain, …" at the beginning of each item. Responses for each statement are provided using a Likert-type rating scale, ranging from 0 (not at all) to 4 (extremely), yielding an overall possible scoring range of 0-52. A higher score on is indicative of a higher level of pain catastrophizing.

Time frame
preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group
3

Assessment of changes in Depression using the Beck Depression Inventory (BDI-II)

Assessment of changes in depression, preoperatively to postoperatively, will be assessed using the Beck Depression Inventory (BDI-II). The BDI-II is a 21-item, self-report tool used to assess depression severity over the prior two weeks. Participants are asked to rate their anxiety symptoms using a scale of 0-3 which correlate to "Not at all," "Mildly," "Moderately," or "Severely," respectively. Scores are then totaled yielding an overall range of 0-63. Scores of 0-13 are indicative of minimal depression; 14-19 mild depression; 20-28 moderate depression; and scores \>=29 are indicative of severe depression. Results will be summarized by study arm using basic descriptive statistics.

Time frame
preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group
4

Assessment of changes in Mental health using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form for Depression

Assessment of changes in Mental health, preoperatively to postoperatively, will be assessed using the PROMIS short form for Depression. This form consists of a set of person-centered measures that evaluate mental health in adults and children. PROMIS measures generate T-scores. T-scores are standard scores with a general population mean of 50 and standard deviation of 10 in a reference sample. PROMIS items consist of a statement (e.g., "I felt alone") with five response options: Never; Rarely; Sometimes; Often; and Always. A PROMIS depression score \<50 is considered normal.

Time frame
preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group

Secondary outcomes

1

Assessment of changes in pain preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis

The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The pain domain has five questionnaires A score \<4 in the SRS-22-r pain domain (1 = severe pain and 5 = pain free) is considered clinically relevant.

Time frame
preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group
2

Sociodemographic factors using Child Opportunity Index (COI)

The Child Opportunity Index (COI) 2.0 measures neighborhood resources and conditions that matter for children's healthy development. Total represents the overall index, while Education represents the education metrics, Health represents the health \& environment metrics, and social \& economic represents the social \& economic metrics. Record sociodemographic factors to assess the impact on treatment adherence and overall outcomes using child opportunity index Child Opportunity Scores are released as metro, state and nationally normed versions. using the nationally normed index conceals within-metro area inequalities because a disproportionate number of neighborhoods are assigned to the "high" and "very high" opportunity levels when referenced to all tracts nationally.

Time frame
preoperatively
3

Assessment of changes in mental health preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis

The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The mental health domain has five questionnaires: 5=Best mental health outcome score1=warning score

Time frame
preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group
4

Assessment of changes in self image score preoperatively and postoperatively using Scoliosis Research Society questionnaire-22 revised (SRS-22r) for adolescents with idiopathic scoliosis

The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The self-image domain has five questionnaires: 5=Best mental health outcome score1=warning score

Time frame
preoperatively (baseline), and postoperatively at 6 weeks, 6 months, and 1 year after surgery for both the standard of care control group and psychological intervention group

Other outcomes

Sponsors and contacts

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Montefiore Medical Center

Lead sponsor

Albert Einstein College of Medicine

Collaborator