Cognitive Behavioral Therapy for Scoliosis

(PASS Trial)

Recruiting at 1 trial location

Overseen By Eric Fornari, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Opioids

Disqualifiers: Cognitive impairment, Pregnancy, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a psychological program called ADAPT (Aim to Decrease Anxiety and Pain Treatment) can reduce anxiety and pain in children and teens with scoliosis undergoing back surgery. The ADAPT program uses cognitive behavioral therapy to improve thoughts and feelings about pain and anxiety. Participants will either try the ADAPT program or continue with regular care to compare results. This trial suits children and teens aged 10-19 with scoliosis who plan to have spinal fusion surgery and do not have other major health issues. As an unphased trial, it offers a unique opportunity to explore new ways to manage anxiety and pain before surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids in the last 6 months.

What prior data suggests that this protocol is safe for adolescents with scoliosis?

Research shows that the Aim to Decrease Anxiety and Pain Treatment (ADAPT) could help manage anxiety and pain in young patients. Studies have found that addressing both anxiety and pain can improve outcomes for children with functional abdominal pain disorders (FAPD), suggesting the ADAPT approach might be beneficial.

In a study on children undergoing scoliosis surgery, the treatment aimed to reduce pain and aid recovery for up to six weeks post-surgery. Although specific safety details for ADAPT in these cases aren't provided, the focus on mental support suggests a low risk of side effects.

Overall, ADAPT appears well-tolerated. It employs cognitive behavioral therapy techniques, which are generally safe and commonly used to manage anxiety and pain in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cognitive behavioral therapy approach for scoliosis because it aims to tackle the anxiety and pain associated with the condition through a psychological intervention model called ADAPT (Aim to Decrease Anxiety and Pain Treatment). Unlike traditional scoliosis treatments, which often focus on physical interventions like bracing or surgery, ADAPT emphasizes mental health, providing a holistic way to manage symptoms. This approach could offer a non-invasive, drug-free method to improve patients' quality of life by addressing both the psychological and physical challenges of scoliosis.

What evidence suggests that the ADAPT protocol is effective for managing anxiety and pain in AIS patients?

Research shows that cognitive behavioral therapy (CBT) can help manage pain and anxiety in teenagers with scoliosis. In this trial, participants will receive either the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model, a psychological intervention based on CBT, or standard care without psychological intervention. Studies have found that programs like the ADAPT model are practical and well-liked by these teens. These programs have successfully managed anxiety and pain related to scoliosis. Specifically, they lower anxiety and improve coping skills during tough times, such as surgery. Using CBT in this way might enhance both physical and mental well-being. ^{1 5 6 7 8}

Who Is on the Research Team?

Eric D Fornari, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy, non-obese young people aged 12-19 with a diagnosis of idiopathic scoliosis who are about to have elective posterior spinal fusion surgery. They should be diagnosed before age 20 and will undergo mental health, pain, and function assessments.

Inclusion Criteria

I am a healthy, non-obese 10-19 year old with idiopathic scoliosis, planning to have spinal fusion surgery.

I was diagnosed with scoliosis before I turned 20.

Exclusion Criteria

I was diagnosed with scoliosis as an adult.

Pregnant or breastfeeding women

I have a history of liver or kidney diseases and developmental delays.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of mental health, pain, and function in AIS patients using validated patient-reported outcome measures

1 week

Perioperative Psychological Intervention

Implementation and testing of a structured perioperative psychological intervention program based on the ADAPT model

6 weeks

Weekly sessions (in-person or virtual)

Postoperative Follow-up

Assessment of changes in mental health, anxiety, and pain using various scales at multiple time points post-surgery

1 year

Visits at 6 weeks, 6 months, and 1 year post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Aim to Decrease Anxiety and Pain Treatment (ADAPT)

Trial Overview The study tests the ADAPT program—a psychological intervention based on cognitive behavioral therapy—to see if it can reduce anxiety and pain in patients undergoing scoliosis surgery. Participants are randomly assigned to receive this intervention or not.

How Is the Trial Designed?

Group I: psychological intervention ADAPT Experimental Treatment 1 Intervention

The psychological intervention plan is based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT) model.

Group II: standard of care control groups no psychological intervention Active Control 1 Intervention

standard of care control groups no psychological intervention

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Published Research Related to This Trial

Psychosocial interventions for adolescents with idiopathic scoliosis have been found to be feasible and acceptable, showing significant positive effects on various outcomes such as postoperative pain, social engagement, brace compliance, coping abilities, and anxiety, based on a review of four randomized controlled trials involving 385 teenagers.

Despite the promising results, the findings should be interpreted cautiously due to the limited number of studies and methodological concerns, highlighting the need for more well-designed clinical trials to further explore effective psychosocial care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for teenagers with adolescent idiopathic scoliosis: A systematic literature review. Yan, LI., Wong, AY., Cheung, JP., et al.[2023]

A study involving patients with idiopathic scoliosis found that 84% of parents described the initial bracing period as stressful, highlighting the emotional impact of brace treatment.

While bracewear did not significantly limit participation in many activities, it was associated with perceived limitations in sports and social events, and lower self-esteem during the initial treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress and coping with scoliosis: psychological effects on adolescents and their families. MacLean, WE., Green, NE., Pierre, CB., et al.[2022]

In a study of 40 female patients with idiopathic scoliosis, those treated with lateral electrical surface stimulation (LESS) showed significantly higher self-esteem and better coping mechanisms compared to those using traditional braces.

Patients in the brace group reported greater feelings of hostility and tended to avoid confronting their condition, while the LESS group was more proactive in dealing with their disease, suggesting psychological benefits of electrical stimulation over bracing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative results of psychologic testing in scoliosis patients treated with electrical stimulation or bracing. Kahanovitz, N., Snow, B., Pinter, I.[2019]

In a study of 113 adolescents aged 11-18 undergoing scoliosis surgery, those who used vigilant coping strategies before and one month after surgery engaged in more activities and performed better academically during recovery.

The study found that adolescents tended to be more vigilant in the hospital but became more avoidant one month post-surgery, highlighting the need for targeted interventions to support coping strategies during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents' coping with surgery for scoliosis: effects on recovery outcomes over time. LaMontagne, LL., Hepworth, JT., Cohen, F., et al.[2007]

Adolescent patients with idiopathic scoliosis (AIS) exhibited significantly higher levels of depression compared to juvenile patients (JIS), indicating that age and developmental stage may influence psychological outcomes in scoliosis treatment.

Factors such as longer bracing duration, larger spinal curvature (Cobb angle), and negative parental attitudes were associated with increased depression levels in both AIS and JIS patients, highlighting the importance of psychological support and family dynamics in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extent of Depression in Juvenile and Adolescent Patients with Idiopathic Scoliosis During Treatment with Braces. Lin, T., Meng, Y., Ji, Z., et al.[2020]

In a study of 46 adolescents with idiopathic scoliosis, no significant changes in behavioral and emotional function were observed over a 2-year treatment period, regardless of whether patients were treated with bracing, surgery, or observation.

Despite the lack of change in overall scores, a notable percentage of patients reported clinically significant issues such as anxiety and self-esteem problems, highlighting a gap in parental awareness of their children's emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent idiopathic scoliosis patients treated with bracing, surgery, or observation showed no difference in behavioral and emotional function over a 2-year period. Jalloh, H., Andras, LM., Sanders, A., et al.[2023]

Surgical correction of idiopathic scoliosis significantly improves self-image and mental health in both juveniles and adolescents, with both groups showing positive changes two years post-surgery.

Adolescents are at a higher risk for emotional maladjustment compared to juveniles, indicating that preoperative mental health and self-image are important predictors of postoperative outcomes, which should be considered in surgical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of emotional functioning in youth after surgical correction of idiopathic scoliosis. Zebracki, K., Thawrani, D., Oswald, TS., et al.[2013]

The study involving 36 females with adolescent idiopathic scoliosis (AIS) showed that their perception of trunk deformity improved over time while using a Cheneau brace, particularly between the first and third assessments.

Despite the improvements in trunk appearance perception, the overall body function and mental health scores did not significantly change during the treatment, indicating that while self-image may improve, emotional distress and low activity levels can still persist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception of stress level, trunk appearance, body function and mental health in females with adolescent idiopathic scoliosis treated conservatively: a longitudinal analysis. Misterska, E., Glowacki, M., Latuszewska, J., et al.[2022]

In a study of 124 patients with adolescent idiopathic scoliosis (AIS), 90% reported experiencing back pain, with varying intensities, indicating a high prevalence of pain among this population.

Psychological factors, particularly pain catastrophizing and mental health status, significantly influence the relationship between spinal deformity and pain intensity, suggesting that both physical and psychological assessments are crucial in managing AIS-related back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Back pain in adolescents with idiopathic scoliosis: the contribution of morphological and psychological factors. Teles, AR., St-Georges, M., Abduljabbar, F., et al.[2021]

In a study of 95 female patients treated with Milwaukee bracing for idiopathic scoliosis, significant psychological effects such as perceptions of discrimination and lower satisfaction with appearance were noted during treatment, but these effects diminished by the 7-year follow-up.

However, patients who underwent surgery (arthrodesis) continued to report a more negative body image compared to those treated with bracing alone and age-matched controls, indicating that surgical intervention may have long-lasting impacts on body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term psychosocial characteristics of patients treated for idiopathic scoliosis. Noonan, KJ., Dolan, LA., Jacobson, WC., et al.[2022]

Psychotherapy, including cognitive behavioral treatment and hypnotherapy, significantly improved the mental and physical condition of a 28-year-old female patient with conversion scoliosis, highlighting the importance of addressing psychological factors in chronic pain management.

The positive effects of the combined therapeutic approach, which included physical therapy and activity adaptation, were sustained for at least one year after treatment, suggesting long-term benefits of integrating psychological care in managing somatic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An unusual case of non-structural scoliosis (case report)]. Coupková, V., Vlach, O., Chaloupka, R.[2016]

Citations

1. link.springer.com link.springer.com/article/10.1007/s00586-023-07908-w

Impact of mental health components on the development ... This study aimed to assess the prevalence and intensity of back pain during young adulthood in subjects with adolescent idiopathic scoliosis (AIS),

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10008171/

Effectiveness of psychosocial interventions for pediatric ... Anxiety and pain management are key concerns for patients with scoliosis undergoing surgery. We found some evidence to support using brief ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3597283/

Prospective Assessment of Scoliosis-Related Anxiety and ... The aim of this study is to make a prospective analysis of changes in anxiety levels and determining their associations with a longitudinal ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596323003147

Psychosocial interventions for teenagers with adolescent ... Psychosocial interventions are generally feasible and acceptable among the adolescent idiopathic scoliosis population and have produced positive effects.

5. aoao.org aoao.org/2024/08/22/psychological-impact-of-brace-treatment-on-adolescents-with-idiopathic-scoliosis-a-narrative-review/

Psychological Impact of Brace Treatment on Adolescents ... The current literature states that 72% of teens diagnosed with AIS report feeling psychologically affected by having to wear a brace.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5745296/

Development of the Aim To Decrease Anxiety and Pain ... Findings from this study suggest that targeting both pain and anxiety may positively impact outcomes in youth with FAPD. The ADAPT intervention has the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04063670

NCT04063670 | Coping After Pediatric Scoliosis Surgery The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.

8. jposna.org jposna.org/index.php/jposna/article/view/592/763

Exploring the Potential of a Perioperative Psychosocial ... The purpose of this study was to assess the feasibility of a novel, web-based, perioperative psychosocial intervention focused on teaching healthy coping ...