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Cognitive Behavioral Therapy

Mobile CBT + tDCS for Chronic Pain after Bone Sarcoma

N/A

Recruiting

Led By Tara Brinkman, Phd

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks from start of feasibility study

Awards & highlights

Study Summary

This trial will gather input from Black & Hispanic childhood cancer survivors to adapt a mobile CBT program & tDCS procedures for chronic pain. Then, 90 participants will be tested to assess the program's feasibility.

Who is the study for?

This trial is for non-Hispanic Black and Hispanic survivors of pediatric bone sarcoma, aged 10-17 years, who are at least one year post-treatment. They must experience chronic pain that affects their daily life. Adults can participate if they're a survivor or parent of a survivor, over 18 years old.Check my eligibility

What is being tested?

The study is testing a mobile Cognitive Behavior Therapy (CBT) program adapted for cultural relevance, combined with either real or sham Transcranial Direct Current Stimulation (tDCS). The goal is to see if this combination helps manage chronic pain in adolescent cancer survivors.See study design

What are the potential side effects?

Possible side effects may include discomfort from the tDCS device like itching or tingling on the scalp, fatigue after therapy sessions, and potential emotional distress from discussing painful experiences during CBT.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks from start of feasibility study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks from start of feasibility study

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks from start of feasibility study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

Cancer-related worry

Depression

+11 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: InterviewExperimental Treatment1 Intervention

Participants attend virtual meetings and virtual focus groups during the cultural adaptation phase. Feedback is collected and analyzed to develop the finalized adaptation.

Group II: Arm I (mobile CBT + active tDCS)Experimental Treatment3 Interventions

Participants receive mobile CBT and undergo active tDCS to the dorsolateral prefrontal cortex (DLPFC) over 20 minutes twice a week for 6 weeks.

Group III: Arm II (mobile CBT + sham tDCS)Placebo Group3 Interventions

Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavior Therapy

2010

Completed Phase 3

~2630

Transcranial Direct Current Stimulation

2014

Completed Phase 3

~1100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,538 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,801 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,954 Total Patients Enrolled

Media Library

Cognitive Behavior Therapy (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05746429 — N/A

Bone Sarcoma Research Study Groups: Arm I (mobile CBT + active tDCS), Arm II (mobile CBT + sham tDCS), Interview

Bone Sarcoma Clinical Trial 2023: Cognitive Behavior Therapy Highlights & Side Effects. Trial Name: NCT05746429 — N/A

Cognitive Behavior Therapy (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746429 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there capacity for new participants in this experiment?

"Affirmative. Clinicaltrials.gov hosts evidence that this medical experiment, initially posted on February 9th 2023, is currently recruiting volunteers. Approximately 75 patients are needed from a single clinical trial site."

Answered by AI

What is the cap for participation in this medical experiment?

"Affirmative. Clinicaltrials.gov illustrates that this experimental trial, which was published on February 9th 2023, is currently searching for participants. Approximately 75 people need to be enrolled from 1 medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Bone Sarcoma

2023. "Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Bone Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746429.

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