N/A
Completed N=359
Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
Postoperative Pain · Depression, Anxiety · Opioid Use Disorder
Source: ClinicalTrials.gov NCT04419168 ↗
Enrolled (actual)
359
Serious AEs
1.1%
Results posted
Feb 2025
Primary outcomePrimary: 6-month Change in PROMIS Pain Interference — -2.13; -2.66 T-score — p=.57
Summary
The investigators are conducting a comparative effectiveness trial among adult patients with sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent if requested or needed) follow-up with a health coach for at least 3 months to reinforce learned materials. Both groups will also use their mobile device to track daily pain, mood, and medication used for two-week periods at baseline and each of the follow-up points (3, 6 and 12 months). Participants will also be given access to a study-associated online support group page where members can discuss with other patients, issues participants faced and what skills were or could be used to address them. Participants will continue all routine care including opioid pain management and novel therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-month Change in PROMIS Pain Interference |
-2.13; -2.66 | .57 |
| SECONDARY 6-month Change in Daily Pain Intensity |
0.20; 0.13 | 0.79 |
| SECONDARY 6-month Change in Patient Health Questionnaire (PHQ) |
-1.33; -1.12 | 0.75 |
| SECONDARY 6-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7) |
-0.85; -1.49 | 0.31 |
| SECONDARY 6-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) |
2.45; 2.34; 3.51; 1.79 | 0.91 |
| SECONDARY 6-month Change in Sickle Cell Self-Efficacy Scale (SCSES) |
1.45; 0.32 | 0.12 |
| SECONDARY Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 6 Months |
-0.0338; -0.0314 | 0.91 |
| SECONDARY 12-month Change in PROMIS Pain Interference |
-1.50; -1.93 | 0.68 |
| SECONDARY 12-month Change in Daily Pain Intensity |
0.06; -0.02 | 0.75 |
| SECONDARY 12-month Change in Patient Health Questionnaire (PHQ) |
-1.34; -0.24 | 0.14 |
| SECONDARY 12-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7) |
-0.70; -0.46 | 0.75 |
| SECONDARY 12-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) |
2.31; 1.61; 3.03; 1.03 | 0.49 |
| SECONDARY 12-month Change in Sickle Cell Self-Efficacy Scale (SCSES) |
1.50; -0.63 | 0.008 sig |
| SECONDARY 12-month Change in Current Opioid Misuse Measure (COMM) |
-1.72; -1.38 | 0.56 |
| SECONDARY Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 12 Months |
-0.05; -0.05 | 0.95 |
| SECONDARY Number of Opioid Prescriptions |
30.15; 27.19 | 0.49 |
| SECONDARY Number of Emergency Department Visits |
2.65; 1.86 | 0.10 |
| SECONDARY Number of Hospitalizations |
1.16; 0.89 | 0.22 |
Eligibility Criteria
Inclusion Criteria
- People with any type of sickle cell disease
- Male or female, age 18 years or older
- Reports chronic pain: i.e pain more days that not for the past 3 months or longer and/or is prescribed daily or long-acting opioids for pain.
- English speaking
Exclusion Criteria
- Any potential participants who fail consent comprehension questions
Data sourced from ClinicalTrials.gov (NCT04419168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.