Psychosocial Interventions for Young Adults With Hip Pain
This study is looking at how psychosocial factors (like depression and anxiety) affect young adults (ages 15-39) with hip pain caused by conditions like hip dysplasia or labral tears. Researchers want to see if using a cell phone app called Pacifica, which provides cognitive based therapy (a type of talk therapy), can help improve these psychosocial conditions and overall outcomes. The study will compare people using the Pacifica app to those receiving standard care. Success will be measured by changes in depression and anxiety levels after 8 weeks.
- Study design
- This interventional study plans to enroll 150 young adults and compares a cell phone app intervention to standard care.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' depression and anxiety levels will be measured at 8 weeks.
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Psychosocial Interventions for Young Adults With Hip Pain
At a glance
Conditions
NCT04039386
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Iowa
Iowa City, Iowastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Elizabeth Scott, MD · PRINCIPAL_INVESTIGATOR · University of Iowa
Who to contact
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Inclusion
Exclusion
What this trial measures
- Changes in level of Depression (DASS-21)8 weeks
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire * General adult population average total score: 9.43 (standard deviation (SD) 9.66), out of a total possible score of 63 points, * Indication of significant difference from normative data: Average score \>1 SD above the General adult population average total score * General adult population average depression sub scale score: 2.83 (SD 3.87) * Values above 9.03 points in the depression subsection score correlate with clinical depression and generalized anxiety disorders * A change of 3.86 or more points in the depression subscore reliably represents clinical improvement.
- Changes in level of Depression (PROMIS)8 weeks
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Depression. An electronically administered patient reported outcome questionnaire * Normative T-score generated from US adult population data: mean 50 (SD 10). * For this study, an average T-score \<40 would be considered significantly different compared to normative values. * The minimally important difference (MID) of 3.0-3.1 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
- Changes in level of Anxiety (DASS-21)8 weeks
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire * General adult population average total score: 9.43 (SD 9.66) * An average total score \>1 SD above the mean would be considered significantly different from normative data * General adult population average anxiety subscale scores: 1.88±2.95 * Average anxiety subsection score above 6.27 correlate with clinical depression and generalized anxiety disorders * A change of 3.85 or more points in the anxiety subscore reliably represents clinical improvement.
- Changes in level of Anxiety (PROMIS)8 weeks
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Anxiety. An electronically administered patient reported outcome questionnaire * Normative T-score generated from US adult population data: mean 50 (SD 10). * For this study, an average T-score \<40 would be considered significantly different compared to normative values. * The minimally important difference (MID) of 2.3 to 3.4 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
- Changes in level of Stress (DAAS-21)8 Weeks
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire * General adult population average total score: 9.43 (SD 9.66) * An average total score \>1 SD above the mean would be considered significantly different from normative data * General adult population average stress subscale scores: 4.73±4.20 * Average stress subsection score above 12.27 correlate with clinical depression and generalized anxiety disorders * A change of 4.90 or more points in the anxiety subscore reliably represents clinical improvement.
- Evaluating the presence and severity of Kinesiophobia8 weeks
Assessed via the Shortened Tampa Scale for Kinesiophobia (TSK-11) electronically administered patient reported outcome questionnaire * The survey is a 11-question test scored from 11-44, where higher scores indicate increasing fear of movement. * A value of 11 is presumed in a nonpainful population. * Adults with chronic musculoskeletal pain undergoing outpatient chronic pain therapy report an average TSK score of 30.4 (+/- 6.6). * Successful evaluation of Kinesiophobia will be indicated if increases in TSK-11 scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
- Evaluation of Resiliency8 weeks
Assessed via The Brief Resiliency Scale (BRS) electronically administered patient reported outcome questionnaire * An 8 question survey scored from 1-5 points * The average score for US adults age 24-34 is 3.2 (SD 0.7) * A statistically significant lower Grit score would be \>1SD below this average value. * Successful evaluation of Grit will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
- Evaluation of Grit8 weeks
Assessed via The Short Grit Scale (GRIT-S) electronically administered patient reported outcome questionnaire * A 6-question test with low resiliency defined as a score of \<3.00. * Prior descriptive studies indicate an average score of 3.57 (SD 0.76) for young adults age 19.8±3.0 years. * Statistically significant lower resilience would be \>1SD below this average value. * Successful evaluation of Resiliency will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents (for those tests where this data exists) would also be considered a successful finding.
- Evaluating the presence and severity of Pain Catastrophizing8 weeks
Assessed via Pain Catastrophizing Scale (PCS) electronically administered patient reported outcome questionnaire * Scored on a 13 point scale. * Normative average values from a population of adults adults age 42.2 (17-63 years) with low back pain: mean 20.90 (SD 12.5), * Successful evaluation of Pain Catastrophization will be indicated if increases in PCS scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
- Evaluating Self-Efficacy8 weeks
Assessed via The General Self-Efficacy Scale (GSE) electronically administered patient reported outcome questionnaire * 10-question test, scored from 10-40, with lower scores representing low self efficacy. * Average US adult values: 29.48 (SD 5.13) * Successful evaluation of Self-Efficacy will be indicated if increases in GSE scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
- Evaluating the presence and severity of Alcohol Use Disorders8 weeks
Assessed via Alcohol Use Disorders Identification Test (AUDIT) electronically administered patient reported outcome questionnaire * A 10-question test with a threshold score \>7 considered "AUDIT-positive", indicating risky or hazardous alcohol use behavior. * National data suggests 15-20% of US 14-18 year olds screen positive * Successful evaluation of Alcohol Use Disorders will be indicated if increases in AUDIT scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
- Changes in Physical Function (PROMIS)8 weeks
Measured via the following electronically administered patient reported outcome questionnaires. * PROMIS: Physical Function (PF) * Normative T-score generated from US adult population data: mean 50 (SD 10). * For this study, an average T-score \<40 would be considered significantly different compared to normative values. * The minimally important difference (MID) of 1.9 - 2.2 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
- Changes in Physical Function (HOOS)8 weeks
Measured via the following electronically administered patient reported outcome questionnaires. * The Hip disability and osteoarthritis outcome score (HOOS) * Scored from 0-100 * Increasing score represent better function. * Average scopres for hip preservation patients prior to surgery is well established
- Reduced Opioid Use8 weeks
Measured via self reported opioid use after surgery