Psychosocial Interventions for Young Adults With Hip Pain

NCT04039386 | Not Yet Recruiting FDA Device

• 1 other identifier: 1111
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. The goal of this project is to determine the incidence of psychosocial conditions in the young adult population with hip pain and determine if cognitive based therapy can improve clinical outcomes in these individuals.

Conditions

Hip Dysplasia; Hip Pain Chronic; Hip Osteoarthritis; Hip Arthritis; Psychosocial Problem

Keywords

Hip Pain; Hip Instability; Hip Impingement; Cognitive Based Therapy; Psychosocial Conditions

Outcome Measures

Primary Outcomes (14)

• Changes in level of Depression (DASS-21)

  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.

  8 weeks

• Changes in level of Depression (PROMIS)

  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.

  8 weeks

• Changes in level of Anxiety (DASS-21)

  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.

  8 weeks

• Changes in level of Anxiety (PROMIS)

  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.

  8 weeks

• Changes in level of Stress (DAAS-21)

  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.

  8 Weeks

• Evaluating the presence and severity of Kinesiophobia

  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.

  8 weeks

• Evaluation of Resiliency

  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.

  8 weeks

• Evaluation of Grit

  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.

  8 weeks

• Evaluating the presence and severity of Pain Catastrophizing

  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.

  8 weeks

• Evaluating Self-Efficacy

  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.

  8 weeks

• Evaluating the presence and severity of Alcohol Use Disorders

  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.

  8 weeks

• Changes in Physical Function (PROMIS)

  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.

  8 weeks

• Changes in Physical Function (HOOS)

  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

  8 weeks

• Reduced Opioid Use

  Measured via self reported opioid use after surgery

  8 weeks

Study Arms (2)

Cell Phone Based Cognitive Based Therapy

EXPERIMENTAL

Young adults with hip pain

Device: Cell Phone Based Cognitive Based Therapy (Pacifica App)

Placebo

PLACEBO COMPARATOR

Young adults with hip pain

Other: Control

Interventions

Cell Phone Based Cognitive Based Therapy (Pacifica App) DEVICE

Cell phone application that provides support for individuals with psychosocial conditions.

Cell Phone Based Cognitive Based Therapy

Control OTHER

Subjects in the control group will receive standard care.

Also known as: Standard Care

Placebo

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• We will enroll young adults (15-39) presenting to one of several physical therapy and orthopedic practices in the state of Iowa for treatment of nonarthritic hip pain.
• Chief complaint of hip pain or dysfunction, and a diagnosis of a nonarthritic hip condition including labral tear, femoroacetabular impingement (FAI), snapping hip, femoral anteversion or dysplasia.

You may not qualify if:

• Difficulty with written English
• Treatment for alternative conditions such as trochanteric bursitis, hip dislocation, avascular necrosis or fracture.

Sponsors & Collaborators

• Michael C Willey: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hip Dislocation; Osteoarthritis, Hip

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Osteoarthritis; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elizabeth Scott, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael C Willey

CONTACT

3193561616; michael-willey@uiowa.edu

John Davison, MPH

CONTACT

3193846529; john-davison@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: July 31, 2019
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)