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Psychosocial Interventions for Young Adults With Hip Pain

ConditionsHip DysplasiaHip Pain ChronicHip OsteoarthritisHip ArthritisPsychosocial Problem
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-39
SponsorMichael C Willey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Exclusion criteria will include age <15 or >40 years

Difficulty with written English

Treatment for alternative conditions such as trochanteric bursitis, hip dislocation, avascular necrosis or fracture.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cell Phone Based Cognitive Based Therapy (Pacifica App)

    Device

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

  • Control

    Other intervention

    Subjects in the control group will receive standard care.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Cell Phone Based Cognitive Based TherapyExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michael C Willey

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: