Purpose

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

Conditions

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty. 2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment). 3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders. 4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI). 5. Referral and attendance of medical rehabilitation post-discharge.

Exclusion Criteria

  1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year). 2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded). 3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk. 4. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be assigned to either the a healthy habits group or a sleep habits group.
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Healthy Habits
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
  • Behavioral: Healthy Habits
    Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.
Other
Sleep Habits
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
  • Behavioral: Sleep Habits
    Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Emily Lantz, PhD
409-772-0643
ejlantz@utmb.edu

More Details

Status
Recruiting
Sponsor
Baylor College of Medicine

Study Contact

Doris Escobedo
713-487-5540
doris.escobedo@bcm.edu

Detailed Description

Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.