Clinical trial NCT03083340: Implementation of a Self-Help Depression Program Among Orthopedic Patients
Official title: Implementation of a Self-Help Depression Program Among Orthopedic Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: MDD
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Deprexis consists of 10 content modules representing different psychotherapeutic approaches, plus one introductory and one summary module, each of which can be completed in 10 to 60 minutes, depending on the user's reading speed, interest, motivation, and individual path through the program (Meyer, et al., 2009).
Primary purpose: TREATMENT

Brief summary: The proposed study addresses the potential utility of providing an accessible self-help intervention for patients in a medical setting with an estimated diagnosis of MDD. Specifically, the study will explore whether a) such an intervention can be effectively implemented in a primary care setting and b) patients originally seeking medical attention for an orthopedic problem will be willing to seek psychological treatment and, c) improvement in depression symptoms will lead to improvement in upper and lower extremity functioning.

Detailed description: The present project will be an open-label trial to assess the feasibility and acceptability of a self-help intervention among a sample of orthopedic patients. In addition to monitoring the effectiveness of the Deprexis program on depressive symptoms, the proposed project will assess whether a reduction in depressive symptoms will be associated with improvement on patient reported orthopedic impairment. The investigators will enroll 50 adults and the participants will be given the opportunity to participate in 8 weeks of the web-based online Deprexis program.

Eligibility criteria: Inclusion Criteria:

* All patients older than 18 years who present to a surgeon with an upper or lower extremity injury or disability at a participating center (see attached list)
* A level of clinical depression more than minimal symptoms as defined by a score ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9)
* Willing and able to provide informed consent and comply with the protocol

Exclusion Criteria:

* Injury or illness best treated with prompt surgery

Primary outcomes:
measure: Proof of Concept - Acceptability measured by number of eligible participants that choose to participate
timeFrame: 8 weeks
measure: Proof of Concept - Acceptability measured by number of modules completed on the online program
timeFrame: 8 Weeks
measure: Proof of Concept - Acceptability measured by qualitative feedback
timeFrame: 8 Weeks
measure: Proof of Concept - Feasibility measured by number of eligible participants that choose to participate
timeFrame: 8 Weeks
measure: Proof of Concept - Feasibility measured by number of modules completed on the online program
timeFrame: 8 Weeks
measure: Proof of Concept - Feasibility measured by qualitative feedback
timeFrame: 8 Weeks
Secondary outcomes:
measure: Level of Improvement of Depression (by scores on the PHQ-9)
timeFrame: 8 weeks
measure: Level of Improvement of Functioning (by scores on the PROMIS Physical Function CAT)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References: