Skip to main content
Clinical Trials/NCT03083340
NCT03083340
Withdrawn
Not Applicable

Implementation of a Self-Help Depression Program Among Orthopedic Patients

University of Texas at Austin1 site in 1 countryApril 1, 2017
ConditionsMDD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
MDD
Sponsor
University of Texas at Austin
Locations
1
Primary Endpoint
Proof of Concept - Acceptability measured by number of modules completed on the online program
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
August 1, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Proof of Concept - Acceptability measured by number of modules completed on the online program

Time Frame: 8 Weeks

The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.

Proof of Concept - Acceptability measured by number of eligible participants that choose to participate

Time Frame: 8 weeks

The primary outcome will be the level of acceptability of the intervention as measured by the number of eligible participants who chose to participate in the intervention.

Proof of Concept - Acceptability measured by qualitative feedback

Time Frame: 8 Weeks

The primary outcome will be the level of acceptability of the intervention as measured by qualitative feedback following the intervention created by the investigators on how acceptable the study was for the participant.

Proof of Concept - Feasibility measured by qualitative feedback

Time Frame: 8 Weeks

The primary outcome will be the level of acceptability of the intervention as measured by qualitative feedback following the intervention created by the investigators on how acceptable the study was for the participant.

Proof of Concept - Feasibility measured by number of eligible participants that choose to participate

Time Frame: 8 Weeks

The primary outcome will be the level of feasibility of the intervention as measured by he number of eligible participants who chose to participate in the intervention.

Proof of Concept - Feasibility measured by number of modules completed on the online program

Time Frame: 8 Weeks

The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.

Secondary Outcomes

  • Level of Improvement of Depression (by scores on the PHQ-9)(8 weeks)
  • Level of Improvement of Functioning (by scores on the PROMIS Physical Function CAT)(8 weeks)

Study Sites (1)

Loading locations...

Similar Trials