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Implementation of a Self-Help Depression Program Among Orthopedic Patients

Primary Purpose

MDD

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deprexis
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MDD

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas at Austin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deprexis

Arm Description

Participants will complete 8 weeks of online treatment via a web-based program, Deprexis.

Outcomes

Primary Outcome Measures

Proof of Concept - Acceptability measured by number of eligible participants that choose to participate
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 number of modules completed on the online program
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 qualitative feedback
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
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
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 - Feasibility measured by qualitative feedback
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.

Secondary Outcome Measures

Level of Improvement of Depression (by scores on the PHQ-9)
Secondary outcome measures will be the level of depressive symptoms as evidenced by scores on the PHQ-9.
Level of Improvement of Functioning (by scores on the PROMIS Physical Function CAT)
Secondary outcome measure will be the level of improvement in upper and lower extremity function as measured by scores on the PROMIS Physical Function CAT.

Full Information

First Posted
February 24, 2017
Last Updated
October 10, 2018
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03083340
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Feasibility concerns regarding recruitment
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deprexis
Arm Type
Experimental
Arm Description
Participants will complete 8 weeks of online treatment via a web-based program, Deprexis.
Intervention Type
Behavioral
Intervention Name(s)
Deprexis
Intervention Description
Participants will complete an 8 week self-help computerized treatments through a web-based online Deprexis program.
Primary Outcome Measure Information:
Title
Proof of Concept - Acceptability measured by number of eligible participants that choose to participate
Description
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.
Time Frame
8 weeks
Title
Proof of Concept - Acceptability measured by number of modules completed on the online program
Description
The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.
Time Frame
8 Weeks
Title
Proof of Concept - Acceptability measured by qualitative feedback
Description
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.
Time Frame
8 Weeks
Title
Proof of Concept - Feasibility measured by number of eligible participants that choose to participate
Description
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.
Time Frame
8 Weeks
Title
Proof of Concept - Feasibility measured by number of modules completed on the online program
Description
The primary outcome will be the level of acceptability of the intervention as measured by number of completed modules on the online Deprexis program.
Time Frame
8 Weeks
Title
Proof of Concept - Feasibility measured by qualitative feedback
Description
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.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Level of Improvement of Depression (by scores on the PHQ-9)
Description
Secondary outcome measures will be the level of depressive symptoms as evidenced by scores on the PHQ-9.
Time Frame
8 weeks
Title
Level of Improvement of Functioning (by scores on the PROMIS Physical Function CAT)
Description
Secondary outcome measure will be the level of improvement in upper and lower extremity function as measured by scores on the PROMIS Physical Function CAT.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Implementation of a Self-Help Depression Program Among Orthopedic Patients

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