Implementation of a Self-Help Depression Program Among Orthopedic Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: MDD
• Intervention / Treatment: Behavioral: Deprexis

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deprexis; Participants will complete 8 weeks of online treatment via a web-based program, Deprexis.	Behavioral: Deprexis; Participants will complete an 8 week self-help computerized treatments through a web-based online Deprexis program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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.	8 Weeks
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.	8 Weeks
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.	8 Weeks
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.	8 Weeks
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.	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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.	8 weeks

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2016-08-0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No