Implementation of a Self-Help Depression Program Among Orthopedic Patients

NCT03083340 | Withdrawn

• 1 other identifier: 2016-08-0089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

MDD

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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 Arms (1)

Deprexis

EXPERIMENTAL

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

Behavioral: Deprexis

Interventions

Deprexis BEHAVIORAL

Participants will complete an 8 week self-help computerized treatments through a web-based online Deprexis program.

Deprexis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Injury or illness best treated with prompt surgery

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 20, 2017
• Study Start: April 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)