Implementation of a Self-Help Depression Program Among Orthopedic Patients

MDD Clinical Trial

Official title:

Implementation of a Self-Help Depression Program Among Orthopedic Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03083340
• Other study ID #: 2016-08-0089
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: October 2018
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• MDD

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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