Implementation of a Self-Help Depression Program Among Orthopedic Patients

Sponsor

University of Texas at Austin (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03083340

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
MDD	Behavioral: Deprexis	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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).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)

Primary Purpose:

Treatment

Official Title:

Implementation of a Self-Help Depression Program Among Orthopedic Patients

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Level of Improvement of Depression (by scores on the PHQ-9) [8 weeks]
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) [8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Austin	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT03083340

Other Study ID Numbers:

2016-08-0089

First Posted:

Mar 20, 2017

Last Update Posted:

Oct 15, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Oct 15, 2018