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WithdrawnNCT03083340Updated Jun 15, 2026

Implementation of a Self-Help Depression Program Among Orthopedic Patients

An interventional study of Deprexis in MDD, sponsored by Jasper A. Smits. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Jasper A. Smits · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Feasibility concerns regarding recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • MDD
03

In context

Lead sponsor

Jasper A. Smits is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Injury or illness best treated with prompt surgery
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Deprexis

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

    Behavioral: Deprexis

Interventions

  • BehavioralDeprexis

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 Weeks

  3. 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.

    Time frame: 8 Weeks

  4. 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.

    Time frame: 8 Weeks

  5. 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.

    Time frame: 8 Weeks

  6. 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.

    Time frame: 8 Weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

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Study locations

1 site
  • University of Texas at Austin
    Austin, Texas 78712, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03083340
Lead sponsor
Jasper A. Smits
Responsible party
Jasper A. Smits (Principal Investigator, University of Texas at Austin) — Sponsor-investigator
First posted
Mar 20, 2017
Start date
Apr 1, 2017
Primary completion
Aug 1, 2017
Completion
Aug 1, 2017
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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