WithdrawnNot Applicable

Implementation of a Self-Help Depression Program Among Orthopedic Patients

Stopped: Feasibility concerns regarding recruitment

United States0Started 2017-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proof of Concept - Acceptability measured by number of eligible participants that choose to participate

Timeframe: 8 weeks

Proof of Concept - Acceptability measured by number of modules completed on the online program

Timeframe: 8 Weeks

Proof of Concept - Acceptability measured by qualitative feedback

Timeframe: 8 Weeks

Proof of Concept - Feasibility measured by number of eligible participants that choose to participate

Timeframe: 8 Weeks

Proof of Concept - Feasibility measured by number of modules completed on the online program

Timeframe: 8 Weeks

Proof of Concept - Feasibility measured by qualitative feedback

Timeframe: 8 Weeks

Trial details

NCT IDNCT03083340

SponsorJasper A. Smits

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-01

View on ClinicalTrials.gov More MDD trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proof of Concept - Acceptability measured by number of eligible participants that choose to participate

Timeframe: 8 weeks

Proof of Concept - Acceptability measured by number of modules completed on the online program

Timeframe: 8 Weeks

Proof of Concept - Acceptability measured by qualitative feedback

Timeframe: 8 Weeks

Proof of Concept - Feasibility measured by number of eligible participants that choose to participate

Timeframe: 8 Weeks

Proof of Concept - Feasibility measured by number of modules completed on the online program

Timeframe: 8 Weeks

Proof of Concept - Feasibility measured by qualitative feedback

Timeframe: 8 Weeks