Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention

Study Overview
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Brief Summary
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This study evaluates a Decision Aid to help patients with de Quervain's tenosynovitis decide how to treat their condition. For patients with symptoms of depression, half the participants will receive a psychological intervention (Toolkit) to improve depression and pain from de Quervain's tenosynovitis. The investigators hypothesize that both the Decision Aid and the Toolkit will be feasible, and that the Toolkit will improve pain and function compared to usual care.

Detailed Description
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The investigators are doing this research to see if they can improve the management of patients with de Quervain's tendinopathy. In the first part of this study, a Decision Aid (DA) has been developed to help participants make choices about their treatment. Decision aids are designed to provide patients with balanced, complete, and understandable information about their options for management of their condition, as well as risks and benefits, in order to help them determine their preferences according to their values. Research has shown that patients felt more knowledgeable and better informed with a more active role in decision making after using DAs. Additionally, research has shown that depression affects pain and disability experienced by patients with de Quervain's tenosynovitis. In the second part of our study, the investigators want to see whether a web based skills intervention (Toolkit) is more effective than usual medical care in improving pain and disability in patients with de Quervain's tenosynovitis and symptoms of depression. The Toolkit is delivered online and can be accessed at home. Similar skills interventions in patients with musculoskeletal injury have been shown to improve pain and function.

Official Title
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Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention

Conditions
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De Quervain Disease

Intervention / Treatment
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* Other: Decision Aid
* Behavioral: Toolkit for de Quervain's


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥18 years) diagnosed with de Quervain's tenosynovitis English fluency and literacy Ability to give informed consent Exclusion Criteria: Inability or unwillingness to participate in decision aid (DA) and/or Toolkit-depression Major medical comorbidity expected to worsen in the next 6 months Comorbid chronic pain condition Antidepressant medications changes in the past 6 months Severe and untreated mental health conditions or active substance dependence Secondary gains such as litigations or worker compensation procedures that may interfere with patients' motivation for treatment No online device available to use the DA and Toolkit-depression

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual care, no depression<br>Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care | Other: Decision Aid<br>* A website that contains information about de Quervain's tenosynovitis and the options for treatment<br>|
| Other: Usual care, depression<br>Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid) | Other: Decision Aid<br>* A website that contains information about de Quervain's tenosynovitis and the options for treatment<br>|
| Active Comparator: Toolkit, depression<br>Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care | Other: Decision Aid<br>* A website that contains information about de Quervain's tenosynovitis and the options for treatment<br>Behavioral: Toolkit for de Quervain's<br>* A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuickDASH score (Disabilities of the Arm Shoulder and Hand) | This questionnaire measures individual's ability to complete daily tasks and the severity of their symptoms. The scoring scale ranges from 0 (no disability) to 100 (most severe disability). | 6 months | 
| Numerical Pain Rating Scale | This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9 | This questionnaire is used for screening and measuring the severity of depression. The scale ranges from 0 to 27 overall. A score between the range of 5-9 indicates minimal symptoms of depression. A score between 10-14 suggests minimal depression or mild, major depression. A range of 15-19 indicates moderately severe, major depression, and a score of greater than 20 suggests severe, major depression. | 6 months | 
| Pain Catastrophizing Scale | This scale measures the individual's level of catastrophic thinking related to pain. They are asked about the thoughts and feelings they have when experiencing pain. The responses range from 0 (not at all) to 4 (all the time). The total score ranges from O-52. There are three subscale scores that assess rumination, magnification, and helplessness. The helplessness score ranges from 0 (not helpless) to 24 (severe helplessness). The rumination score ranges from 0 (don't think about the pain) to 16 (constantly think about how much it hurts). The magnification score ranges from 0 (does not feel like the pain is or will be more serious) to 12 (thinks the pain will get more serious). | 6 months |