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

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ClinicalTrials.gov Identifier: NCT04069741
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Neal Chung-Jen Chen, Massachusetts General Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
De Quervain Disease Other: Decision Aid Behavioral: Toolkit for de Quervain's Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Usual care, no depression
Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care
Other: Decision Aid
A website that contains information about de Quervain's tenosynovitis and the options for treatment

Usual care, depression
Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid)
Other: Decision Aid
A website that contains information about de Quervain's tenosynovitis and the options for treatment

Active Comparator: Toolkit, depression
Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care
Other: Decision Aid
A website that contains information about de Quervain's tenosynovitis and the options for treatment

Behavioral: Toolkit for de Quervain's
A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis




Primary Outcome Measures :
  1. QuickDASH score (Disabilities of the Arm Shoulder and Hand) [ Time Frame: 6 months ]
    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).

  2. Numerical Pain Rating Scale [ Time Frame: 6 months ]
    This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain).


Secondary Outcome Measures :
  1. Patient Health Questionnaire 9 [ Time Frame: 6 months ]
    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.

  2. Pain Catastrophizing Scale [ Time Frame: 6 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069741


Locations
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United States, Massachusetts
Hand and Arm Center, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Neal C Chen, MD Hand and Arm Center Lead, Massachusetts General Hospital
Principal Investigator: Ana-Maria Vranceanu, PhD IBHCRP, Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Neal Chung-Jen Chen, Massachusetts General Hospital:
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Responsible Party: Neal Chung-Jen Chen, Interim Chief of the Hand & Arm Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04069741    
Other Study ID Numbers: 2018P002064
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tenosynovitis
De Quervain Disease
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Entrapment