Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
Primary Purpose
De Quervain Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Toolkit for de Quervain's
Sponsored by
About this trial
This is an interventional treatment trial for De Quervain Disease
Eligibility 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
Sites / Locations
- Hand and Arm Center, Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Active Comparator
Arm Label
Usual care, no depression
Usual care, depression
Toolkit, depression
Arm Description
Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care
Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid)
Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care
Outcomes
Primary Outcome Measures
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).
Numerical Pain Rating Scale
This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain).
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT04069741
First Posted
August 16, 2019
Last Updated
April 29, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04069741
Brief Title
Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
Official Title
Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Data difficult to collect due to the COVID-19 pandemic.
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
February 19, 2022 (Actual)
Study Completion Date
February 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
De Quervain Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care, no depression
Arm Type
Other
Arm Description
Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care
Arm Title
Usual care, depression
Arm Type
Other
Arm Description
Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid)
Arm Title
Toolkit, depression
Arm Type
Active Comparator
Arm Description
Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
A website that contains information about de Quervain's tenosynovitis and the options for treatment
Intervention Type
Behavioral
Intervention Name(s)
Toolkit for de Quervain's
Intervention Description
A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis
Primary Outcome Measure Information:
Title
QuickDASH score (Disabilities of the Arm Shoulder and Hand)
Description
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).
Time Frame
6 months
Title
Numerical Pain Rating Scale
Description
This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire 9
Description
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.
Time Frame
6 months
Title
Pain Catastrophizing Scale
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal C Chen, MD
Organizational Affiliation
Hand and Arm Center Lead, Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
IBHCRP, Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hand and Arm Center, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
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