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

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.

Study Overview

• Status: Terminated
• Conditions: De Quervain Disease
• Intervention / Treatment: Other: Decision Aid; Behavioral: Toolkit for de Quervain's

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Hand and Arm Center, Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): February 19, 2022
• Study Completion (Actual): February 19, 2022

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Tenosynovitis; De Quervain Disease
• Other Study ID Numbers: 2018P002064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No