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

Not Applicable

Terminated

• Conditions: De Quervain Disease
• Interventions: Other: Decision Aid; Behavioral: Toolkit for de Quervain's

• Registration Number: NCT04069741
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Primary Completion: 2022-02-19
• Study Completion: 2022-02-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care, no depression	Decision Aid	Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care
Usual care, depression	Decision Aid	Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid)
Toolkit, depression	Toolkit for de Quervain's	Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care
Toolkit, depression	Decision Aid	Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care

Primary Outcome Measures

Name	Time	Method
Numerical Pain Rating Scale	6 months	This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain).
QuickDASH score (Disabilities of the Arm Shoulder and Hand)	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).

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9	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.
Pain Catastrophizing Scale	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).

Trial Locations

Locations (1)

Hand and Arm Center, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States