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

Mass General Brigham

Status: Terminated

Conditions: De Quervain Disease

Treatments: Other: Decision Aid; Behavioral: Toolkit for de Quervain's

Study type: Interventional

Funder types: Other

Identifiers

NCT04069741

2018P002064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Usual care, no depression

Other group

Description:

Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care

Treatment:

Other: Decision Aid

Usual care, depression

Other group

Description:

Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid)

Treatment:

Other: Decision Aid

Toolkit, depression

Active Comparator group

Description:

Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care

Treatment:

Other: Decision Aid

Behavioral: Toolkit for de Quervain's