Clinical trial NCT04069741: 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
Overall status: TERMINATED
Phase: NA
Conditions: De Quervain Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: QuickDASH score (Disabilities of the Arm Shoulder and Hand)
timeFrame: 6 months
measure: Numerical Pain Rating Scale
timeFrame: 6 months
Secondary outcomes:
measure: Patient Health Questionnaire 9
timeFrame: 6 months
measure: Pain Catastrophizing Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Hand and Arm Center, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Hand and Arm Center Lead, Massachusetts General Hospital
name: Neal C Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IBHCRP, Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: