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

De Quervain Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04069741
• Other study ID #: 2018P002064
• Status: Terminated
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: February 19, 2022

Study information

• Verified date: April 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: February 19, 2022
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• De Quervain Disease
• Tenosynovitis

Intervention

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

Locations

Country	Name	City	State
United States	Hand and Arm Center, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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