Clinical trial NCT04343534: Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
Official title: Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: shared decision making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
First posted: 2020-04-13
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample of adults in the United States who have made decision about treatment of depression in the past 12 months will be recruited from an online panel.

Brief summary: The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of reliability, to test whether the generic version has similar psychometric performance to the original, and to extend generalizability of the findings to younger adults.

Detailed description: The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of psychometric performance of the scale, compare performance of different wording for items, and to extend generalizability of the findings to younger adults.

Subjects are randomly assigned to one of the two versions of the Shared Decision Making Process scale and complete a set of measures regarding their experiences with decision making for depression, demographics, and health status. A subset of respondents will complete the Shared Decision Making Process scale and selected other items again 1 week later to examine short term test-retest reliability.

Staff will work with a national sampling firm to recruit subjects and obtain 500 responses to the baseline survey (n=250 for each version) and a subset will complete a retest survey (n=200; 50 from each age and survey type group). Eligible subjects are adults aged 18-75 who talked with a health care provider about treatment for depression in the preceding 12 months. The sample is not a national probability sample; however, the recruitment efforts will ensure about 50% of respondents aged 18-39 and 50% aged 40-75, and to ensure at least 25% of the sample is racial/ethnic minorities (Black or African American, Asian, Hispanic or Latino).

The investigators will examine validity and reliability of the different versions. The sample size was determined to ensure sufficient power to detect differences in key subgroups, including age (younger adults vs. older adults) and version (A vs. B). To detect a difference of about 0.33 standard deviations at 0.05 significance with 80% power would require 125 per group.

Eligibility criteria: Inclusion Criteria:

* Must have spoken to a healthcare provider about treatment for depression in the past 12 months
* Must have started or stopped medication for depression between January 2018 and their surveyed date.

Exclusion Criteria:

* None

Primary outcomes:
measure: Shared Decision Making Process Score
timeFrame: Baseline survey
Secondary outcomes:
measure: Decisional Conflict Tool (SURE)
timeFrame: Baseline survey
measure: Decision Regret Scale
timeFrame: Baseline survey
measure: Single-Item Measure of Decision Regret
timeFrame: Baseline survey
measure: Treatment Preference
timeFrame: Baseline survey
measure: Adapted Controlled Preference Scale
timeFrame: Baseline survey
measure: Shared Decision Making Process Measure Retest
timeFrame: 1 week after baseline survey
measure: Depression Knowledge
timeFrame: Baseline survey
measure: Adherence
timeFrame: Baseline survey
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: