DepressionNCT04343534
Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
An observational study of Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
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.
Read the 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.
- Conditions
- Depression
- Keywords
- shared decision making
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Original Shared Decision Making Process scale | Patients receive the original version of the Shared Decision Making Process scale. | |
| Revised Shared Decision Making Process scale | This group completes a new version of the scale with different wording for several items. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making Process Score
The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores for both versions of the scale range from 0-4 where higher values indicate a better shared decision making process occurred.
Measured: Baseline survey
Secondary outcomes (8)
Decisional Conflict Tool (SURE)
Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates high decisional conflict, 4 indicates no decisional conflict, and scores less than or equal to 3 indicate decisional conflict. The measure is top-scored and we report the percentage of participants who scored a 4 ("no decisional conflict).
Measured: Baseline survey
Decision Regret Scale
5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
Measured: Baseline survey
Single-Item Measure of Decision Regret
Single item asking "If you knew then what you know now, do you think you would make the same decision about depression?" Responses are definitely yes, probably yes, probably no and definitely no.
Measured: Baseline survey
Treatment Preference
Single item asking "What did you want to do to manage your depression" with response options (1) Anti-depressant medicine alone, (2) Counseling or therapy alone, (3) Both medicine and counseling, and (4) Do something else.
Measured: Baseline survey
Adapted Controlled Preference Scale
Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.
Measured: Baseline survey
Shared Decision Making Process Measure Retest
The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.
Measured: 1 week after baseline survey
Depression Knowledge
Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge
Measured: Baseline survey
Adherence
3 item measure of adherence to medication for sample participants who indicate that they are taking medicine. A total score is calculated with scores ranging form 0-100; higher values indicated greater medication adherence.
Measured: Baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start29 Apr 2020
- Primary completion1 Jun 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343534
- Sponsor's protocol ID
- 2019P001434-2
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2020
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
- ClinicalTrials.gov ID
- NCT04343534
- Acronym / sponsor ID
- 2019P001434-2
- Conditions
- Depression
- Keywords
- shared decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Original Shared Decision Making Process scale | – | –Patients receive the original version of the Shared Decision Making Process scale. |
| Revised Shared Decision Making Process scale | – | –This group completes a new version of the scale with different wording for several items. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shared Decision Making Process Score
Time frame: Baseline survey
The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores for both versions of the scale range from 0-4 where higher values indicate a better shared decision making process occurred.
8 secondary outcomes
Decisional Conflict Tool (SURE)
Time frame: Baseline survey
Decision Regret Scale
Time frame: Baseline survey
Single-Item Measure of Decision Regret
Time frame: Baseline survey
Treatment Preference
Time frame: Baseline survey
Adapted Controlled Preference Scale
Time frame: Baseline survey
Shared Decision Making Process Measure Retest
Time frame: 1 week after baseline survey
Depression Knowledge
Time frame: Baseline survey
Adherence
Time frame: Baseline survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making Process Score (time frame: Baseline survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.