DepressionNCT01152307

Measuring Quality of Decisions About Treatment of Depression

A study testing DVD/Booklet: Coping with Symptoms of Depression in people with Depression, run by University of Massachusetts, Boston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: DVD/Booklet: Coping with Symptoms of Depression
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 405 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Dec 2010
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18+
In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)

Who cannot join

none

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Survey Research - University of Massachusetts Boston
Boston, Massachusetts, 02125

Other trials in United States

About this study

Conditions: Depression
Being tested: DVD/Booklet: Coping with Symptoms of Depression
Keywords: Depression, Depressive disorder, Decision Making, Decision Aids, Decision Quality Instrument
Medical subject headings: Depression, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DVD/Booklet: Coping with Symptoms of DepressionBehavioural
Also called Decision aids, Shared decision making programs
DVD and booklet that provides information about treatment choices for depression symptoms

Study groups in NCT01152307
Study group	Role	What they receive
Decision Aid	Experimental	Group receiving the decision aid (DVD/booklet) Receives: Behavioral: DVD/Booklet: Coping with Symptoms of Depression
Control	No intervention	Group not receiving the decision aid (DVD/booklet)

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression Knowledge
Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).
Measured: 2 weeks, on average

Secondary outcomes (1)

Value Concordance
Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs
Measured: 2 weeks, on average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Dec 2010

First posted29 Jun 2010 (estimated)
Study startJun 2010
Primary completionNov 2010
Study completionDec 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 405 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152307
Sponsor's protocol ID: CSR-DQ1-002
Status last verified: Jul 2012
First submitted: 22 Jun 2010
Last updated: 20 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Brodney S, Valentine KD, Sepucha K. Psychometric evaluation of a decision quality instrument for medication decisions for treatment of depression symptoms. BMC Med Inform Decis Mak. 2021 Aug 27;21(1):252. doi: 10.1186/s12911-021-01611-w.
PubMed 34445969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measuring Quality of Decisions About Treatment of Depression
ClinicalTrials.gov ID: NCT01152307
Acronym / sponsor ID: CSR-DQ1-002
Conditions: Depression
Keywords: Depression, Depressive disorder, Decision Making, Decision Aids, Decision Quality Instrument
Study type: Interventional
Recruitment status: Completed
Enrolment: 405 participants (actual)
Lead sponsor: University of Massachusetts, BostonUniversity, hospital or other
Collaborators: Foundation for Informed Medical Decision Making, Massachusetts General Hospital
Study start: Jun 2010
Primary completion: Nov 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 29 Jun 2010 (estimated)
Results: Posted 20 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Decision Aid	Experimental	Behavioral: DVD/Booklet: Coping with Symptoms of DepressionGroup receiving the decision aid (DVD/booklet)
Control	No intervention	–Group not receiving the decision aid (DVD/booklet)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Aged 18+
In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)

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.

Interventions

Intervention	Type	Arms
DVD/Booklet: Coping with Symptoms of DepressionAlso: Decision aids, Shared decision making programsDVD and booklet that provides information about treatment choices for depression symptoms	Behavioural	Decision Aid

Primary outcome

Depression Knowledge
Time frame: 2 weeks, on average
Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).

1 secondary outcome

Value Concordance
Time frame: 2 weeks, on average

Results and safety

Results posted to the registry on 20 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Decision Aid	191	191
Control	214	214

Primary outcome: Depression Knowledge

Time frame: 2 weeks, on average. Mean (Standard Deviation). Unit: percent of correct responses

Measure	Decision Aid n = 191	Control n = 214
Value	67.0 (14.1)	63.6 (12.5)

Decision Aid vs Control: Mean Difference (Net): 3.42 (95% CI 0.76 to 6.09), p = 0.01, t-test, 2 sided

Population analysed: Participants were randomized to receive the DVD and booklet.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: August 5, 2010 through January 10, 2011.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Decision Aid	0 of 191 (0%)	0 of 191 (0%)	Not reported
Control	0 of 214 (0%)	0 of 214 (0%)	Not reported

Limitations and caveats (from the sponsor): Those who answered fewer than half of the knowledge questions do not have a total knowledge score (primary outcome).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34445969Brodney S, Valentine KD, Sepucha K. Psychometric evaluation of a decision quality instrument for medication decisions for treatment of depression symptoms. BMC Med Inform Decis Mak. 2021 Aug 27;21(1):252. doi: 10.1186/s12911-021-01611-w.

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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Recruiting
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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.

Patricia M Gallagher, PhD study director

University of Massachusetts, Boston

Karen R Sepucha, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DVD/Booklet: Coping with Symptoms of Depression in people with Depression, run by University of Massachusetts, Boston 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 20 Aug 2012. 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 20 Aug 2012). 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?

Depression Knowledge (time frame: 2 weeks, on average). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152307, which also lists 1 linked publication.

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 20 Aug 2012.