DepressionPhase 4NCT00055328
Treatment for Depression in the Primary Care Setting
A Phase 4 study testing Problem-Solving Treatment for Primary Care in people with Depression, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study will compare a brief form of counseling to usual care for the treatment of minor depression in the primary care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Problem-Solving Treatment for Primary Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Primary care patient at Dartmouth-Hitchcock Medical Center (DHMC)
- Hamilton Depression Score >= 10 and minor depression at time of entry and after 4 weeks of observation
Who cannot join
- Psychosis, Obsessive Compulsive Disorder (OCD), or Post Traumatic Stress Disorder (PTSD)
- Active substance abuse
- Receiving treatment for depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Problem-Solving Treatment for Primary Care Depression
This study will compare a brief form of counseling to usual care for the treatment of minor depression in the primary care setting.
Read the detailed description
Minor depression is one of the most common types of depressive disorders seen in primary care. The effectiveness and tolerability of antidepressants in patients with minor depression is unclear, and the development of alternative treatments is necessary.
In the first phase of this study, participants are observed for 4 weeks to identify those most in need of depression-specific treatment. Participants are then exposed to the Problem-Solving Treatment for Primary Care (PST-PC), a six-session behavioral treatment for depression. After 4 weeks, patients who do not respond adequately to the treatment are randomly assigned to either continued PST-PC or to usual care for 9 weeks. Participants are followed for 6 months after the study.
- Conditions
- Depression
- Being tested
- Problem-Solving Treatment for Primary Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving Treatment for Primary CareBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2003 (estimated)
- Study startDec 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055328
- Sponsor's protocol ID
- R01MH062322
- Other IDs
- R01MH062322, DATR A4-GPS
- Status last verified
- Aug 2008
- First submitted
- 25 Feb 2003
- Last updated
- 10 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem-Solving Treatment for Primary Care Depression
- ClinicalTrials.gov ID
- NCT00055328
- Acronym / sponsor ID
- R01MH062322
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare a brief form of counseling to usual care for the treatment of minor depression in the primary care setting.
Detailed description
Minor depression is one of the most common types of depressive disorders seen in primary care. The effectiveness and tolerability of antidepressants in patients with minor depression is unclear, and the development of alternative treatments is necessary.
In the first phase of this study, participants are observed for 4 weeks to identify those most in need of depression-specific treatment. Participants are then exposed to the Problem-Solving Treatment for Primary Care (PST-PC), a six-session behavioral treatment for depression. After 4 weeks, patients who do not respond adequately to the treatment are randomly assigned to either continued PST-PC or to usual care for 9 weeks. Participants are followed for 6 months after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary care patient at Dartmouth-Hitchcock Medical Center (DHMC)
- Hamilton Depression Score >= 10 and minor depression at time of entry and after 4 weeks of observation
Key exclusion criteria (3 listed)
- Psychosis, Obsessive Compulsive Disorder (OCD), or Post Traumatic Stress Disorder (PTSD)
- Active substance abuse
- Receiving treatment for depression
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 |
|---|---|---|
| Problem-Solving Treatment for Primary Care | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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?
A Phase 4 study testing Problem-Solving Treatment for Primary Care in people with Depression, run by Dartmouth-Hitchcock Medical Center 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 3 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 10 Sep 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 10 Sep 2013.