Major DepressionPhase 1NCT00541957
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
A Phase 1 study testing behavior therapy and Medication prescribed by PCP in people with Major Depression, run by Butler Hospital at 2 sites in United States.
Trial summary
This is a pilot study. The purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depression
- What is being tested?
- behavior therapy and Medication prescribed by PCP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Jan 2010
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current MDD or MDD within the past year or current dysthymia
- PHQ-9 > 10
- have been prescribed an antidepressant medication (by their PCP) at least 8 weeks before pre-treatment timepoint
- are able to speak, read, and understand English sufficiently well to complete study procedures
- are between the ages of 18 and 70
Who cannot join
- presence of significant suicidal ideation or risk
- history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year;
- history of antisocial personality disorder or borderline personality disorder;
- currently in psychotherapy or have received counseling more frequently than once per month in the past year.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Hospital of RI
Pawtucket, Rhode Island, 02860
Butler Hospital
Providence, Rhode Island, 02906
About this study
This is a pilot study. The purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients.
- Conditions
- Major Depression
- Being tested
- behavior therapy, Medication prescribed by PCP
- Keywords
- Major depression, Primary care
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavior therapyBehavioural
10 sessions over 4 months
Medication prescribed by PCPDrug
Can include any antidepressant medication
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Medication prescribed by PCP Receives: Drug: Medication prescribed by PCP |
| 1 | Experimental | Medication prescribed by PCP + behavior therapy Receives: Behavioral: behavior therapy; Drug: Medication prescribed by PCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Measured: 4 months
Secondary outcomes (1)
Psychosocial functioning
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hospital of Rhode Island
- Investigators
- Lisa Uebelacker, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541957
- Sponsor's protocol ID
- K23MH067779
- Status last verified
- Jul 2011
- First submitted
- 8 Oct 2007
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Uebelacker LA, German NM, Gaudiano BA, Miller IW. Patient health questionnaire depression scale as a suicide screening instrument in depressed primary care patients: a cross-sectional study. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01027. doi: 10.4088/PCC.10m01027.
PubMed 21731830
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
- ClinicalTrials.gov ID
- NCT00541957
- Acronym / sponsor ID
- K23MH067779
- Conditions
- Major Depression
- Keywords
- Major depression, Primary care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Memorial Hospital of Rhode Island
- Study start
- Apr 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Oct 2007 (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 is a pilot study. The purpose of this study is to determine whether adding 4 months of behavioral therapy to primary care physician medication treatment(relative to medication treatment alone) improves outcomes for persistently depressed primary care patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Drug: Medication prescribed by PCPMedication prescribed by PCP |
| 1 | Experimental | Behavioral: behavior therapy, Drug: Medication prescribed by PCPMedication prescribed by PCP + behavior therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current MDD or MDD within the past year or current dysthymia
- PHQ-9 > 10
- have been prescribed an antidepressant medication (by their PCP) at least 8 weeks before pre-treatment timepoint
- are able to speak, read, and understand English sufficiently well to complete study procedures
- are between the ages of 18 and 70
Key exclusion criteria (4 listed)
- presence of significant suicidal ideation or risk
- history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year;
- history of antisocial personality disorder or borderline personality disorder;
- currently in psychotherapy or have received counseling more frequently than once per month in the past year.
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 |
|---|---|---|
| behavior therapy10 sessions over 4 months | Behavioural | 1 |
| Medication prescribed by PCPCan include any antidepressant medication | Drug | 1, 2 |
Primary outcome
Depression symptoms
Time frame: 4 months
1 secondary outcome
Psychosocial functioning
Time frame: 4 months
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 8 Jul 2011.
- Derived from this study: PubMed 21731830Uebelacker LA, German NM, Gaudiano BA, Miller IW. Patient health questionnaire depression scale as a suicide screening instrument in depressed primary care patients: a cross-sectional study. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01027. doi: 10.4088/PCC.10m01027.
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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.
Lisa Uebelacker, PhD principal investigator
Butler Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing behavior therapy and Medication prescribed by PCP in people with Major Depression, run by Butler Hospital at 2 sites 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 5 inclusion and 4 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 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Depression symptoms (time frame: 4 months). 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 NCT00541957, 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 8 Jul 2011.