DepressionPhase 2NCT00012766
Effectiveness of Team Treatment of Depression in Primary Care
A Phase 2 study testing Integrated team care in people with Depression and Primary Health Care, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Primary Health Care
- What is being tested?
- Integrated team care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2001
- Phase
- Phase 2
- 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
- Several screening methods including mailed and in-clinic surveys and provider referral were used to recruit 168 team and 188 CL study patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, had primary alcohol abuse, or were too impaired to participate in the screening interview. Outcome data on the SCL-20 depression symptomatology measure, SF-36V, and Sheehan functional impairment measure were collected at baseline, 3 and 9 months.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.
Read the detailed description
Background:
Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.
Objectives:
This effectiveness study adapted collaborative care to the VA primary care setting ("collaborative care") and compared it with consult-liaison care ("CL care").
Methods:
Patients within a VA primary care clinic were randomly assigned by firm to the two interventions.
In collaborative care, existing staff resources were reorganized to form a multidisciplinary mental health specialist team. The team developed a treatment plan based on an initial assessment and suggested the plan to the primary care provider. Primary care providers' treatment efforts were then supported by brief Social Work telephone calls designed to support adherence and monitor symptomatology. Treatment results were systematically reviewed and suggestions for treatment modification were fed back to the primary providers. In CL care, the primary care providers were informed of the diagnosis and study clinicians facilitated referrals to Psychiatry residents in-clinic as requested. Mailed and in-clinic surveys and provider referral were used to recruit 168 collaborative care and 186 CL care patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, or had primary alcohol abuse. Outcome data on the SCL-20 depression symptomatology measure, Veterans SF-36, and Sheehan Disability Scale were collected at baseline, 3 and 9 months. VA utilization and costs of care were analyzed.
Status:
Complete. Final Report submitted June 30, 2001.
- Conditions
- Depression, Primary Health Care
- Being tested
- Integrated team care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated team careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Integrated team care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan C. Hedrick, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WAEdmund F. Chaney, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012766
- Sponsor's protocol ID
- IIR 95-097
- Status last verified
- Dec 2005
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hedrick SC, Chaney EF, Felker B, Liu CF, Hasenberg N, Heagerty P, Buchanan J, Bagala R, Greenberg D, Paden G, Fihn SD, Katon W. Effectiveness of collaborative care depression treatment in Veterans' Affairs primary care. J Gen Intern Med. 2003 Jan;18(1):9-16. doi: 10.1046/j.1525-1497.2003.11109.x.
PubMed 12534758Liu CF, Hedrick SC, Chaney EF, Heagerty P, Felker B, Hasenberg N, Fihn S, Katon W. Cost-effectiveness of collaborative care for depression in a primary care veteran population. Psychiatr Serv. 2003 May;54(5):698-704. doi: 10.1176/appi.ps.54.5.698.
PubMed 12719501Fischer EP, Marder SR, Smith GR, Owen RR, Rubenstein L, Hedrick SC, Curran GM. Quality Enhancement Research Initiative in Mental Health. Med Care. 2000 Jun;38(6 Suppl 1):I70-81. doi: 10.1097/00005650-200006001-00008.
PubMed 10843272Felker BL, Hedrick SC, Chaney EF, Liu CF, Heagerty P, Caples H, Lin P, Katon W. Identifying Depressed Patients With a High Risk of Comorbid Anxiety in Primary Care. Prim Care Companion J Clin Psychiatry. 2003 Jun;5(3):104-110. doi: 10.4088/pcc.v05n0301.
PubMed 15154020Lin P, Campbell DG, Chaney EF, Liu CF, Heagerty P, Felker BL, Hedrick SC. The influence of patient preference on depression treatment in primary care. Ann Behav Med. 2005 Oct;30(2):164-73. doi: 10.1207/s15324796abm3002_9.
PubMed 16173913Kanter JW, Epler AJ, Chaney EF, Liu CF, Heagerty P, Lin P, Felker B, Hedrick SC. Comparison of 3 Depression Screening Methods and Provider Referral in a Veterans Affairs Primary Care Clinic. Prim Care Companion J Clin Psychiatry. 2003 Dec;5(6):245-250. doi: 10.4088/pcc.v05n0601.
PubMed 15213794
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Team Treatment of Depression in Primary Care
- ClinicalTrials.gov ID
- NCT00012766
- Acronym / sponsor ID
- IIR 95-097
- Conditions
- Depression, Primary Health Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Mar 2001 (actual)
- First posted
- 16 Mar 2001 (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.
Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.
Detailed description
Background:
Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.
Objectives:
This effectiveness study adapted collaborative care to the VA primary care setting ("collaborative care") and compared it with consult-liaison care ("CL care").
Methods:
Patients within a VA primary care clinic were randomly assigned by firm to the two interventions.
In collaborative care, existing staff resources were reorganized to form a multidisciplinary mental health specialist team. The team developed a treatment plan based on an initial assessment and suggested the plan to the primary care provider. Primary care providers' treatment efforts were then supported by brief Social Work telephone calls designed to support adherence and monitor symptomatology. Treatment results were systematically reviewed and suggestions for treatment modification were fed back to the primary providers. In CL care, the primary care providers were informed of the diagnosis and study clinicians facilitated referrals to Psychiatry residents in-clinic as requested. Mailed and in-clinic surveys and provider referral were used to recruit 168 collaborative care and 186 CL care patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, or had primary alcohol abuse. Outcome data on the SCL-20 depression symptomatology measure, Veterans SF-36, and Sheehan Disability Scale were collected at baseline, 3 and 9 months. VA utilization and costs of care were analyzed.
Status:
Complete. Final Report submitted June 30, 2001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Integrated team care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Several screening methods including mailed and in-clinic surveys and provider referral were used to recruit 168 team and 188 CL study patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, had primary alcohol abuse, or were too impaired to participate in the screening interview. Outcome data on the SCL-20 depression symptomatology measure, SF-36V, and Sheehan functional impairment measure were collected at baseline, 3 and 9 months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Integrated team care | Behavioural | Arm 1 |
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 7 Apr 2015.
- Results publication: PubMed 12534758Hedrick SC, Chaney EF, Felker B, Liu CF, Hasenberg N, Heagerty P, Buchanan J, Bagala R, Greenberg D, Paden G, Fihn SD, Katon W. Effectiveness of collaborative care depression treatment in Veterans' Affairs primary care. J Gen Intern Med. 2003 Jan;18(1):9-16. doi: 10.1046/j.1525-1497.2003.11109.x.
- Results publication: PubMed 12719501Liu CF, Hedrick SC, Chaney EF, Heagerty P, Felker B, Hasenberg N, Fihn S, Katon W. Cost-effectiveness of collaborative care for depression in a primary care veteran population. Psychiatr Serv. 2003 May;54(5):698-704. doi: 10.1176/appi.ps.54.5.698.
- Results publication: PubMed 10843272Fischer EP, Marder SR, Smith GR, Owen RR, Rubenstein L, Hedrick SC, Curran GM. Quality Enhancement Research Initiative in Mental Health. Med Care. 2000 Jun;38(6 Suppl 1):I70-81. doi: 10.1097/00005650-200006001-00008.
- Results publication: PubMed 15154020Felker BL, Hedrick SC, Chaney EF, Liu CF, Heagerty P, Caples H, Lin P, Katon W. Identifying Depressed Patients With a High Risk of Comorbid Anxiety in Primary Care. Prim Care Companion J Clin Psychiatry. 2003 Jun;5(3):104-110. doi: 10.4088/pcc.v05n0301.
- Results publication: PubMed 16173913Lin P, Campbell DG, Chaney EF, Liu CF, Heagerty P, Felker BL, Hedrick SC. The influence of patient preference on depression treatment in primary care. Ann Behav Med. 2005 Oct;30(2):164-73. doi: 10.1207/s15324796abm3002_9.
- Results publication: PubMed 15213794Kanter JW, Epler AJ, Chaney EF, Liu CF, Heagerty P, Lin P, Felker B, Hedrick SC. Comparison of 3 Depression Screening Methods and Provider Referral in a Veterans Affairs Primary Care Clinic. Prim Care Companion J Clin Psychiatry. 2003 Dec;5(6):245-250. doi: 10.4088/pcc.v05n0601.
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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.
Susan C. Hedrick, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Edmund F. Chaney, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Integrated team care in people with Depression and Primary Health Care, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT00012766, which also lists 6 linked publications.
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 7 Apr 2015.