Major DepressionNCT01566318
Depression Agency-Based Collaboration
A study testing Problem-Solving Therapy in people with Major Depression and Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depression, Anxiety Disorder
- What is being tested?
- Problem-Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2016
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age => 60 years
- Modified Mini Mental State (3MS) Examination =>80
- Receiving aging services or difficulty with 1+ ADL/IADL
- PHQ-9 score > 0 and <= 9 (and question 1 or 2 is >0)
Who cannot join
- Major depressive episode or anxiety disorder within 12 mo
- Ever diagnosed with bipolar disorder or schizophrenia
- Drug or alcohol use disorder within the past 12 months
- Currently taking antidepressants
- Currently taking antianxiety med >4x/week for past 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Depression Agency-Based Collaborative (Depression ABC)
Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. This 3-year research uses a randomized controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent depression in seniors receiving aging services.
Read the detailed description
The research will determine (i) if a course of problem solving therapy (PST) and Brief Behavioral Therapy for Insomnia (BBTI), with boosters, reduces incidence of major depressive episodes over 12 months relative to usual care, and (ii) the extent to which behavioral therapies achieve these effects through enhancement of protective factors, such as greater self-efficacy, better targeting of services to address needs, and greater control over home environments.
Periodic blood draws will be used to assess biosignatures of depression. Guiding our investigations of pharmacogenetics, inflammation, and proteomics are synergistic interactions among the serotonergic system, the HPA axis, systemic inflammation, growth factors such as brain derived neuro-trophic factor (BDNF), psychosocial stressors, and vascular co-morbidity. Genetic variation in vasopressin receptors, potentially involved in both cardiovascular risk and social attachment, is also associated with recurrence of depression. Similarly, genetic variation in inflammation may influence antidepressant response and medical co-morbidity.
- Conditions
- Major Depression, Anxiety Disorder
- Being tested
- Problem-Solving Therapy
- Keywords
- Depression, Anxiety, Geriatric mental health
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving TherapyBehavioural
6-8 sessions over 8 weeks, with booster
| Study group | Role | What they receive |
|---|---|---|
| Problem solving therapy (PST) | Experimental | 6-8 sessions of PST, with booster, delivered over 8 weeks Receives: Behavioral: Problem-Solving Therapy |
| Usual care | No intervention | Usual agency care, monitored for mental health services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major depressive disorder
Patient Health Questionnaire score > 9 with confirming diagnostic interview
Measured: 12 months
Generalized anxiety disorder
Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2016
- Study completionJun 2016
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.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Steven M. Albert, University of Pittsburgh
- Investigators
- Steven M Albert, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566318
- Sponsor's protocol ID
- P30MH090333-PRC1
- Other IDs
- P30MH090333
- Status last verified
- Dec 2016
- First submitted
- 27 Mar 2012
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van Hout HP, van der Horst HE, Cuijpers P, Smit F, Beekman AT. Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):297-304. doi: 10.1001/archgenpsychiatry.2008.555.
PubMed 19255379
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Agency-Based Collaborative (Depression ABC)
- ClinicalTrials.gov ID
- NCT01566318
- Acronym / sponsor ID
- P30MH090333-PRC1
- Conditions
- Major Depression, Anxiety Disorder
- Keywords
- Depression, Anxiety, Geriatric mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Mar 2012 (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.
Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. This 3-year research uses a randomized controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem solving therapy [PST] and Brief Behavioral Therapy for Insomnia [BBTI]) to prevent depression in seniors receiving aging services.
Detailed description
The research will determine (i) if a course of problem solving therapy (PST) and Brief Behavioral Therapy for Insomnia (BBTI), with boosters, reduces incidence of major depressive episodes over 12 months relative to usual care, and (ii) the extent to which behavioral therapies achieve these effects through enhancement of protective factors, such as greater self-efficacy, better targeting of services to address needs, and greater control over home environments.
Periodic blood draws will be used to assess biosignatures of depression. Guiding our investigations of pharmacogenetics, inflammation, and proteomics are synergistic interactions among the serotonergic system, the HPA axis, systemic inflammation, growth factors such as brain derived neuro-trophic factor (BDNF), psychosocial stressors, and vascular co-morbidity. Genetic variation in vasopressin receptors, potentially involved in both cardiovascular risk and social attachment, is also associated with recurrence of depression. Similarly, genetic variation in inflammation may influence antidepressant response and medical co-morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem solving therapy (PST) | Experimental | Behavioral: Problem-Solving Therapy6-8 sessions of PST, with booster, delivered over 8 weeks |
| Usual care | No intervention | –Usual agency care, monitored for mental health services |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age => 60 years
- Modified Mini Mental State (3MS) Examination =>80
- Receiving aging services or difficulty with 1+ ADL/IADL
- PHQ-9 score > 0 and <= 9 (and question 1 or 2 is >0)
Key exclusion criteria (5 listed)
- Major depressive episode or anxiety disorder within 12 mo
- Ever diagnosed with bipolar disorder or schizophrenia
- Drug or alcohol use disorder within the past 12 months
- Currently taking antidepressants
- Currently taking antianxiety med >4x/week for past 4 weeks
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 Therapy6-8 sessions over 8 weeks, with booster | Behavioural | Problem solving therapy (PST) |
Primary outcome
Major depressive disorder
Time frame: 12 months
Patient Health Questionnaire score > 9 with confirming diagnostic interview
Generalized anxiety disorder
Time frame: 12 months
Generalized anxiety disorder score >=10, and meets criteria for SCID or PRIME-MD diagnosis
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 13 Dec 2016.
- Background: PubMed 19255379van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van Hout HP, van der Horst HE, Cuijpers P, Smit F, Beekman AT. Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):297-304. doi: 10.1001/archgenpsychiatry.2008.555.
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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.
Steven M Albert, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Therapy in people with Major Depression and Anxiety Disorder, run by University of Pittsburgh 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 4 inclusion and 5 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 13 Dec 2016. 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?
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?
Major depressive disorder (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01566318, 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 13 Dec 2016.