MDDSPARROWNCT01913366
Senior Peer Alliance for Rural Research On Wellness
A study testing CM-PST and SG-PST in people with MDD, run by University of California, San Francisco at 1 site in United States.
Trial summary
Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the University of California, San Francisco is conducting a study comparing two types of interventions for treating depression in rural older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- MDD
- What is being tested?
- CM-PST and SG-PST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 31 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residence in rural Tuolumne, Calaveras, San Joaquin or Stanislaus Counties;
- Diagnosis: Major depression, unipolar (by SCID ascertained DSM-IV criteria);
- Severity of depression: A PHQ-9>10 or a 24-Item HDRS>19;
- Need for social services: CANE score> 2, i.e. at least one unmet need;
Who cannot join
- Psychotic depression by SCID-IV, i.e., presence of delusions;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression;
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (including bipolar disorder, hypomania, and dysthymia);
- Dementia: MMSE below 24 or clinical diagnosis of dementia by DSM-IV;
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- Acute/severe medical illness (delirium, metastatic cancer, de-compensated cardiac, liver or kidney failure, stroke or myocardial infarction) 3 months prior to entry; or use of drugs causing depression, (steroids, reserpine, alphamethyl-dopa, tamoxiphen, vincristine);
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance (walking with a cane is not an exclusion criterion)
- Inability to speak English;
- Aphasia interfering with communication;
Trial locations and contacts
1 site in 1 country.
United States1 site
Catholic Charities Motherlode Office- Sonora
Sonora, California, 95370
About this study
Official title: Case Management and Problem Solving Therapy for Depressed Older Adults
Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the University of California, San Francisco is conducting a study comparing two types of interventions for treating depression in rural older adults.
Read the detailed description
If you are eligible to participate in the study after completing the screening assessment, and if you choose to continue on, we will randomize you (like a flip of a coin) to receive either 12 weeks of case management combined with problem solving therapy (CM-PST) with a social worker or 12 weeks of self-guided problem solving therapy (SG-PST) with support from a senior peer counselor.
As part of your participation in the study you will participate in three 1.5 hour assessment interviews of psychological and neuropsychological functioning (similar to your screening assessment) prior to your first week of treatment (baseline), two weeks after your final session (week 14), and three months after your final session (week 24). Additionally, you will participate in three shorter assessment interviews of psychological functioning, which will be conducted at weeks 3 and 6. These assessments will take approximately 30-45 minutes.
- Conditions
- MDD
- Being tested
- CM-PST, SG-PST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-PSTBehavioural
SG-PSTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CM-PST | Experimental | If you are assigned to CM-PST, you will be working with the same care manager from your introductory session. The care manager will continue to work with you on your problem-solving plan. Additionally, you will receive case management services. Receives: Behavioral: CM-PST |
| SG-PST | Experimental | If you are assigned to SG-PST, you will continue to work on your problem-solving plan, using the self-guided materials provided to you during the introductory session. Additionally, you will be partnered with a senior peer counselor who will support you in your SG-PST efforts. Receives: Behavioral: SG-PST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HRSD)
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Measured: Baseline
Hamilton Rating Scale for Depression (HRSD)
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Measured: Week 3
Hamilton Rating Scale for Depression (HRSD)
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Measured: Week 6
Hamilton Rating Scale for Depression (HRSD)
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Measured: Week 12
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Generic assessment instrument for health and disability
Measured: Week 0
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Generic assessment instrument for health and disability
Measured: Week 3
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Generic assessment instrument for health and disability
Measured: Week 6
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Generic assessment instrument for health and disability
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brooke Hollister, Ph.D., Principal investigator, University of California, San FranciscoPatricia Arean, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913366
- Sponsor's protocol ID
- R01AG043584-01A1
- Acronym
- SPARROW
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2013
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Management and Problem Solving Therapy for Depressed Older Adults
- ClinicalTrials.gov ID
- NCT01913366
- Acronym / sponsor ID
- SPARROW / R01AG043584-01A1
- Conditions
- MDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 1 Aug 2013 (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.
Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the University of California, San Francisco is conducting a study comparing two types of interventions for treating depression in rural older adults.
Detailed description
If you are eligible to participate in the study after completing the screening assessment, and if you choose to continue on, we will randomize you (like a flip of a coin) to receive either 12 weeks of case management combined with problem solving therapy (CM-PST) with a social worker or 12 weeks of self-guided problem solving therapy (SG-PST) with support from a senior peer counselor.
As part of your participation in the study you will participate in three 1.5 hour assessment interviews of psychological and neuropsychological functioning (similar to your screening assessment) prior to your first week of treatment (baseline), two weeks after your final session (week 14), and three months after your final session (week 24). Additionally, you will participate in three shorter assessment interviews of psychological functioning, which will be conducted at weeks 3 and 6. These assessments will take approximately 30-45 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM-PST | Experimental | Behavioral: CM-PSTIf you are assigned to CM-PST, you will be working with the same care manager from your introductory session. The care manager will continue to work with you on your problem-solving plan. Additionally, you will receive case management services. |
| SG-PST | Experimental | Behavioral: SG-PSTIf you are assigned to SG-PST, you will continue to work on your problem-solving plan, using the self-guided materials provided to you during the introductory session. Additionally, you will be partnered with a senior peer counselor who will support you in your SG-PST efforts. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Residence in rural Tuolumne, Calaveras, San Joaquin or Stanislaus Counties;
- Diagnosis: Major depression, unipolar (by SCID ascertained DSM-IV criteria);
- Severity of depression: A PHQ-9>10 or a 24-Item HDRS>19;
- Need for social services: CANE score> 2, i.e. at least one unmet need;
Key exclusion criteria (10 listed)
- Psychotic depression by SCID-IV, i.e., presence of delusions;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression;
- Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (including bipolar disorder, hypomania, and dysthymia);
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 |
|---|---|---|
| CM-PST | Behavioural | CM-PST |
| SG-PST | Behavioural | SG-PST |
Primary outcome
Hamilton Rating Scale for Depression (HRSD)
Time frame: Baseline
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Hamilton Rating Scale for Depression (HRSD)
Time frame: Week 3
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Hamilton Rating Scale for Depression (HRSD)
Time frame: Week 6
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Hamilton Rating Scale for Depression (HRSD)
Time frame: Week 12
A multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time frame: Week 0
Generic assessment instrument for health and disability
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time frame: Week 3
Generic assessment instrument for health and disability
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time frame: Week 6
Generic assessment instrument for health and disability
WHO Disability Assessment Schedule 2.0 (WHODAS-II)
Time frame: Week 12
Generic assessment instrument for health and disability
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 31 Jul 2019.
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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.
Brooke Hollister, Ph.D. principal investigator
University of California, San Francisco
Patricia Arean, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM-PST and SG-PST in people with MDD, run by University of California, San Francisco 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 10 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 31 Jul 2019. 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?
Hamilton Rating Scale for Depression (HRSD) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 31 Jul 2019.