DepressionPhase 3NCT00052091
Therapy for Depressed Elders With Thought Problems
A Phase 3 study testing Problem Solving Therapy and Brief Supportive Therapy in people with Depression and Cognition Disorders, run by University of Washington at 2 sites in United States.
Trial summary
This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive Therapy in treating elderly patients with major depression and thought problems. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Cognition Disorders
- What is being tested?
- Problem Solving Therapy and Brief Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Mar 2008
- Phase
- Phase 3
- 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
- Nonpsychotic, unipolar major depression
- Cognitive impairment
- English speaking
Who cannot join
- High suicide risk
- Dementia
- Acute or severe medical illness
- Current psychotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California at San Francisco
San Francisco, California, 94143
Weill Medical College of Cornell University
White Plains, New York, 10605
About this study
Official title: PST in Geriatric Depression With Executive Dysfunction
This study will compare the effectiveness of Problem Solving Therapy and Brief Supportive Therapy in treating elderly patients with major depression and thought problems.
Read the detailed description
Patients who suffer from a combination of major depression and executive dysfunction symptoms often respond poorly to treatment with antidepressants. It is important, therefore, to find effective alternative therapies to treat these symptoms.
Patients are randomly assigned to receive 12 sessions (1 session/week for 12 weeks) of either PST or BST. Following treatment, patients are followed for 6 months to determine functional and clinical outcomes. Depression scales, disability scales, and scales that measure problem solving skills are used to assess patients.
- Conditions
- Depression, Cognition Disorders
- Being tested
- Problem Solving Therapy, Brief Supportive Therapy
- Keywords
- Geriatrics
- Medical subject headings
- Depression, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
A 12 week cognitive behavioral intervention for depression that teaches patients a structured approach to solving social problems.
Brief Supportive TherapyBehavioural
A 12 week intervention for depression that focuses on supporting patients attempts to cope with depression.
| Study group | Role | What they receive |
|---|---|---|
| 1 Problem Solving Therapy | Experimental | 12 weekly sessions of problem solving therapy (PST) Receives: Behavioral: Problem Solving Therapy |
| 2 Brief Supportive Therapy | Experimental | 12 weekly sessions of brief supportive therapy (BST) Receives: Behavioral: Brief Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: Measured at screening, weeks 1 through 12, and week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionMar 2008
- Study completionMar 2008
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.
- More trials run by University of WashingtonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Pat Arean, University of Washington
- Investigators
- Patricia A. Arean, PhD, Principal investigator, University of California at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052091
- Sponsor's protocol ID
- H7472-19384-8
- Other IDs
- R01MH063982, DATR A4-GPS
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2003
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Arean PA, Raue P, Mackin RS, Kanellopoulos D, McCulloch C, Alexopoulos GS. Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction. Am J Psychiatry. 2010 Nov;167(11):1391-8. doi: 10.1176/appi.ajp.2010.09091327. Epub 2010 Jun 1.
PubMed 20516155Alexopoulos GS, Raue PJ, Kiosses DN, Mackin RS, Kanellopoulos D, McCulloch C, Arean PA. Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction: effect on disability. Arch Gen Psychiatry. 2011 Jan;68(1):33-41. doi: 10.1001/archgenpsychiatry.2010.177.
PubMed 21199963Solomonov N, Kerchner D, Bein O, Lee CE, Diaz JL, Ciarleglio A, Kim S, Sirey JA, Gunning FM, Raue PJ, Banerjee S, Arean PA, Alexopoulos GS. Precision Assignment to Psychosocial Interventions for Late-Life Depression: An Automated Treatment Decision Rule. JAMA Psychiatry. 2025 Nov 1;82(11):1075-1084. doi: 10.1001/jamapsychiatry.2025.2518.
PubMed 40960814Alexopoulos GS, O'Neil R, Banerjee S, Raue PJ, Victoria LW, Bress JN, Pollari C, Arean PA. "Engage" therapy: Prediction of change of late-life major depression. J Affect Disord. 2017 Oct 15;221:192-197. doi: 10.1016/j.jad.2017.06.037. Epub 2017 Jun 19.
PubMed 28647669Gustavson KA, Alexopoulos GS, Niu GC, McCulloch C, Meade T, Arean PA. Problem-Solving Therapy Reduces Suicidal Ideation In Depressed Older Adults with Executive Dysfunction. Am J Geriatr Psychiatry. 2016 Jan;24(1):11-17. doi: 10.1016/j.jagp.2015.07.010. Epub 2015 Jul 30.
PubMed 26743100Alexopoulos GS, Raue PJ, Kiosses DN, Seirup JK, Banerjee S, Arean PA. Comparing engage with PST in late-life major depression: a preliminary report. Am J Geriatr Psychiatry. 2015 May;23(5):506-13. doi: 10.1016/j.jagp.2014.06.008. Epub 2014 Jun 26.
PubMed 25081818
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PST in Geriatric Depression With Executive Dysfunction
- ClinicalTrials.gov ID
- NCT00052091
- Acronym / sponsor ID
- H7472-19384-8
- Conditions
- Depression, Cognition Disorders
- Keywords
- Geriatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2002
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 23 Jan 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 the effectiveness of Problem Solving Therapy and Brief Supportive Therapy in treating elderly patients with major depression and thought problems.
Detailed description
Patients who suffer from a combination of major depression and executive dysfunction symptoms often respond poorly to treatment with antidepressants. It is important, therefore, to find effective alternative therapies to treat these symptoms.
Patients are randomly assigned to receive 12 sessions (1 session/week for 12 weeks) of either PST or BST. Following treatment, patients are followed for 6 months to determine functional and clinical outcomes. Depression scales, disability scales, and scales that measure problem solving skills are used to assess patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Problem Solving Therapy | Experimental | Behavioral: Problem Solving Therapy12 weekly sessions of problem solving therapy (PST) |
| 2 Brief Supportive Therapy | Experimental | Behavioral: Brief Supportive Therapy12 weekly sessions of brief supportive therapy (BST) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nonpsychotic, unipolar major depression
- Cognitive impairment
- English speaking
Key exclusion criteria (4 listed)
- High suicide risk
- Dementia
- Acute or severe medical illness
- Current psychotherapy
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 TherapyA 12 week cognitive behavioral intervention for depression that teaches patients a structured approach to solving social problems. | Behavioural | 1 Problem Solving Therapy |
| Brief Supportive TherapyA 12 week intervention for depression that focuses on supporting patients attempts to cope with depression. | Behavioural | 2 Brief Supportive Therapy |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: Measured at screening, weeks 1 through 12, and week 36
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 29 Jan 2018.
- Results publication: PubMed 20516155Arean PA, Raue P, Mackin RS, Kanellopoulos D, McCulloch C, Alexopoulos GS. Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction. Am J Psychiatry. 2010 Nov;167(11):1391-8. doi: 10.1176/appi.ajp.2010.09091327. Epub 2010 Jun 1.
- Results publication: PubMed 21199963Alexopoulos GS, Raue PJ, Kiosses DN, Mackin RS, Kanellopoulos D, McCulloch C, Arean PA. Problem-solving therapy and supportive therapy in older adults with major depression and executive dysfunction: effect on disability. Arch Gen Psychiatry. 2011 Jan;68(1):33-41. doi: 10.1001/archgenpsychiatry.2010.177.
- Derived from this study: PubMed 40960814Solomonov N, Kerchner D, Bein O, Lee CE, Diaz JL, Ciarleglio A, Kim S, Sirey JA, Gunning FM, Raue PJ, Banerjee S, Arean PA, Alexopoulos GS. Precision Assignment to Psychosocial Interventions for Late-Life Depression: An Automated Treatment Decision Rule. JAMA Psychiatry. 2025 Nov 1;82(11):1075-1084. doi: 10.1001/jamapsychiatry.2025.2518.
- Derived from this study: PubMed 28647669Alexopoulos GS, O'Neil R, Banerjee S, Raue PJ, Victoria LW, Bress JN, Pollari C, Arean PA. "Engage" therapy: Prediction of change of late-life major depression. J Affect Disord. 2017 Oct 15;221:192-197. doi: 10.1016/j.jad.2017.06.037. Epub 2017 Jun 19.
- Derived from this study: PubMed 26743100Gustavson KA, Alexopoulos GS, Niu GC, McCulloch C, Meade T, Arean PA. Problem-Solving Therapy Reduces Suicidal Ideation In Depressed Older Adults with Executive Dysfunction. Am J Geriatr Psychiatry. 2016 Jan;24(1):11-17. doi: 10.1016/j.jagp.2015.07.010. Epub 2015 Jul 30.
- Derived from this study: PubMed 25081818Alexopoulos GS, Raue PJ, Kiosses DN, Seirup JK, Banerjee S, Arean PA. Comparing engage with PST in late-life major depression: a preliminary report. Am J Geriatr Psychiatry. 2015 May;23(5):506-13. doi: 10.1016/j.jagp.2014.06.008. Epub 2014 Jun 26.
- Individual participant dataSharing planned: Yes
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
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.
Patricia A. Arean, PhD principal investigator
University of California at San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Problem Solving Therapy and Brief Supportive Therapy in people with Depression and Cognition Disorders, run by University of Washington 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 3 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 29 Jan 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Hamilton Rating Scale for Depression (time frame: Measured at screening, weeks 1 through 12, and week 36). 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 NCT00052091, 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 29 Jan 2018.