Suicide, AttemptedPhase 1NCT00149773
Cognitive Therapy for Suicidal Older Men in Primary Care Settings
A Phase 1 study testing Cognitive Therapy in people with Suicide, Attempted, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will assess the effectiveness of cognitive therapy in reducing the incidence of suicide ideation and behavior in older men in a primary care setting. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Feb 2011
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently experiencing death ideation or suicidal ideation (total score greater than 0 on the Scale for Suicide Ideation)
- English-speaking
- Lives within the area served by the research unit
- Able to provide at least 2 verifiable contacts (typically family members)
Who cannot join
- Requires priority treatment for an acute, unstable, or severe Axis III disorder (e.g., dementia)
- Requires priority treatment for another debilitating problem (e.g., severe alcohol or drug dependence, mania, severe anorexia)
- Suffers from a psychotic disorder or psychotic thought processes
- Exhibits self-mutilating behavior without any intent to commit suicide (e.g., burning oneself with a cigarette)
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychopathology Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study will assess the effectiveness of cognitive therapy in reducing the incidence of suicide ideation and behavior in older men in a primary care setting.
Read the detailed description
Older adult males have the highest suicide rate of any age group in the U.S. Over 70 percent of older suicide victims have been to their primary care physician within a month of their death, many with a depressive illness that was not detected. However, most research concerning treatments for suicide ideation and behavior has focused on adolescents and young adults. Very few treatments have been developed to reduce suicide ideation and behavior in men aged 60 and above. This study will assess the effectiveness of specialized cognitive therapy versus typical treatment in treating older men with suicide ideation.
Participants in this two-year, single-blind study will be randomly assigned to receive either cognitive therapy combined with enriched care or enriched care alone. Participants will be identified in primary care settings as having experienced suicide ideation in the past month. Cognitive therapy will be provided by Ph.D.-level therapists and will be geared specifically toward older men with suicidal tendencies. The enriched care condition will consist of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by independent evaluators and study case managers. All participants will be assessed pre-treatment to attain baseline measures of suicide ideation, hopelessness, and depression. Study visits will occur at baseline and Months 1, 3, 6, 12, 18, and 24 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00218725
- Conditions
- Suicide, Attempted
- Being tested
- Cognitive Therapy
- Keywords
- Cognitive therapy, Suicide, Older men, Death ideation, Primary care
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy + Enriched Usual Care | Experimental | The cognitive therapy intervention consists of approximately 12 (1-hour) sessions over the course of a 4-month period. The main therapy components include:
1. Using problem-solving and cognitive restructuring techniques to target hopelessness, reasons for living and dying, coping with loss, and perceived medical comorbidity that lead to suicidal ideation.
2. Improving social resources.
3. Improving adherence to medical regimen.
4. Targeting Suicidal Cognitions. Receives: Behavioral: Cognitive Therapy |
| EnrichedUsual Care Condition | No intervention | The Enriched Care (EC) condition will be used as the treatment comparison for this study. EC consists of usual care patients may obtain in the community as well as the assessment and referral services provided by the study case managers. Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health treatment in the community. The primary role of the study case manager is to establish a strong relationship with patients in order to retain the patients in the study for the duration of the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24
Measured: 1, 3, 6, 12, 18, and 24 months
Secondary outcomes (3)
Depression; measured at Months 1, 3, 6, 12, 18, and 24
Measured: 1, 3, 6, 12, 18, and 24 months
Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24
Measured: 1, 3, 6, 12, 18, and 24 months
Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24
Measured: 1, 3, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2008
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Aaron T. Beck, MD, Principal investigator, University of PennsylvaniaGregory K. Brown, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149773
- Sponsor's protocol ID
- P20MH071905-01
- Other IDs
- P20MH071905-01, 802223, DSIR 83-ATP
- Status last verified
- Jun 2006
- First submitted
- 6 Sep 2005
- Last updated
- 8 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Therapy for Suicidal Older Men in Primary Care Settings
- ClinicalTrials.gov ID
- NCT00149773
- Acronym / sponsor ID
- P20MH071905-01
- Conditions
- Suicide, Attempted
- Keywords
- Cognitive therapy, Suicide, Older men, Death ideation, Primary care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Sep 2005 (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 assess the effectiveness of cognitive therapy in reducing the incidence of suicide ideation and behavior in older men in a primary care setting.
Detailed description
Older adult males have the highest suicide rate of any age group in the U.S. Over 70 percent of older suicide victims have been to their primary care physician within a month of their death, many with a depressive illness that was not detected. However, most research concerning treatments for suicide ideation and behavior has focused on adolescents and young adults. Very few treatments have been developed to reduce suicide ideation and behavior in men aged 60 and above. This study will assess the effectiveness of specialized cognitive therapy versus typical treatment in treating older men with suicide ideation.
Participants in this two-year, single-blind study will be randomly assigned to receive either cognitive therapy combined with enriched care or enriched care alone. Participants will be identified in primary care settings as having experienced suicide ideation in the past month. Cognitive therapy will be provided by Ph.D.-level therapists and will be geared specifically toward older men with suicidal tendencies. The enriched care condition will consist of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by independent evaluators and study case managers. All participants will be assessed pre-treatment to attain baseline measures of suicide ideation, hopelessness, and depression. Study visits will occur at baseline and Months 1, 3, 6, 12, 18, and 24 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00218725
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy + Enriched Usual Care | Experimental | Behavioral: Cognitive TherapyThe cognitive therapy intervention consists of approximately 12 (1-hour) sessions over the course of a 4-month period. The main therapy components include: 1. Using problem-solving and cognitive restructuring techniques to target hopelessness, reasons for living and dying, coping with loss, and perceived medical comorbidity that lead to suicidal ideation. 2. Improving social resources. 3. Improving adherence to medical regimen. 4. Targeting Suicidal Cognitions. |
| EnrichedUsual Care Condition | No intervention | –The Enriched Care (EC) condition will be used as the treatment comparison for this study. EC consists of usual care patients may obtain in the community as well as the assessment and referral services provided by the study case managers. Participation in the study does not restrict patients in any way in their access to other health care, and all patients in both conditions will be allowed to receive any additional mental health treatment in the community. The primary role of the study case manager is to establish a strong relationship with patients in order to retain the patients in the study for the duration of the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently experiencing death ideation or suicidal ideation (total score greater than 0 on the Scale for Suicide Ideation)
- English-speaking
- Lives within the area served by the research unit
- Able to provide at least 2 verifiable contacts (typically family members)
Key exclusion criteria (4 listed)
- Requires priority treatment for an acute, unstable, or severe Axis III disorder (e.g., dementia)
- Requires priority treatment for another debilitating problem (e.g., severe alcohol or drug dependence, mania, severe anorexia)
- Suffers from a psychotic disorder or psychotic thought processes
- Exhibits self-mutilating behavior without any intent to commit suicide (e.g., burning oneself with a cigarette)
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 |
|---|---|---|
| Cognitive Therapy | Behavioural | Cognitive Therapy + Enriched Usual Care |
Primary outcome
Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24
Time frame: 1, 3, 6, 12, 18, and 24 months
3 secondary outcomes
Depression; measured at Months 1, 3, 6, 12, 18, and 24
Time frame: 1, 3, 6, 12, 18, and 24 months
Hopelessness; measured at Months 1, 3, 6, 12, 18, and 24
Time frame: 1, 3, 6, 12, 18, and 24 months
Perceived Social Support; measured at Months 1, 3, 6, 12, 18, and 24
Time frame: 1, 3, 6, 12, 18, and 24 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 Apr 2015.
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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.
Aaron T. Beck, MD principal investigator
University of Pennsylvania
Gregory K. Brown, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive Therapy in people with Suicide, Attempted, run by University of Pennsylvania 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 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 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 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?
Suicidal Ideation; measured at Months 1, 3, 6, 12, 18, and 24 (time frame: 1, 3, 6, 12, 18, and 24 months). 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 8 Apr 2015.