Suicide, AttemptedNCT01535482
Cognitive Therapy for Suicidal Older Men
A study testing Cognitive Therapy in people with Suicide, Attempted, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. Read more about this study
- Who is it for?
- Ages 50 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
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 6 Apr 2017
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suicidal intent or desire during the past month prior to the baseline interview as indicated by a score of 1 or higher on items 4 or 5 of the Scale for Suicide Ideation.
- Male
- 50 years of age or older
- Able to speak English
- Able to provide written informed consent
- Able to attend study assessment and therapy sessions
- Able to provide at least two verifiable contacts for tracking purposes
- Able to function at an intellectual level to allow for the reliable completion of study assessments and participate in psychotherapy as indicated by a Mini-Mental Status Exam (MMSE) total score of 24 or higher and an Executive Interview (EXIT-25) total score of 14 or lower.
Who cannot join
- Needed priority treatment for a substance use disorder as determined by the referring clinician.
- Needed priority treatment for PTSD as determined by the referring clinician.
- Taking antidepressant medication for less than one month, or if antidepressant medication has been changed in the last month as indicated by the Alexopolous "Composite Antidepressant Score" Scale.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aaron T. Beck Psychopathology Research Center - University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. The investigators expect that suicidal older men randomly assigned to the CT intervention condition will have a lower rate of SI during the follow-up period than participants assigned to the control condition.
Read the detailed description
Older adult males have the highest suicide rate of any age group in the U.S. 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 50 and above. This study will assess the effectiveness of specialized cognitive therapy versus enhanced usual care in treating older men with suicide ideation.
Participants in this five-year study will be randomly assigned to receive either cognitive therapy or enhanced usual care. Participants will be identified within the VA Medical Center and the University of Pennsylvania Health System (UPHS) 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 enhanced usual 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. In addition, patients in the enhanced usual care condition will receive weekly telephone calls from the study therapists. These phone calls will be approximately 15-30 minutes in duration and their purpose will be to ensure patient safety and to provide some support. 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, 9, and 12 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.
- Conditions
- Suicide, Attempted
- Being tested
- Cognitive Therapy, Enhanced Usual Care
- Keywords
- Cognitive therapy, Suicide, Older men, suicide ideation
- 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
Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
Enhanced Usual CareBehavioural
Enhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy | Experimental | A cognitive therapy protocol specifically designed to target suicidal ideation in older adults. Receives: Behavioral: Cognitive Therapy |
| Enhanced Usual Care | Active comparator | Enhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline suicidal ideation
Measured: baseline, 1, 3, 6, 9, 12 months
Secondary outcomes (8)
depression
Measured: baseline, 1, 3, 6, 9, 12 months
hopelessness
Measured: baseline, 1, 3, 6, 9, 12 months
quality of life
Measured: baseline, 1, 3, 6, 9, 12 months
social problem solving skills
Measured: baseline, 1, 3, 6, 9, 12 months
complicated grief
Measured: baseline, 1, 3, 6, 9, 12 months
reasons for living and dying
Measured: baseline, 1, 3, 6, 9, 12 months
perceived social support
Measured: baseline, 1, 3, 6, 9, 12 months
Cognitive Executive Functioning
Executive functioning will be measured by scores on an Executive Functioning Interview, which measures skills such as planning, working memory, attention, inhibition, and mental flexibility.
Measured: baseline, 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startSep 2011
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535482
- Sponsor's protocol ID
- R01MH086572-01A2
- Other IDs
- 1R01MH086572-01A2
- Status last verified
- Jun 2017
- First submitted
- 25 Aug 2011
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Therapy for Suicidal Older Men
- ClinicalTrials.gov ID
- NCT01535482
- Acronym / sponsor ID
- R01MH086572-01A2
- Conditions
- Suicide, Attempted
- Keywords
- Cognitive therapy, Suicide, Older men, suicide ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2011
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 17 Feb 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.
The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. The investigators expect that suicidal older men randomly assigned to the CT intervention condition will have a lower rate of SI during the follow-up period than participants assigned to the control condition.
Detailed description
Older adult males have the highest suicide rate of any age group in the U.S. 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 50 and above. This study will assess the effectiveness of specialized cognitive therapy versus enhanced usual care in treating older men with suicide ideation.
Participants in this five-year study will be randomly assigned to receive either cognitive therapy or enhanced usual care. Participants will be identified within the VA Medical Center and the University of Pennsylvania Health System (UPHS) 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 enhanced usual 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. In addition, patients in the enhanced usual care condition will receive weekly telephone calls from the study therapists. These phone calls will be approximately 15-30 minutes in duration and their purpose will be to ensure patient safety and to provide some support. 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, 9, and 12 to assess suicide ideation. Self-report and clinician-administered measures will be used to assess participants' progress.
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 | Experimental | Behavioral: Cognitive TherapyA cognitive therapy protocol specifically designed to target suicidal ideation in older adults. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareEnhanced usual care consists of the usual care that individuals receive for suicide prevention, plus assessment and referral services provided by project staff, and weekly phone calls provided by study therapists. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Suicidal intent or desire during the past month prior to the baseline interview as indicated by a score of 1 or higher on items 4 or 5 of the Scale for Suicide Ideation.
- Male
- 50 years of age or older
- Able to speak English
- Able to provide written informed consent
Key exclusion criteria (3 listed)
- Needed priority treatment for a substance use disorder as determined by the referring clinician.
- Needed priority treatment for PTSD as determined by the referring clinician.
- Taking antidepressant medication for less than one month, or if antidepressant medication has been changed in the last month as indicated by the Alexopolous "Composite Antidepressant Score" Scale.
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 TherapyCognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions. | Behavioural | Cognitive Therapy |
| Enhanced Usual CareEnhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support. | Behavioural | Enhanced Usual Care |
Primary outcome
Change in baseline suicidal ideation
Time frame: baseline, 1, 3, 6, 9, 12 months
8 secondary outcomes
depression
Time frame: baseline, 1, 3, 6, 9, 12 months
hopelessness
Time frame: baseline, 1, 3, 6, 9, 12 months
quality of life
Time frame: baseline, 1, 3, 6, 9, 12 months
social problem solving skills
Time frame: baseline, 1, 3, 6, 9, 12 months
complicated grief
Time frame: baseline, 1, 3, 6, 9, 12 months
reasons for living and dying
Time frame: baseline, 1, 3, 6, 9, 12 months
perceived social support
Time frame: baseline, 1, 3, 6, 9, 12 months
Cognitive Executive Functioning
Time frame: baseline, 1, 3, 6, 9, 12 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 Jun 2017.
Related trials for Suicide, Attempted
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Active, not recruiting
DBT Skills Groups for Veterans at High Risk for Suicide Attempt
Suicide, Attempted
Active, not recruiting
Cognitive Reappraisal Intervention for Suicide Prevention (CRISP 70+) for Suicidal Older Adults in a Swedish Geropsychiatric Setting
Suicidal Ideation, Suicide
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A 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 8 inclusion and 3 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 Jun 2017. 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?
Change in baseline suicidal ideation (time frame: baseline, 1, 3, 6, 9, 12 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 Jun 2017.