Suicide, AttemptedPhase 3NCT00081367
Community-Based Cognitive Therapy for Suicide Attempters
A Phase 3 study testing CBT in people with Suicide, Attempted, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Nov 2009
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suicide attempt within 48 hours prior to being evaluated at the hospital
- English speaking
- Able to provide 2 verifiable contacts
Who cannot join
- Acute, unstable, or severe Axis III disorder or a severe Axis I disorder that may prevent safe participation in outpatient psychotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.
Read the detailed description
Rates of mental health and substance use disorders are high among economically disadvantaged, ethnic minority populations. Studies have shown that CBT designed for this high-risk population is successful at reducing suicide attempts in people with suicidal thoughts or attempts. This study will implement a CBT intervention into the community and will focus on increasing compliance with psychiatric, substance abuse, and medical treatment.
Participants in this study will be randomly assigned to receive either CBT plus standard care or standard care alone. Participants who receive CBT will have ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed. Assessments will be made 1, 3, 6, 12, 18, and 24 months after study completion.
- Conditions
- Suicide, Attempted
- Being tested
- CBT, Standard care alone
- Keywords
- Minority Groups
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Participants will receive ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed.
Standard care aloneBehavioural
Participants will receive standard care for suicide prevention.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy (CBT) + standard care | Experimental | Participants will receive ten weekly sessions of treatment plus standard care for suicide prevention. Receives: Behavioral: CBT; Behavioral: Standard care alone |
| Standard care alone | Active comparator | Participants will receive standard care for suicide prevention. Receives: Behavioral: Standard care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat suicide attempts
Measured: Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study startFeb 2004
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 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
- Principal investigator, Gregory Brown, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081367
- Sponsor's protocol ID
- R01MH067805
- Other IDs
- R01MH067805, DSIR 83-ATP
- Status last verified
- Jun 2014
- First submitted
- 9 Apr 2004
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
PubMed 16077050Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Cognitive Therapy for Suicide Attempters
- ClinicalTrials.gov ID
- NCT00081367
- Acronym / sponsor ID
- R01MH067805
- Conditions
- Suicide, Attempted
- Keywords
- Minority Groups
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Apr 2004 (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 determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.
Detailed description
Rates of mental health and substance use disorders are high among economically disadvantaged, ethnic minority populations. Studies have shown that CBT designed for this high-risk population is successful at reducing suicide attempts in people with suicidal thoughts or attempts. This study will implement a CBT intervention into the community and will focus on increasing compliance with psychiatric, substance abuse, and medical treatment.
Participants in this study will be randomly assigned to receive either CBT plus standard care or standard care alone. Participants who receive CBT will have ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed. Assessments will be made 1, 3, 6, 12, 18, and 24 months after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT) + standard care | Experimental | Behavioral: CBT, Behavioral: Standard care aloneParticipants will receive ten weekly sessions of treatment plus standard care for suicide prevention. |
| Standard care alone | Active comparator | Behavioral: Standard care aloneParticipants will receive standard care for suicide prevention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Suicide attempt within 48 hours prior to being evaluated at the hospital
- English speaking
- Able to provide 2 verifiable contacts
Key exclusion criteria (1 listed)
- Acute, unstable, or severe Axis III disorder or a severe Axis I disorder that may prevent safe participation in outpatient 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 |
|---|---|---|
| CBTParticipants will receive ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed. | Behavioural | Cognitive behavioral therapy (CBT) + standard care |
| Standard care aloneParticipants will receive standard care for suicide prevention. | Behavioural | Cognitive behavioral therapy (CBT) + standard care, Standard care alone |
Primary outcome
Repeat suicide attempts
Time frame: Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion
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 10 Jun 2014.
- Background: PubMed 16077050Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
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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.
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 Phase 3 study testing CBT 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 3 inclusion and 1 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 10 Jun 2014. 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 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?
Repeat suicide attempts (time frame: Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion). 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 NCT00081367, which also lists 2 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 10 Jun 2014.