SuicideNCT01127932
Developing an Intervention to Address Suicide Risk During Substance Use Disorder
A study testing Psychoeducation for substance abuse and CBT for suicide in Substance abuse in people with Suicide and Substance-Related Disorders, run by University of Michigan at 1 site in United States.
Trial summary
This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Substance-Related Disorders
- What is being tested?
- Psychoeducation for substance abuse and CBT for suicide in Substance abuse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be over 18 years of age
- Report a past lifetime suicide attempt
- Report current suicidal ideation
- Resided in treatment for less than 4 weeks
- In treatment for less than 6 months
Who cannot join
- Mental incompetence (e.g. unable to provide informed consent)
- Diagnosis of schizophrenia or currently psychotic
Trial locations and contacts
1 site in 1 country.
About this study
This is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control condition. Through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential SUD treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.
Read the detailed description
Existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. Given the strong association between substance use and suicide, an episode of substance use disorder (SUD) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. However, there are no data on the effectiveness of specific interventions designed to decrease suicidal thoughts and behaviors during an episode of SUD treatment in individuals at high risk for suicide. Patients for this trial will be screened at the SUD treatment site for a combination of a past suicide attempt and current suicidal ideation and will be randomized to CBT or control conditions. All participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at a 3-month follow-up. From a public health perspective, SUD treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide.
- Conditions
- Suicide, Substance-Related Disorders
- Being tested
- Psychoeducation for substance abuse, CBT for suicide in Substance abuse
- Keywords
- Cognitive Behavioral Therapy
- Medical subject headings
- Suicide, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation for substance abuseBehavioural
This active control provides detailed information about substance use, suicide risk, and depression to those enrolled.
CBT for suicide in Substance abuseBehavioural
The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.
| Study group | Role | What they receive |
|---|---|---|
| CBT for suicide | Experimental | Not described Receives: Behavioral: CBT for suicide in Substance abuse |
| Enhanced care control group | Active comparator | This group is designed to be an active control which provides detailed information about substance use, suicide risk, and depression without providing any CBT or other specific therapy. Receives: Behavioral: Psychoeducation for substance abuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Suicidal Ideation
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark A. Ilgen, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127932
- Sponsor's protocol ID
- 5R21DA026925-02
- Status last verified
- May 2015
- First submitted
- 20 May 2010
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Intervention to Address Suicide Risk During Substance Use Disorder
- ClinicalTrials.gov ID
- NCT01127932
- Acronym / sponsor ID
- 5R21DA026925-02
- Conditions
- Suicide, Substance-Related Disorders
- Keywords
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 May 2010 (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 is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention to decrease suicidal thoughts and behaviors for use in Substance Use Disorder (SUD) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to an enhanced control condition. Through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential SUD treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.
Detailed description
Existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. Given the strong association between substance use and suicide, an episode of substance use disorder (SUD) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. However, there are no data on the effectiveness of specific interventions designed to decrease suicidal thoughts and behaviors during an episode of SUD treatment in individuals at high risk for suicide. Patients for this trial will be screened at the SUD treatment site for a combination of a past suicide attempt and current suicidal ideation and will be randomized to CBT or control conditions. All participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at a 3-month follow-up. From a public health perspective, SUD treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for suicide | Experimental | Behavioral: CBT for suicide in Substance abuse |
| Enhanced care control group | Active comparator | Behavioral: Psychoeducation for substance abuseThis group is designed to be an active control which provides detailed information about substance use, suicide risk, and depression without providing any CBT or other specific therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be over 18 years of age
- Report a past lifetime suicide attempt
- Report current suicidal ideation
- Resided in treatment for less than 4 weeks
- In treatment for less than 6 months
Key exclusion criteria (2 listed)
- Mental incompetence (e.g. unable to provide informed consent)
- Diagnosis of schizophrenia or currently psychotic
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 |
|---|---|---|
| Psychoeducation for substance abuseThis active control provides detailed information about substance use, suicide risk, and depression to those enrolled. | Behavioural | Enhanced care control group |
| CBT for suicide in Substance abuseThe therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts. | Behavioural | CBT for suicide |
Primary outcome
Level of Suicidal Ideation
Time frame: Six 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 13 May 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.
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 Psychoeducation for substance abuse and CBT for suicide in Substance abuse in people with Suicide and Substance-Related Disorders, run by University of Michigan 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 5 inclusion and 2 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 13 May 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.
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?
Level of Suicidal Ideation (time frame: Six 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 13 May 2015.