Suicide, AttemptedPhase 1NCT00218725
Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
A Phase 1 study testing Cognitive Therapy and Enriched Care in people with Suicide, Attempted and Substance-Related Disorders, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will examine the effectiveness of combining cognitive therapy with enriched usual care for preventing subsequent suicide attempts in people with a drug dependence who have recently attempted suicide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Substance-Related Disorders
- What is being tested?
- Cognitive Therapy and Enriched Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Oct 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent suicide attempt with an emergency department visit within 48 hours of the attempt (suicide attempt is considered to be a potentially self-injurious behavior with a nonfatal outcome for which there is evidence, either explicit or implicit, that the individual intended to kill himself or herself)
- Current DSM-IV diagnosis of a current drug dependence disorder within the past 6 months
Who cannot join
- Self-mutilating behavior without intent to commit suicide
- An acute, unstable, or severe Axis III disorder that may affect participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychopathology Research Unit-University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
This study will examine the effectiveness of combining cognitive therapy with enriched usual care for preventing subsequent suicide attempts in people with a drug dependence who have recently attempted suicide.
Read the detailed description
Suicide attempts involving drug abuse are a major public health problem. Development of interventions that focus on reducing the suicide attempt rate among drug abusers is a necessity. There is a strong connection between drug abuse and both suicide attempts and completed suicide. As much as 45% of drug abusers have attempted suicide at least once. The rate of completed suicide among drug abusers has been reported to be as much as 30 times the rate for the general population. Unfortunately, there is a lack of empirically supported treatments for reducing suicidal behavior in drug abusers. This study will develop and evaluate the effectiveness of a cognitive therapy intervention for people with a drug dependence disorder who recently attempted suicide.
Participants in this single-blind study will be randomly assigned to one of two treatment groups: cognitive therapy combined with enriched usual care; or enriched usual care alone. An initial baseline assessment will occur within 7 days following the participant's suicide attempt and subsequent medical evaluation at a hospital emergency department. Suicide behavior and ideation, depression, hopelessness, and addiction severity will be assessed. Following the baseline assessment, treatment will begin. The cognitive therapy treatment will be specifically developed to prevent suicide attempts. It will involve the identification of proximal thoughts, images, and core beliefs that were activated prior to the suicide attempt. Cognitive and behavioral strategies will be applied to address the identified thoughts and beliefs. Patients will also learn adaptive ways of coping with stressors. The enriched usual care will entail standard treatments for suicide prevention. Study visits will occur 1, 3, 6, 12, 18, and 24 months following enrollment. Baseline measurements will be repeated at each study visit to evaluate participants' improvement. Participants receiving cognitive therapy will attend approximately 10 weekly or bi-weekly outpatient study visits. Participation will last for 2 years.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00149773
- Conditions
- Suicide, Attempted, Substance-Related Disorders
- Being tested
- Cognitive Therapy, Enriched Care
- Keywords
- Cognitive Therapy, Suicide, Addictions, Substance Abuse
- Medical subject headings
- Suicide, Attempted, Substance-Related Disorders, Suicide, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis.
Enriched CareOther
Also called Case Management
The Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the 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 and substance abuse treatment in the community.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy | Other | The cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis. Receives: Behavioral: Cognitive Therapy |
| Enriched Care | Other | The Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the 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 and substance abuse treatment in the community. Receives: Other: Enriched Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Attempts
Measured: Months 1, 3, 6, 12, 18, and 24
Secondary outcomes (4)
Suicide Ideation
Measured: Months 1, 3, 6, 12, 18, and 24
Depression
Measured: Months 1, 3, 6, 12, 18, and 24
Hopelessness
Measured: Months 1, 3, 6, 12, 18, and 24
Substance Use
Measured: Months 1, 3, 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 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
- NCT00218725
- Sponsor's protocol ID
- P20MH071905-02
- Other IDs
- P20MH071905-02, 802439, FWA00003616, DSIR 83-ATP
- Status last verified
- Sep 2015
- First submitted
- 21 Sep 2005
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Witt 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 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder
- ClinicalTrials.gov ID
- NCT00218725
- Acronym / sponsor ID
- P20MH071905-02
- Conditions
- Suicide, Attempted, Substance-Related Disorders
- Keywords
- Cognitive Therapy, Suicide, Addictions, Substance Abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 22 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 examine the effectiveness of combining cognitive therapy with enriched usual care for preventing subsequent suicide attempts in people with a drug dependence who have recently attempted suicide.
Detailed description
Suicide attempts involving drug abuse are a major public health problem. Development of interventions that focus on reducing the suicide attempt rate among drug abusers is a necessity. There is a strong connection between drug abuse and both suicide attempts and completed suicide. As much as 45% of drug abusers have attempted suicide at least once. The rate of completed suicide among drug abusers has been reported to be as much as 30 times the rate for the general population. Unfortunately, there is a lack of empirically supported treatments for reducing suicidal behavior in drug abusers. This study will develop and evaluate the effectiveness of a cognitive therapy intervention for people with a drug dependence disorder who recently attempted suicide.
Participants in this single-blind study will be randomly assigned to one of two treatment groups: cognitive therapy combined with enriched usual care; or enriched usual care alone. An initial baseline assessment will occur within 7 days following the participant's suicide attempt and subsequent medical evaluation at a hospital emergency department. Suicide behavior and ideation, depression, hopelessness, and addiction severity will be assessed. Following the baseline assessment, treatment will begin. The cognitive therapy treatment will be specifically developed to prevent suicide attempts. It will involve the identification of proximal thoughts, images, and core beliefs that were activated prior to the suicide attempt. Cognitive and behavioral strategies will be applied to address the identified thoughts and beliefs. Patients will also learn adaptive ways of coping with stressors. The enriched usual care will entail standard treatments for suicide prevention. Study visits will occur 1, 3, 6, 12, 18, and 24 months following enrollment. Baseline measurements will be repeated at each study visit to evaluate participants' improvement. Participants receiving cognitive therapy will attend approximately 10 weekly or bi-weekly outpatient study visits. Participation will last for 2 years.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00149773
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 | Other | Behavioral: Cognitive TherapyThe cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis. |
| Enriched Care | Other | Other: Enriched CareThe Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the 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 and substance abuse treatment in the community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recent suicide attempt with an emergency department visit within 48 hours of the attempt (suicide attempt is considered to be a potentially self-injurious behavior with a nonfatal outcome for which there is evidence, either explicit or implicit, that the individual intended to kill himself or herself)
- Current DSM-IV diagnosis of a current drug dependence disorder within the past 6 months
Key exclusion criteria (2 listed)
- Self-mutilating behavior without intent to commit suicide
- An acute, unstable, or severe Axis III disorder that may affect participation
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 TherapyThe cognitive therapy intervention for suicide attempters has been designed to provide a brief, timely, flexible intervention that can be incorporated into general and psychiatric inpatient and outpatient services and applied to the population of patients who attempt suicide. A central feature of the intervention is the adaptation of cognitive therapy to the population of patients who attempt suicide. The focus of the intervention is the identification of core beliefs and key automatic thoughts that were elicited prior to and during the most recent suicide attempt. Once these beliefs and thoughts have been articulated, the counselor and patient develop more adaptive responses during an acute suicidal crisis. | Behavioural | Cognitive Therapy |
| Enriched CareAlso: Case ManagementThe Enriched Care condition will be used as the treatment comparison condition for this study. The Enriched Care condition consists of the usual care that patients may obtain in the community as well as the assessment and referral services provided by the 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 and substance abuse treatment in the community. | Other | Enriched Care |
Primary outcome
Suicidal Attempts
Time frame: Months 1, 3, 6, 12, 18, and 24
4 secondary outcomes
Suicide Ideation
Time frame: Months 1, 3, 6, 12, 18, and 24
Depression
Time frame: Months 1, 3, 6, 12, 18, and 24
Hopelessness
Time frame: Months 1, 3, 6, 12, 18, and 24
Substance Use
Time frame: Months 1, 3, 6, 12, 18, and 24
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 Sep 2015.
- 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.
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 and Enriched Care in people with Suicide, Attempted and Substance-Related Disorders, 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 2 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 29 Sep 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 Attempts (time frame: Months 1, 3, 6, 12, 18, and 24). 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 NCT00218725, which also lists 1 linked publication.
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 Sep 2015.