Suicide and Self-harmNCT03682406
CAMS-G Group Therapy for Suicidal Veterans
A study testing CAMS-G in people with Suicide and Self-harm, run by Louisville VA Medical Center at 1 site in United States.
Trial summary
The primary aim of this pilot study is to determine the feasibility and acceptability of CAMS-G. Our aim is to determine if CAMS-G is an effective treatment and whether it has the potential to be tested in a large-scale setting. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Suicide and Self-harm
- What is being tested?
- CAMS-G
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Apr 2022
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18-89 years old
- Endorses suicidality (acknowledges recent/current suicidal thoughts, plans, and/or behavior and wish to work on it clinically).
- Veteran is willing to engage in treatment around the suicidality.
- Eligible to receive care at the Robley Rex VA Medical Center
- English speaking based on the need to participate in group treatment
Who cannot join
- CAMS-G is designed to be as broadly inclusive as possible. On a case-by-case basis, psychopathology and/or cognitive limitations that significantly interfere with the patient's ability to interact effectively and/or benefit from a group intervention could preclude the patient from participating in the group.
- A Veteran could be excluded if he or she has a circumstance that could be harmful to other members who are already in the group (e.g., we will not enroll a sex offender who is working on that issue into a group with a victim of sexual abuse).
- A Veteran who is unwilling to meaningfully engage in treatment (e.g., unwilling to reduce access to lethal means, directly address suicidal drivers, engage in collaborative treatment planning, develop a safety plan, participate in group discussion, etc.) is inappropriate for participation in the group on an outpatient basis.
- Veterans will be excluded if they have previously been in a CAMS-G treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Collaborative Assessment and Management of Suicidality - Group (CAMS-G)
The primary aim of this pilot study is to determine the feasibility and acceptability of CAMS-G. Our aim is to determine if CAMS-G is an effective treatment and whether it has the potential to be tested in a large-scale setting.
Read the detailed description
A total of 60 patients from either the Robley Rex VAMC inpatient psychiatry unit or outpatient clinics will be enrolled in the study. If the Veteran is referred from inpatient psychiatry, study staff will meet with the Veteran to determine eligibility and consent the Veterans on the inpatient unit prior to discharge. A phone interview will be scheduled to complete the baseline interview after the Veteran has been discharged from the inpatient psychiatry unit. Outpatient referrals will be handled similarly. Whenever possible, to reduce participant burden, the study team will meet Veterans at a community based outpatient clinic (CBOC) to consent outpatients either immediately prior to or after a scheduled appointment. A phone interview will be scheduled to complete the baseline prior to the start of their group. Patients will then be randomized to either (a) an experimental group receiving CAMS-G or (b) a group receiving care as usual. All study participants will then complete telephone follow-up assessments at 1-, 3-, and 6-month time points administered by members of the research team. Dr. Gutierrez and his study team will rate the CAMS-G sessions for adherence to the treatment manual. Individual Veterans remain in the CAMS-G sessions until their suicidal crisis is resolved. The baseline assessment battery will take approximately 60 minutes and the 1-, 3-, and 6-month assessment batteries will take approximately 45 minutes.
The Client Satisfaction Questionnaire will be administered at three- and six-month follow-up for each study participant. This will allow reflection on the acceptability and perceived utility of CAMS-G. Notes will be kept on patients who decided to drop out of the intervention and/or the study. The outcome of this aim is evidence that the final CAMS-G manual and study procedures that would be used in an efficacy trial are acceptable to participants. The investigators will examine the mean and standard deviation for the total score and individual items to determine if study participants report acceptable ratings of satisfaction. The investigators will review the responses to open ended questions regarding what Veterans perceived as being helpful about their group experience and what they could do in the future if they become suicidal.
The investigators will tabulate average scores and standard deviations for the overall rating and each individual item on the CAMS-G Rating Scale to determine whether the facilitators maintained fidelity to the treatment manual over the course of the study.
The investigators will tally the different services received by study participants in order to accurately describe what care as usual consisted of for all study participants, regardless of their assigned treatment condition. This will also the investigators to control for any major differences in care as usual between treatment conditions, for example more individual psychotherapy for one condition, when examining between group differences on outcomes of interest.
At the termination of data collection, the investigators will complete a data cleansing process. Descriptive statistics for demographic and clinical variables will be tabulated. All scales will be scored and subscales described. This process will include examining the data for missing values, appropriate ranges, and outliers, with transformations to skewed data applied as needed. Although the randomization design should ensure balance between the two groups, it is essential to control for any known confounders in the design and analysis to prevent a biased assessment of the suicide assessment effect. Any baseline demographic or clinical variables found to be statistically significant in the analysis and significantly associated with the outcomes of interest will be included as covariates in all analytic models.
Dropouts and missing data. The investigators will use an intent-to-treat sample to complete our analyses. That is, all participants who provide consent, are randomized to a treatment condition, and attend at least one group therapy session will be included in the analyses regardless of whether they drop out or complete a full course of group therapy. To understand whether treatment drops were completely random, random, or informative, the investigators will analyze our missing data and adjust our interpretation of the results accordingly. The investigators will use generalized linear mixed models (GLMM) to measure differences at 1-, 3-, and 6-months follow-up between veterans in the CAMS-G treatment condition and those in the control treatment condition on constructs of Hopelessness, Thwarted Belongingness, Perceived Burdensomeness, Overall Symptom Distress, and Reasons for Living. The investigators will use Poisson or similar variant of generlized linear mixed modeling (GLMM) for skewed and count data to measure differences at 1-, 3-, and 6-months follow-up between Veterans in the CAMS-G treatment condition and those in the control treatment condition on severity of suicidal ideation and incidence of self-directed violence.
- Conditions
- Suicide and Self-harm
- Being tested
- CAMS-G
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMS-GBehavioural
Group-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality.
| Study group | Role | What they receive |
|---|---|---|
| CAMS-G | Experimental | CAMS-G is an group-based adaptation of the Collaborative Assessment and Management of Suicidality (CAMS) that has been developed to address perceived burdensomeness and thwarted belongingness, two drivers of suicide risk. Ongoing assessment and treatment planning are completed using the CAMS Suicide Status Form in the group modality, with involvement from group members and group facilitators. Driver-focused intervention strategies and group process also occur in the group based upon the unique needs of the group members. Groups are 90-minutes in length and occur on a weekly basis. Receives: Behavioral: CAMS-G |
| Care as Usual | Other | Care as usual includes access to all existing forms of treatment that currently exist at the Robley Rex VAMC and affiliated CBOCs, such as individual and group psychotherapy, suicide prevention programming and case management, psychiatric care, social work services, and substance use disorder counseling. We will essentially track the control condition over time as they engage in the typical services provided to suicidal Veterans through the Robley Rex VAMC. The CAMS-G study participants will have access to the same services delivered as part of care as usual, with the only difference being their participation in the CAMS-G treatment for suicidality. Receives: Behavioral: CAMS-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Harm Behavior Questionnaire
Self-report measure composed of four sections, each assessing different facets of suicidality. Each subsection will be scored for occurrence and severity, including non-suicidal self-injury, suicide attempts, suicide threats, and suicidal ideation.
Measured: 6 months
Changes Beck Scale for Suicidal Ideation
19-item assessment used to evaluate the current intensity of the patient's specific attitudes toward, behavior, and plans to commit suicide. Total score will be reported which ranges from 0 (no suicidal ideation) to 38 (high suicidal ideation)
Measured: 6 months
Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness
12-item measure of the extent to which individuals feel connected to others (i.e., belongingness) and like a burden on people in their lives (i.e., perceived burdensomeness). Subscale total scores for thwarted belongingness and perceived burdensomeness will be reported. For thwarted belongingness, scores range from 9 (low) to 63 (high). For perceived burdensomeness, scores range from 6 (low) to 42 (high).
Measured: 6 months
Changes in Beck Hopelessness Scale
20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents over the previous week. Scores range from 0 to 20 representing nil (0-3), mild (4-8), moderate (9-14), and severe (> 14) levels of hopelessness.
Measured: 6 months
Changes in Reasons for Living Inventory
48-item measure that rates the importance of different reasons why people choose not to kill themselves. Total score will be reported, which ranges from 48 (low reasons for living) to 288 (High reasons for living).
Measured: 6 months
Changes in Outcome Questionnaire-45
45-item tracking/assessment instrument measuring overall symptom distress, which ranges from 0 (low distress) to 180 (high distress)
Measured: 6 months
Changes in Optimism and Hope Scale
14-item self-report measure combining a measure of dispositional optimism and trait hopefulness, with scores ranging from 0 (low) to 42 (high)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Oct 2018
- Primary completion28 Dec 2019
- Study completion1 Apr 2022
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 and Self-harmStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be assigned in even numbers to CAMS-G or care as usual.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisville VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Rocky Mountain MIRECC for Suicide Prevention
- Responsible party
- Principal investigator, Lora Johnson, Louisville VA Medical Center
- Investigators
- Eleanor Lederer, MD, Study chair, Louisville VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682406
- Sponsor's protocol ID
- 00467
- Status last verified
- Apr 2022
- First submitted
- 21 Sep 2018
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gutierrez PM, Johnson L, Podlogar MC, Hagman S, Muehler TA, Hanson J, Pierson JT, Brown AA, O'Connor S. Pilot study of the Collaborative Assessment and Management of Suicidality-Group. Suicide Life Threat Behav. 2022 Apr;52(2):244-255. doi: 10.1111/sltb.12817. Epub 2021 Nov 15.
PubMed 34780099
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Collaborative Assessment and Management of Suicidality - Group (CAMS-G)
- ClinicalTrials.gov ID
- NCT03682406
- Acronym / sponsor ID
- 00467
- Conditions
- Suicide and Self-harm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Louisville VA Medical CenterUS federal agency
- Collaborators
- Rocky Mountain MIRECC for Suicide Prevention
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 24 Sep 2018 (actual)
- 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 this pilot study is to determine the feasibility and acceptability of CAMS-G. Our aim is to determine if CAMS-G is an effective treatment and whether it has the potential to be tested in a large-scale setting.
Detailed description
A total of 60 patients from either the Robley Rex VAMC inpatient psychiatry unit or outpatient clinics will be enrolled in the study. If the Veteran is referred from inpatient psychiatry, study staff will meet with the Veteran to determine eligibility and consent the Veterans on the inpatient unit prior to discharge. A phone interview will be scheduled to complete the baseline interview after the Veteran has been discharged from the inpatient psychiatry unit. Outpatient referrals will be handled similarly. Whenever possible, to reduce participant burden, the study team will meet Veterans at a community based outpatient clinic (CBOC) to consent outpatients either immediately prior to or after a scheduled appointment. A phone interview will be scheduled to complete the baseline prior to the start of their group. Patients will then be randomized to either (a) an experimental group receiving CAMS-G or (b) a group receiving care as usual. All study participants will then complete telephone follow-up assessments at 1-, 3-, and 6-month time points administered by members of the research team. Dr. Gutierrez and his study team will rate the CAMS-G sessions for adherence to the treatment manual. Individual Veterans remain in the CAMS-G sessions until their suicidal crisis is resolved. The baseline assessment battery will take approximately 60 minutes and the 1-, 3-, and 6-month assessment batteries will take approximately 45 minutes.
The Client Satisfaction Questionnaire will be administered at three- and six-month follow-up for each study participant. This will allow reflection on the acceptability and perceived utility of CAMS-G. Notes will be kept on patients who decided to drop out of the intervention and/or the study. The outcome of this aim is evidence that the final CAMS-G manual and study procedures that would be used in an efficacy trial are acceptable to participants. The investigators will examine the mean and standard deviation for the total score and individual items to determine if study participants report acceptable ratings of satisfaction. The investigators will review the responses to open ended questions regarding what Veterans perceived as being helpful about their group experience and what they could do in the future if they become suicidal.
The investigators will tabulate average scores and standard deviations for the overall rating and each individual item on the CAMS-G Rating Scale to determine whether the facilitators maintained fidelity to the treatment manual over the course of the study.
The investigators will tally the different services received by study participants in order to accurately describe what care as usual consisted of for all study participants, regardless of their assigned treatment condition. This will also the investigators to control for any major differences in care as usual between treatment conditions, for example more individual psychotherapy for one condition, when examining between group differences on outcomes of interest.
At the termination of data collection, the investigators will complete a data cleansing process. Descriptive statistics for demographic and clinical variables will be tabulated. All scales will be scored and subscales described. This process will include examining the data for missing values, appropriate ranges, and outliers, with transformations to skewed data applied as needed. Although the randomization design should ensure balance between the two groups, it is essential to control for any known confounders in the design and analysis to prevent a biased assessment of the suicide assessment effect. Any baseline demographic or clinical variables found to be statistically significant in the analysis and significantly associated with the outcomes of interest will be included as covariates in all analytic models.
Dropouts and missing data. The investigators will use an intent-to-treat sample to complete our analyses. That is, all participants who provide consent, are randomized to a treatment condition, and attend at least one group therapy session will be included in the analyses regardless of whether they drop out or complete a full course of group therapy. To understand whether treatment drops were completely random, random, or informative, the investigators will analyze our missing data and adjust our interpretation of the results accordingly. The investigators will use generalized linear mixed models (GLMM) to measure differences at 1-, 3-, and 6-months follow-up between veterans in the CAMS-G treatment condition and those in the control treatment condition on constructs of Hopelessness, Thwarted Belongingness, Perceived Burdensomeness, Overall Symptom Distress, and Reasons for Living. The investigators will use Poisson or similar variant of generlized linear mixed modeling (GLMM) for skewed and count data to measure differences at 1-, 3-, and 6-months follow-up between Veterans in the CAMS-G treatment condition and those in the control treatment condition on severity of suicidal ideation and incidence of self-directed violence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in even numbers to CAMS-G or care as usual.
| Arm | Type | Receives |
|---|---|---|
| CAMS-G | Experimental | Behavioral: CAMS-GCAMS-G is an group-based adaptation of the Collaborative Assessment and Management of Suicidality (CAMS) that has been developed to address perceived burdensomeness and thwarted belongingness, two drivers of suicide risk. Ongoing assessment and treatment planning are completed using the CAMS Suicide Status Form in the group modality, with involvement from group members and group facilitators. Driver-focused intervention strategies and group process also occur in the group based upon the unique needs of the group members. Groups are 90-minutes in length and occur on a weekly basis. |
| Care as Usual | Other | Behavioral: CAMS-GCare as usual includes access to all existing forms of treatment that currently exist at the Robley Rex VAMC and affiliated CBOCs, such as individual and group psychotherapy, suicide prevention programming and case management, psychiatric care, social work services, and substance use disorder counseling. We will essentially track the control condition over time as they engage in the typical services provided to suicidal Veterans through the Robley Rex VAMC. The CAMS-G study participants will have access to the same services delivered as part of care as usual, with the only difference being their participation in the CAMS-G treatment for suicidality. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult 18-89 years old
- Endorses suicidality (acknowledges recent/current suicidal thoughts, plans, and/or behavior and wish to work on it clinically).
- Veteran is willing to engage in treatment around the suicidality.
- Eligible to receive care at the Robley Rex VA Medical Center
- English speaking based on the need to participate in group treatment
Key exclusion criteria (4 listed)
- CAMS-G is designed to be as broadly inclusive as possible. On a case-by-case basis, psychopathology and/or cognitive limitations that significantly interfere with the patient's ability to interact effectively and/or benefit from a group intervention could preclude the patient from participating in the group.
- A Veteran could be excluded if he or she has a circumstance that could be harmful to other members who are already in the group (e.g., we will not enroll a sex offender who is working on that issue into a group with a victim of sexual abuse).
- A Veteran who is unwilling to meaningfully engage in treatment (e.g., unwilling to reduce access to lethal means, directly address suicidal drivers, engage in collaborative treatment planning, develop a safety plan, participate in group discussion, etc.) is inappropriate for participation in the group on an outpatient basis.
- Veterans will be excluded if they have previously been in a CAMS-G treatment
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 |
|---|---|---|
| CAMS-GGroup-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality. | Behavioural | CAMS-G, Care as Usual |
Primary outcome
Self-Harm Behavior Questionnaire
Time frame: 6 months
Self-report measure composed of four sections, each assessing different facets of suicidality. Each subsection will be scored for occurrence and severity, including non-suicidal self-injury, suicide attempts, suicide threats, and suicidal ideation.
Changes Beck Scale for Suicidal Ideation
Time frame: 6 months
19-item assessment used to evaluate the current intensity of the patient's specific attitudes toward, behavior, and plans to commit suicide. Total score will be reported which ranges from 0 (no suicidal ideation) to 38 (high suicidal ideation)
Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness
Time frame: 6 months
12-item measure of the extent to which individuals feel connected to others (i.e., belongingness) and like a burden on people in their lives (i.e., perceived burdensomeness). Subscale total scores for thwarted belongingness and perceived burdensomeness will be reported. For thwarted belongingness, scores range from 9 (low) to 63 (high). For perceived burdensomeness, scores range from 6 (low) to 42 (high).
Changes in Beck Hopelessness Scale
Time frame: 6 months
20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents over the previous week. Scores range from 0 to 20 representing nil (0-3), mild (4-8), moderate (9-14), and severe (> 14) levels of hopelessness.
Changes in Reasons for Living Inventory
Time frame: 6 months
48-item measure that rates the importance of different reasons why people choose not to kill themselves. Total score will be reported, which ranges from 48 (low reasons for living) to 288 (High reasons for living).
Changes in Outcome Questionnaire-45
Time frame: 6 months
45-item tracking/assessment instrument measuring overall symptom distress, which ranges from 0 (low distress) to 180 (high distress)
Changes in Optimism and Hope Scale
Time frame: 6 months
14-item self-report measure combining a measure of dispositional optimism and trait hopefulness, with scores ranging from 0 (low) to 42 (high)
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 21 Apr 2022.
- Results publication: PubMed 34780099Gutierrez PM, Johnson L, Podlogar MC, Hagman S, Muehler TA, Hanson J, Pierson JT, Brown AA, O'Connor S. Pilot study of the Collaborative Assessment and Management of Suicidality-Group. Suicide Life Threat Behav. 2022 Apr;52(2):244-255. doi: 10.1111/sltb.12817. Epub 2021 Nov 15.
- Individual participant dataSharing planned: No
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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.
Eleanor Lederer, MD study chair
Louisville VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMS-G in people with Suicide and Self-harm, run by Louisville VA Medical Center 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 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 21 Apr 2022. 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?
Self-Harm Behavior Questionnaire (time frame: 6 months). The study lists 7 primary outcomes in all. 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 NCT03682406, 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 21 Apr 2022.