CAMS-G Group Therapy for Suicidal Veterans
Status: | Recruiting |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 89 |
Updated: | 3/2/2019 |
Start Date: | October 1, 2018 |
End Date: | March 28, 2019 |
Contact: | Lora L Johnson, PhD |
Email: | Lora.Johnson2@va.gov |
Phone: | 502-287-4011 |
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.
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.
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.
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.
Inclusion Criteria:
1. Adult 18-89 years old
2. Endorses suicidality (acknowledges recent/current suicidal thoughts, plans, and/or
behavior and wish to work on it clinically).
3. Veteran is willing to engage in treatment around the suicidality.
4. Eligible to receive care at the Robley Rex VA Medical Center
5. English speaking based on the need to participate in group treatment
Exclusion Criteria:
1. 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.
2. 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).
3. 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.
4. Veterans will be excluded if they have previously been in a CAMS-G treatment
We found this trial at
1
site
Louisville, Kentucky 40202
Principal Investigator: Lora L Johnson, PhD
Phone: 502-287-4011
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