Improving Obesity Self-Care Among Mentally Ill Veterans
Status: | Completed |
---|---|
Conditions: | Anxiety, Anxiety, Depression, Obesity Weight Loss, Psychiatric |
Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/24/2018 |
Start Date: | January 1, 2011 |
End Date: | December 31, 2016 |
Improving Obesity Self-care Among Mentally Ill Veterans
The purpose of this study is to find out which of two programs, MH MOVE! or the enhanced
usual care MOVE! program is most effective in improving participation in and completion of
MOVE! among Veterans with depression, anxiety, and PTSD. One of the treatments, MH MOVE!
provides the standard MOVE! weight management program plus a workbook containing education
for management of depression, anxiety and PTSD symptoms to be used during 10 phone based
clinician led CBT sessions. The enhanced usual care MOVE! provides the standard MOVE! weight
management program plus a workbook containing education for management of depression, anxiety
and PTSD symptoms but not phone calls are provided.
usual care MOVE! program is most effective in improving participation in and completion of
MOVE! among Veterans with depression, anxiety, and PTSD. One of the treatments, MH MOVE!
provides the standard MOVE! weight management program plus a workbook containing education
for management of depression, anxiety and PTSD symptoms to be used during 10 phone based
clinician led CBT sessions. The enhanced usual care MOVE! provides the standard MOVE! weight
management program plus a workbook containing education for management of depression, anxiety
and PTSD symptoms but not phone calls are provided.
First-time, newly enrolled participants in the MOVE! program will be targeted for treatment.
Recruitment will take place utilizing flyers and MEDVAMC clinician referral. The research
coordinator, PI or other study staff will attend the MOVE! assessment group and individual
MOVE! sessions. During this initial contact, a recruitment letter will be read to all
potential subjects. The letter will provide an overview of the study and allow potential
participants the opportunity to express interest in the study. Those who are interested will
be invited to sign their name to a sheet indicating their interest in the study and their
willingness to undergo the initial screening for eligibility. In order to determine
eligibility, patient records will be accessed for inclusion and exclusion information.
Veterans who meet the inclusion criteria will be contacted to schedule a time to sign the
necessary consent forms and receive the pre-treatment screening assessment forms. The
pre-treatment assessment will be conducted face to face and last approximately 1 hour. During
this time, the research coordinator or other study staff will review the VA consent, VA
10-3203 consent to voice recording, and VA HIPPA forms and answer any additional questions.
After all questions regarding consent and study enrollment are answered, the RC or other
study staff will instruct the participant to sign the consent forms. The participants will
receive hard copies of the VA consent, VA 10-3203 consent to voice recording, and VA HIPPA
forms that contain all required signatures. The Veteran will then be provided the intake
assessment forms. These forms will gather demographic data such as age, gender, ethnicity,
race, education, marital status, employment, VA disability, and military history. Veterans
will be asked about medications, other therapies, and hospitalizations. Additional screening
assessments will measure mental health diagnosis and symptom severity. Veterans who continue
to meet the inclusion criteria will then be included into the study. Veterans who do not meet
the inclusion criteria but demonstrate a need or ask for additional services from the MEDVAMC
will be referred for mental health care. In the randomized controlled trial, once Veterans
have been consented, they will be randomized to the MH MOVE or enhanced usual-care MOVE!
treatment group. Those who are randomized to the MH MOVE! group will be administered the 6
core, 2 optional, and 2 booster depression, anxiety and PTSD focused MH MOVE! treatment
module sessions via phone.
Recruitment will take place utilizing flyers and MEDVAMC clinician referral. The research
coordinator, PI or other study staff will attend the MOVE! assessment group and individual
MOVE! sessions. During this initial contact, a recruitment letter will be read to all
potential subjects. The letter will provide an overview of the study and allow potential
participants the opportunity to express interest in the study. Those who are interested will
be invited to sign their name to a sheet indicating their interest in the study and their
willingness to undergo the initial screening for eligibility. In order to determine
eligibility, patient records will be accessed for inclusion and exclusion information.
Veterans who meet the inclusion criteria will be contacted to schedule a time to sign the
necessary consent forms and receive the pre-treatment screening assessment forms. The
pre-treatment assessment will be conducted face to face and last approximately 1 hour. During
this time, the research coordinator or other study staff will review the VA consent, VA
10-3203 consent to voice recording, and VA HIPPA forms and answer any additional questions.
After all questions regarding consent and study enrollment are answered, the RC or other
study staff will instruct the participant to sign the consent forms. The participants will
receive hard copies of the VA consent, VA 10-3203 consent to voice recording, and VA HIPPA
forms that contain all required signatures. The Veteran will then be provided the intake
assessment forms. These forms will gather demographic data such as age, gender, ethnicity,
race, education, marital status, employment, VA disability, and military history. Veterans
will be asked about medications, other therapies, and hospitalizations. Additional screening
assessments will measure mental health diagnosis and symptom severity. Veterans who continue
to meet the inclusion criteria will then be included into the study. Veterans who do not meet
the inclusion criteria but demonstrate a need or ask for additional services from the MEDVAMC
will be referred for mental health care. In the randomized controlled trial, once Veterans
have been consented, they will be randomized to the MH MOVE or enhanced usual-care MOVE!
treatment group. Those who are randomized to the MH MOVE! group will be administered the 6
core, 2 optional, and 2 booster depression, anxiety and PTSD focused MH MOVE! treatment
module sessions via phone.
Inclusion Criteria:
- Eligible participants will be Veterans over 18 years of age who are overweight or
obese as indicated by a BMI greater than 30.
- Participants who are enrolled have never participated in the MOVE! program and are
joining the MOVE! program for the first time.
- Severity of potential co-existing anxiety and depression will be assessed by a
diagnosis of PTSD, anxiety and depression noted in the medical history and will be
confirmed using the PTSD Checklist (PCL-C), Patient Health Questionnaire (PHQ-8),
Generalized Anxiety 7-item Scale (GAD-7).
- Participants who endorse mild-to-moderate depression characterized by a scores in the
range of 5-19 on the PHQ-8, scores ranging from 5-14 on the GAD-7 scale and scores
6-50 on the PCL.
Exclusion Criteria:
- Participants will be excluded if they have a medical diagnosis of schizophrenia or
bi-polar
- Have symptom checklist score in the severe range of anxiety, depression or PTSD
- Demonstrate suicidal/homicidal plan and intent
- And/or demonstrate moderate or severe cognitive impairment as demonstrated by the
cognitive status screener
- Do not have regular access to a telephone
- Are no longer obese as established by calculation of current BMI
- Or are no longer endorsing any symptoms of anxiety or depression as established by a
score of less than 5 (due to lack of depressive symptoms) and those greater than 19
(due to severity of depressive symptoms) on the PHQ-8 and less than 5 (indicating no
presence of anxiety) and greater than 15 (indicating severe anxiety) on the GAD-7 less
than 6 (indicating no presence of PTSD symptoms) and greater than 50 (severe PTSD) on
the PCL.
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