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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MH MOVE | Active Comparator | 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 |
|
| Enhanced Usual Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MH MOVE | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MOVE! Attendance | Number of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item | 16 weeks |
| Number of Days Engaged in Vigorous Activity | changes in vigor and time spent on physical activity practice will be measured by the MOVE! 11 assessment at post treatment (16 weeks) minimum-maximum total score range (0-48) Higher value represents more days spent performing vigorous activity | 16 weeks |
| Number of Days Engaged in Vigorous Activity | Initial assessment of vigor and time spent on physical activity minimum-maximum total score range (0-32) Higher value represents more days spent performing vigorous physical activity The score was obtained from a single item | baseline |
| Self Efficacy for Practicing Good Dietary Habits | Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales | baseline |
| Self Efficacy for Practicing Good Dietary Habits | Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing Depression Symptom Severity | Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure. | 16 weeks |
| Assessing Anxiety Symptom Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina Evans, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| FG001 | Enhanced Usual Care | 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. Enhanced Usual Care: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 8 phone based clinician led CBT sessions 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 8 phone based clinician led CBT sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MOVE! Attendance | Number of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item | Posted | Mean | Standard Deviation | number of sessions | 16 weeks |
|
Adverse events data was collected during the entire 2 year study time frame.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 8 phone based clinician led CBT sessions 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 8 phone based clinician led CBT sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gina Evans | VA | 713-440-4459 | gina.evans@va.gov |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
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Masking was Double Blind
| Enhanced Usual Care | Behavioral | 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. |
|
Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure. |
| 16 weeks |
| Assessing PTSD Symptom Severity | PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales. | 16 weeks |
| Assessing Depression Symptom Severity | Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure. | baseline |
| Assessing Anxiety Symptom Severity | Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure. | baseline |
| Assessing PTSD Symptom Severity | PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales. | baseline |
| BG001 | Enhanced Usual Care | 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. Enhanced Usual Care: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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.
Enhanced Usual Care: 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.
|
|
| Primary | Number of Days Engaged in Vigorous Activity | changes in vigor and time spent on physical activity practice will be measured by the MOVE! 11 assessment at post treatment (16 weeks) minimum-maximum total score range (0-48) Higher value represents more days spent performing vigorous activity | Posted | Mean | Standard Deviation | days spent performing vigorous activity | 16 weeks |
|
|
|
| Primary | Number of Days Engaged in Vigorous Activity | Initial assessment of vigor and time spent on physical activity minimum-maximum total score range (0-32) Higher value represents more days spent performing vigorous physical activity The score was obtained from a single item | Posted | Mean | Standard Deviation | days spent performing vigorous activity | baseline |
|
|
|
| Primary | Self Efficacy for Practicing Good Dietary Habits | Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
| Primary | Self Efficacy for Practicing Good Dietary Habits | Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Secondary | Assessing Depression Symptom Severity | Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure. | frequency analysis | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Secondary | Assessing Anxiety Symptom Severity | Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Secondary | Assessing PTSD Symptom Severity | PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Secondary | Assessing Depression Symptom Severity | Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure. | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
| Secondary | Assessing Anxiety Symptom Severity | Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure. | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
| Secondary | Assessing PTSD Symptom Severity | PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales. | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
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|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Enhanced Usual Care | 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. Enhanced Usual Care: 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D000068099 |
| Trauma and Stressor Related Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |