AnxietyMH MOVE!NCT02642536
Improving Obesity Self-Care Among Mentally Ill Veterans
A study testing MH MOVE in people with Anxiety and Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, PTSD
- What is being tested?
- MH MOVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2011to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Anxiety, Depression, PTSD, Obesity
- Being tested
- MH MOVE, Enhanced Usual Care
- Keywords
- Veteran
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MH MOVEBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: MH MOVE |
| 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 16 weeks
Secondary outcomes (6)
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.
Measured: 16 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start1 Jan 2011
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gina Evans, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642536
- Sponsor's protocol ID
- D7886-W
- Acronym
- MH MOVE!
- Status last verified
- Jan 2018
- First submitted
- 10 Dec 2015
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Obesity Self-care Among Mentally Ill Veterans
- ClinicalTrials.gov ID
- NCT02642536
- Acronym / sponsor ID
- MH MOVE! / D7886-W
- Conditions
- Anxiety, Depression, PTSD, Obesity
- Keywords
- Veteran
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MH MOVE | Active comparator | Behavioral: MH MOVEprovides 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 | Behavioral: Enhanced Usual Careprovides 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| MH MOVEprovides 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 | Behavioural | MH MOVE |
| Enhanced Usual Careprovides 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. | Behavioural | Enhanced Usual Care |
Primary outcome
MOVE! Attendance
Time frame: 16 weeks
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
Number of Days Engaged in Vigorous Activity
Time frame: 16 weeks
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
Number of Days Engaged in Vigorous Activity
Time frame: baseline
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
Self Efficacy for Practicing Good Dietary Habits
Time frame: baseline
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
Self Efficacy for Practicing Good Dietary Habits
Time frame: 16 weeks
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
6 secondary outcomes
Assessing Depression Symptom Severity
Time frame: 16 weeks
Assessing Anxiety Symptom Severity
Time frame: 16 weeks
Assessing PTSD Symptom Severity
Time frame: 16 weeks
Assessing Depression Symptom Severity
Time frame: baseline
Assessing Anxiety Symptom Severity
Time frame: baseline
Assessing PTSD Symptom Severity
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Gina Evans, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MH MOVE in people with Anxiety and Depression, run by VA Office of Research and Development 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 4 inclusion and 7 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 22 Feb 2018. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MOVE! Attendance (time frame: 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.