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NCT02642536: MH MOVE!

Improving Obesity Self-Care Among Mentally Ill Veterans

Completed NA Results posted Last updated 22 February 2018
What this trial tests

NA trial testing MH MOVE in Anxiety in 44 participants. Completed in 31 December 2016.

Timeline
1 January 2011
Primary endpoint
31 December 2016
31 December 2016

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment44
Start date1 January 2011
Primary completion31 December 2016
Estimated completion31 December 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Anxiety or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

MOVE! Attendance Primary · 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

GroupValue95% CI
MH MOVE5.9± 1.8
Enhanced Usual Care5.8± 1.8
Number of Days Engaged in Vigorous Activity Primary · 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

GroupValue95% CI
MH MOVE21.5± 11.5
Enhanced Usual Care26.9± 18
Number of Days Engaged in Vigorous Activity Primary · 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

GroupValue95% CI
MH MOVE27.7± 22.1
Enhanced Usual Care28.1± 15.3
Self Efficacy for Practicing Good Dietary Habits Primary · 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

GroupValue95% CI
MH MOVE32.3± 19.2
Enhanced Usual Care29.8± 6.0
Self Efficacy for Practicing Good Dietary Habits Primary · 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

GroupValue95% CI
MH MOVE29.9± 10.4
Enhanced Usual Care23.2± 7.4
Assessing Depression Symptom Severity Secondary · 16 weeks

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.

GroupValue95% CI
MH MOVE6.3± 7.1
Enhanced Usual Care13.4± 6.2
Assessing Anxiety Symptom Severity Secondary · 16 weeks

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.

GroupValue95% CI
MH MOVE5.5± 6.5
Enhanced Usual Care10.5± 6.7
Assessing PTSD Symptom Severity Secondary · 16 weeks

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.

GroupValue95% CI
MH MOVE32.1± 20.8
Enhanced Usual Care53± 18
Assessing Depression Symptom Severity Secondary · baseline

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.

GroupValue95% CI
MH MOVE19± 21.7
Enhanced Usual Care15± 19.3
Assessing Anxiety Symptom Severity Secondary · baseline

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.

GroupValue95% CI
MH MOVE8± 13.8
Enhanced Usual Care16± 19.7
Assessing PTSD Symptom Severity Secondary · baseline

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.

GroupValue95% CI
MH MOVE39± 26.5
Enhanced Usual Care25± 73.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Anxiety

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02642536.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing