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Virtual Mindfulness-Based Intervention for Depression (RECLAIM Trial)
N/A
Recruiting
Led By Sarah A Shue, PhD MS BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if mindfulness can help Veterans reduce depression & better adjust to life after service.
Who is the study for?
This trial is for Veterans enrolled in VHA care, aged 18-44, who served after October 2001 and are experiencing difficulty adjusting to civilian life. They must also have moderate depression as indicated by a score of 10-14 on the PHQ-9.
What is being tested?
The study tests 'RECLAIM', a virtual mindfulness-based program designed to ease depressive symptoms and help Veterans reintegrate into civilian life more smoothly.
What are the potential side effects?
Since this intervention involves mindfulness practices rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or distress during the process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Military to Civilian Questionnaire
Secondary study objectives
Five Facet Mindfulness Questionnaire
Generalized Anxiety Disorder Scale
Patient Health Questionnaire
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RECLAIM interventionExperimental Treatment1 Intervention
Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
Group II: Psychoeducation materials onlyActive Control1 Intervention
We will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,761 Total Patients Enrolled
78 Trials studying Depression
19,930 Patients Enrolled for Depression
Sarah A Shue, PhD MS BAPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran aged between 18 and 44.I am a veteran and have some difficulty adjusting to civilian life.
Research Study Groups:
This trial has the following groups:- Group 1: RECLAIM intervention
- Group 2: Psychoeducation materials only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.