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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

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Military to Civilian Questionnaire
Secondary outcome measures
Five Facet Mindfulness Questionnaire
Generalized Anxiety Disorder Scale
Patient Health Questionnaire
+1 more

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
1,628 Previous Clinical Trials
3,325,931 Total Patients Enrolled
77 Trials studying Depression
20,685 Patients Enrolled for Depression
Sarah A Shue, PhD MS BAPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN

Media Library

RECLAIM intervention Clinical Trial Eligibility Overview. Trial Name: NCT05975008 — N/A
Depression Research Study Groups: RECLAIM intervention, Psychoeducation materials only
Depression Clinical Trial 2023: RECLAIM intervention Highlights & Side Effects. Trial Name: NCT05975008 — N/A
RECLAIM intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975008 — N/A
~6 spots leftby Aug 2024
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