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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
Veteran participants must be between 18-44 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

RECLAIM Trial 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.

RECLAIM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran aged between 18 and 44.

RECLAIM Trial 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

RECLAIM 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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,556 Total Patients Enrolled
76 Trials studying Depression
20,641 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: Psychoeducation materials only, RECLAIM intervention
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this medical research?

"Individuals aged between 18-44, who are clinically diagnosed with depression, can apply to this study. Currently the team is looking for 48 patients to take part in it."

Answered by AI

Is the upper age limit for this clinical research fixed at 70 years?

"This medical research seeks participants aged 18 to 44 years old. For those below the age of consent, there are 196 other trials they may participate in; for individuals 65 and older, 864 studies are available."

Answered by AI

Are recruitment efforts for this research project still active?

"According to clinicaltrials.gov, this particular trial has ceased recruitment; the initial post date was November 1st 2023 whilst the last update was on July 26th 2023. Fortunately, there are 1181 other trials actively searching for enrolment currently."

Answered by AI

Who else is applying?

What site did they apply to?
Richard L. Roudebush VA Medical Center, Indianapolis, IN
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’m tired of the up and downs of depression in my life.
PatientReceived 2+ prior treatments
~24 spots leftby Aug 2024