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Moderate Anxiety/depression: Low Intensity Stepped care for Depression (Telehealth Trial)

N/A
Waitlist Available
Led By Suzanne Danhauer, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening or baseline (if >30 days since screening), week 13
Awards & highlights

Telehealth Trial Summary

This trial is testing a stepped-care approach to reducing emotional distress and improving secondary outcomes in rural, post-treatment cancer survivors.

Eligible Conditions
  • Depression
  • Cancer
  • Anxiety
  • Sleep Disorder
  • Recurrent Disease
  • Fatigue
  • Quality of Life

Telehealth Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study screening time to end of study accrual
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of study screening time to end of study accrual for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Study Intervention Measured by Accrual Rate
Feasibility of Study Intervention Measured by Adherence to Intervention
Feasibility of Study Intervention Measured by Recruitment Rate
+1 more
Secondary outcome measures
Longitudinal Changes in the Fear of Recurrence Inventory Severity Subscale From Baseline to 13 Weeks
Longitudinal Changes in the Generalized Anxiety Disorder (GAD)-7 Score for Anxiety From Baseline to 13 Weeks
Longitudinal Changes in the Health Status Questionnaire (SF-36) From Baseline to 13 Weeks
+5 more

Telehealth Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Severe Anxiety/depression: High Intensity Stepped CareExperimental Treatment1 Intervention
Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally.
Group II: Moderate Anxiety/depression: Low Intensity Stepped careExperimental Treatment1 Intervention
participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support.
Group III: Enhanced Usual Care Control (EUC)Active Control1 Intervention
Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety & depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,169 Total Patients Enrolled
33 Trials studying Depression
32,846 Patients Enrolled for Depression
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,614 Total Patients Enrolled
81 Trials studying Depression
66,039 Patients Enrolled for Depression
Suzanne Danhauer, PhDPrincipal InvestigatorWake Forest Baptist Medical Center
3 Previous Clinical Trials
244 Total Patients Enrolled

Frequently Asked Questions

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

What are the main goals that researchers are hoping to achieve with this clinical trial?

"The key metric that will be used to determine the success of this intervention is feasibility, which will be tracked from screening to the end of the study at week 13. Additionally, changes in health status (SF-36), cancer-specific distress (IES-R), depression (PHQ-9), and anxiety (GAD-7) will be monitored longitudinally to evaluate the effectiveness of the intervention."

Answered by AI

Are there any vacancies for participants in this experiment?

"This particular clinical trial is not currently looking for patients, as indicated on clinicaltrials.gov. The study was posted on 7/19/2018 and updated last on 9/23/2022; however, there are 2396 other trials actively recruiting across the world."

Answered by AI

how many different hospitals or research centers are participating in this trial?

"This trial has 100 open slots for patients at locations such as Marshfield Medical Center-EC Cancer Center in Eau Claire, SIH Cancer Institute in Carterville, and Olathe Health Cancer Center in Olathe."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Tennessee
Wisconsin
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Pacific Central Coast Health Center-San Luis Obispo
University of New Mexico Cancer Center
Other
HaysMed University of Kansas Health System
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

One med I’m on is not working. Because I currently have depression. I've tried multiple medications and cognitive therapy.
PatientReceived no prior treatments
I suffer greatly from depression and have since middle school. I desperately would love to find something that could truly help.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is there financial compensation for this clinical trial?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Stepped-Care Telehealth for Distress in Cancer Survivors
2018. "Stepped-Care Telehealth for Distress in Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03060096.
~10 spots leftby Apr 2025
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