- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286305
Media and Mental Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brent Gary
- Phone Number: (520) 626-8000
- Email: bgary@arizona.edu
Study Contact Backup
- Name: Karen Weihs, MD, MD
- Phone Number: 520-626-8940
- Email: weihs@psychiatry.arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- Recruiting
- University of Arizona
-
Contact:
- Karen Weihs, MD
- Phone Number: 520-626-8940
- Email: weihs@psychiatry.arizona.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18years old
- Recipient of treatment at WHC for at least 6 months.
- English speaking
Exclusion Criteria:
- Actively manic
- Actively suicidal
- Has not been dependent on drugs or alcohol for at least 30 days
- Deemed to be at significant risk of being dangerous to self or others by the patients' WHC physician
- Deemed inappropriate based on judgment of WHC physician informed by WHC staff
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Media Only
|
|
|
Active Comparator: ThinkHuman TV
|
Emotional Education Program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in emotional awareness/intelligence.
Time Frame: 3 month interventional period
|
Assessed using The Emotional Regulation Questionnaire
|
3 month interventional period
|
|
Change from baseline in anxiety.
Time Frame: 3 month interventional period
|
Assessed using The Overall Anxiety Severity and Impairment Scale (OASIS) -Score: Minimum = 0 Maximum = 20 (higher worse outcome) |
3 month interventional period
|
|
Change from baseline in depression symptoms.
Time Frame: 3 month interventional period
|
Assessed using the Center for Epidemiologic Studies Depression scale (CES-D) -Score: Minimum = 0 Maximum = 30 (higher worse outcome) |
3 month interventional period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in quality of life.
Time Frame: After 3 month interventional period
|
Assessed by Q-LES-Q-SF questionnaire -Score: Minimum = 14 Maximum = 70 (higher better outcome) |
After 3 month interventional period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
A limited data set (including all study data with identifiers other than date removed) will be shared by secure file transfer to consultants at Affectifi, Inc and will be available by request from the study investigators upon request through secure file transfer.
Only general summary information will be shared with the study funder.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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