- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536243
RCT Protocol: Emotion Regulation for Eco Anxiety & Eating Concerns in Mexicans Adults
Emotion Regulation-Based Intervention for Eco-Anxiety and Eating-Related Eco-Concerns in Mexican Adults: Protocol for a Randomized Controlled Trial
The goal of this clinical trial is to evaluate the effect of a group intervention based on emotion regulation as a coping strategy for eco-anxiety and eating-related eco-concerns in Mexican adults. The main questions it aims to answer are:
- Does the intervention group show a significant decrease in eco-anxiety at the end of the intervention and at the four-month follow-up?
- Does the intervention group show a significant reduction in eating-related eco-concerns, as well as improvement in emotion regulation and adaptive coping styles?
Researchers will compare the intervention group with the control group to determine whether an intervention based on emotion regulation improves adaptive coping styles.
Participants will:
- Attend the intervention sessions weekly for 6 weeks.
- Complete the assessment instruments at three time points: prior to the start of the intervention, at the end of the intervention, and 4 months post-intervention.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yolanda Campos-Uscanga, PhD
- Phone Number: 13305 +52 2288418900
- Email: ycampos@uv.mx
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 18 to 59 years residing in Xalapa, Veracruz, who respond to the participation call.
Exclusion Criteria:
- Individuals with a known diagnosis of a psychiatric disorder.
- Individuals are currently receiving psychotherapeutic or psychiatric treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Intervention group
|
The program consists of six 90-minute sessions.
Each session will be led by a psychologist with expertise in CBT and group interventions, accompanied by a support psychologist with experience in group settings who will be present throughout all sessions.
Each session follows this structure: welcome, mindfulness exercise, development of a coping strategy, at-home practice activity, and closing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Eco-Anxiety Scores
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Measured using the Eco-anxiety Questionnaire (EAQ-Esp).
Higher scores indicate greater eco-anxiety.
The outcome is the change in scores, specifically whether eco-anxiety scores will decrease or change compared to baseline measurement
|
From enrollment to the end of treatment at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Eating-Related Eco-Concerns
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Measured using the Eating-Related Eco-Concerns Scale (EREC-Esp).
Higher scores indicate greater eating-related Eco-Concerns.
The outcome is the change in scores will decrease or change compared to baseline measurement
|
From enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- CEI-ISP-UV-R07/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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