Student Anxiety & Stress Study

NCT03986125 | Completed

• 1 other identifier: 1904002172
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a randomized clinical trial of an emotional awareness and expression intervention (EAET) and a mindfulness meditation intervention (MMT) for Wayne State University students with anxiety and somatic symptoms. Each of these treatments will be compared to a wait list control condition and to one another to evaluate how well the treatments improve physical and psychological symptoms, stress, and interpersonal functioning of 120 Wayne State University students at 4-week and 8-weeks post-randomization. This research is intended to provide an evidence-based approach to working with emotions to improve both anxiety and somatic symptoms in young adults and will illuminate how EAET compares to the commonly used mindfulness training. It is hypothesized that both active interventions will be superior to no treatment, and differences between the two treatments will be explored.

Conditions

Anxiety; Somatic Symptom Disorder

Keywords

college students; anxiety; somatic symptoms

Outcome Measures

Primary Outcomes (2)

• Generalized Anxiety Scale-7

  symptoms of anxiety

  change from baseline to four and eight weeks after baseline

• Patient Health Questionnaire-15

  The 15-item measure asks patients how much they have been bothered by various somatic symptoms such as headaches, back pain, and digestive distress during the previous 2 weeks, with answers ranging from 0 (not at all) to 2 (a lot). Items are summed to generate a total score with higher scores indicating greater distress regarding somatic symptoms.

  change from baseline to four and eight weeks after baseline

Secondary Outcomes (4)

• Brief Symptom Inventory

  change from baseline to four and eight weeks after baseline

• Patient Global Impression of Change

  four and eight weeks after baseline

• Perceived Stress Scale

  change from baseline to four and eight weeks after baseline

• Satisfaction With Life Scale

  change from baseline to four and eight weeks after baseline

Other Outcomes (4)

• Emotional Approach Coping Scale

  change from baseline to four and eight weeks after baseline

• Emotional Expressivity Scale

  change from baseline to four and eight weeks after baseline

• Cognitive and Affective Mindfulness Scale-Revised

  change from baseline to four and eight weeks after baseline

Study Arms (3)

Emotional Awareness & Expression Therapy

EXPERIMENTAL

Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions.

Behavioral: Emotional Awareness & Expression Therapy

Mindfulness Meditation Training

EXPERIMENTAL

Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement.

Behavioral: Mindfulness Meditation Training

Wait-List Control

NO INTERVENTION

Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization.

Interventions

Emotional Awareness & Expression Therapy BEHAVIORAL

emotion-focused

Emotional Awareness & Expression Therapy

Mindfulness Meditation Training BEHAVIORAL

meditation training and practice

Mindfulness Meditation Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Prior to randomization all parties will be blinded to experimental condition. Post treatment and follow up assessments will be conducted by a blinded research assistant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 14, 2019
• Study Start: July 5, 2019
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)