Student Anxiety & Stress Study

Overview

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.

Full Title of Study: “Emotional Awareness and Expression Therapy and Mindfulness Meditation Training for College Students With Anxiety and Somatic Symptoms: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2020

Detailed Description

Anxiety is an increasingly common condition among college students and is often accompanied by somatic symptoms. These conditions impair students' social, psychological, and academic functioning and outcomes. Although students are utilizing campus and community mental health centers at increasing rates, these resources are strained. The present study aims to test the efficacy of two brief treatment options for students.

Integrating techniques from several emotion-focused therapies, the investigators have developed and tested an intervention encouraging the awareness and expression of habitually suppressed or avoided emotions. This Emotional Awareness and Expression Therapy (EAET) has been evaluated with various patient populations including fibromyalgia, irritable bowel syndrome, chronic pelvic pain, and medically unexplained symptoms. Results of these trials suggest that the intervention is efficacious in improving physical and psychological well-being, and is equal to or superior to other psychological interventions for somatic conditions. The present study seeks to advance the EAET literature by evaluating the efficacy of the intervention for a broader population and by employing a strong and conceptually different comparison condition: mindfulness meditation training.

Interventions

  • Behavioral: Emotional Awareness & Expression Therapy
    • emotion-focused
  • Behavioral: Mindfulness Meditation Training
    • meditation training and practice

Arms, Groups and Cohorts

  • Experimental: Emotional Awareness & Expression Therapy
    • Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions.
  • Experimental: Mindfulness Meditation Training
    • Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement.
  • No Intervention: Wait-List Control
    • Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization.

Clinical Trial Outcome Measures

Primary Measures

  • Generalized Anxiety Scale-7
    • Time Frame: change from baseline to four and eight weeks after baseline
    • symptoms of anxiety
  • Patient Health Questionnaire-15
    • Time Frame: change from baseline to four and eight weeks after baseline
    • 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.

Secondary Measures

  • Brief Symptom Inventory
    • Time Frame: change from baseline to four and eight weeks after baseline
    • psychological symptoms
  • Patient Global Impression of Change
    • Time Frame: four and eight weeks after baseline
    • change in health status since the start of the study
  • Perceived Stress Scale
    • Time Frame: change from baseline to four and eight weeks after baseline
    • The 14-item measure asks patients how often they had experienced thoughts and feelings such as lack of control and difficulty coping during the previous 2 weeks, with answers ranging from 0 (never) to 4 (very often). Items are summed to generate a total score with higher scores indicating higher levels of perceived stress.
  • Satisfaction With Life Scale
    • Time Frame: change from baseline to four and eight weeks after baseline
    • The 5-item measure asks patients the degree to which they agree with statements such as “In most ways my life is close to my ideal”, with answers ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to create a total score with higher scores indicating a greater degree of satisfaction with life.

Participating in This Clinical Trial

Inclusion Criteria

university student, reporting at least moderate levels of anxiety (GAD-7) and somatic symptoms (PHQ-15)

Exclusion Criteria

psychosis, lack of fluency with spoken and written English language

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wayne State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mark A. Lumley, Distinguished Professor – Wayne State University
  • Overall Contact(s)
    • Mark A Lumley, PhD, 3135772247, mlumley@wayne.edu

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