Student Anxiety & Stress Study

Study Overview
=================
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.

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.

Official Title
-----------------
Emotional Awareness and Expression Therapy and Mindfulness Meditation Training for College Students With Anxiety and Somatic Symptoms: A Randomized Controlled Trial

Conditions
-----------------
Anxiety, Somatic Symptom Disorder

Intervention / Treatment
-----------------
* Behavioral: Emotional Awareness & Expression Therapy
* Behavioral: Mindfulness Meditation Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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 -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotional Awareness & Expression Therapy<br>Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions. | Behavioral: Emotional Awareness & Expression Therapy<br>* emotion-focused<br>|
| Experimental: Mindfulness Meditation Training<br>Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement. | Behavioral: Mindfulness Meditation Training<br>* meditation training and practice<br>|
| No Intervention: Wait-List Control<br>Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Symptom Inventory | psychological symptoms | change from baseline to four and eight weeks after baseline | 
| Patient Global Impression of Change | change in health status since the start of the study | four and eight weeks after baseline | 
| Perceived Stress Scale | 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. | change from baseline to four and eight weeks after baseline | 
| Satisfaction With Life Scale | 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. | change from baseline to four and eight weeks after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
college students, anxiety, somatic symptoms