Clinical trial NCT03986125: Student Anxiety & Stress Study
Official title: Emotional Awareness and Expression Therapy and Mindfulness Meditation Training for College Students With Anxiety and Somatic Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Somatic Symptom Disorder
Keywords: college students
anxiety
somatic symptoms
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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Primary outcomes:
measure: Generalized Anxiety Scale-7
timeFrame: change from baseline to four and eight weeks after baseline
measure: Patient Health Questionnaire-15
timeFrame: change from baseline to four and eight weeks after baseline
Secondary outcomes:
measure: Brief Symptom Inventory
timeFrame: change from baseline to four and eight weeks after baseline
measure: Patient Global Impression of Change
timeFrame: four and eight weeks after baseline
measure: Perceived Stress Scale
timeFrame: change from baseline to four and eight weeks after baseline
measure: Satisfaction With Life Scale
timeFrame: change from baseline to four and eight weeks after baseline
Other outcomes:
measure: Emotional Approach Coping Scale
timeFrame: change from baseline to four and eight weeks after baseline
measure: Emotional Expressivity Scale
timeFrame: change from baseline to four and eight weeks after baseline
measure: Cognitive and Affective Mindfulness Scale-Revised
timeFrame: change from baseline to four and eight weeks after baseline
measure: Acceptance and Action Questionnaire
timeFrame: change from baseline to four and eight weeks after baseline
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: