Student Anxiety & Stress Study
- Conditions
- Somatic Symptom DisorderAnxiety
- Interventions
- Behavioral: Emotional Awareness & Expression TherapyBehavioral: Mindfulness Meditation Training
- Registration Number
- NCT03986125
- Lead Sponsor
- Wayne State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
university student, reporting at least moderate levels of anxiety (GAD-7) and somatic symptoms (PHQ-15) -
psychosis, lack of fluency with spoken and written English language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Emotional Awareness & Expression Therapy Emotional Awareness & Expression Therapy Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions. Mindfulness Meditation Training Mindfulness Meditation Training Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement.
- Primary Outcome Measures
Name Time Method Generalized Anxiety Scale-7 change from baseline to four and eight weeks after baseline symptoms of anxiety
Patient Health Questionnaire-15 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 Outcome Measures
Name Time Method Brief Symptom Inventory change from baseline to four and eight weeks after baseline psychological symptoms
Patient Global Impression of Change four and eight weeks after baseline change in health status since the start of the study
Satisfaction With Life Scale 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.
Perceived Stress Scale 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.
Trial Locations
- Locations (1)
Wayne State University
🇺🇸Detroit, Michigan, United States