Student Anxiety & Stress Study (SASS)

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Somatic Symptom Disorder
• Intervention / Treatment: Behavioral: Emotional Awareness & Expression Therapy; Behavioral: Mindfulness Meditation Training

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotional Awareness & Expression Therapy; Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions.	Behavioral: Emotional Awareness & Expression Therapy; emotion-focused
Experimental: Mindfulness Meditation Training; Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement.	Behavioral: Mindfulness Meditation Training; meditation training and practice
No Intervention: Wait-List Control; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Approach Coping Scale	emotional approach coping	change from baseline to four and eight weeks after baseline
Emotional Expressivity Scale	Measures the extent to which patients outwardly display emotion. The 17-item measure asks patients the degree to which items such as "I display my emotions to other people" describe them on a scale from 1 (never) to 6 (always). Scores are summed to generate a total score with higher scores indicating greater emotional expressiveness.	change from baseline to four and eight weeks after baseline
Cognitive and Affective Mindfulness Scale-Revised	The 12-item measure asks patients to rate the degree to which statements indicating four components of mindfulness (attention, focus on the present, awareness, and acceptance) apply to them, on a scale ranging from 1 (rarely/not at all) to 4 (almost always). Items are summed to generate a total score with higher scores indicating greater mindfulness.	change from baseline to four and eight weeks after baseline
Acceptance and Action Questionnaire	). The 9-item measure assesses avoidance of private experiences such as emotions, thoughts, and memories as well as the ability to take action under adverse circumstances. It asks patients to indicate how true each statement is of themselves on a scale ranging from 1 (never true) to 7 (always true). Items are summed and higher scores indicate greater levels of psychological inflexibility.	change from baseline to four and eight weeks after baseline

Collaborators and Investigators

• Sponsor: Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): April 28, 2020
• Study Completion (Actual): April 28, 2020

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: anxiety; college students; somatic symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Medically Unexplained Symptoms
• Other Study ID Numbers: 1904002172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No