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Completed

NCT Number: NCT03986125

Student Anxiety & Stress Study

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.

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Key information

Conditions

Anxiety Anxiety Disorders Medically Unexplained Symptoms Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatic Symptom Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Emotional Awareness & Expression Therapy

Behavioral

emotion-focused

Mindfulness meditation training

Behavioral

meditation training and practice

Primary outcomes

  1. Generalized Anxiety Scale-7

    Time frame: change from baseline to four and eight weeks after baseline

    symptoms of anxiety

  2. 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 outcomes

  1. Brief Symptom Inventory

    Time frame: change from baseline to four and eight weeks after baseline

    psychological symptoms

  2. Patient Global Impression of Change

    Time frame: four and eight weeks after baseline

    change in health status since the start of the study

  3. 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.

  4. 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.

Other outcomes

  1. Emotional Approach Coping Scale

    Time frame: change from baseline to four and eight weeks after baseline

    emotional approach coping

  2. Emotional Expressivity Scale

    Time frame: change from baseline to four and eight weeks after baseline

    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.

  3. Cognitive and Affective Mindfulness Scale-Revised

    Time frame: change from baseline to four and eight weeks after baseline

    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.

  4. Acceptance and Action Questionnaire

    Time frame: change from baseline to four and eight weeks after baseline

    ). 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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Acronym: SASS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2019
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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