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Student Anxiety & Stress Study (SASS)

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ClinicalTrials.gov Identifier: NCT03986125
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Mark A. Lumley, 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.

Condition or disease Intervention/treatment Phase
Anxiety Somatic Symptom Disorder Behavioral: Emotional Awareness & Expression Therapy Behavioral: Mindfulness Meditation Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Prior to randomization all parties will be blinded to experimental condition. Post treatment and follow up assessments will be conducted by a blinded research assistant.
Primary Purpose: Treatment
Official Title: Emotional Awareness and Expression Therapy and Mindfulness Meditation Training for College Students With Anxiety and Somatic Symptoms: A Randomized Controlled Trial
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986125


Contacts
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Contact: Mark A Lumley, PhD 3135772247 mlumley@wayne.edu
Contact: Heather K Doherty, MA 3138061829 heatherdoherty11@gmail.com

Locations
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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Heather K Doherty, MA    313-577-2773    heatherdoherty11@gmail.com   
Sponsors and Collaborators
Wayne State University

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Responsible Party: Mark A. Lumley, Distinguished Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03986125     History of Changes
Other Study ID Numbers: 1904002172
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark A. Lumley, Wayne State University:
college students
anxiety
somatic symptoms

Additional relevant MeSH terms:
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Medically Unexplained Symptoms
Anxiety Disorders
Mental Disorders
Signs and Symptoms