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
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Somatic Symptom Disorder||Behavioral: Emotional Awareness & Expression Therapy Behavioral: Mindfulness Meditation Training||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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|
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
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.
- Generalized Anxiety Scale-7 [ Time Frame: change from baseline to four and eight weeks after baseline ]symptoms of anxiety
- 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.
- Brief Symptom Inventory [ Time Frame: change from baseline to four and eight weeks after baseline ]psychological symptoms
- Patient Global Impression of Change [ Time Frame: four and eight weeks after baseline ]change in health status since the start of the study
- 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.
- 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.
- Emotional Approach Coping Scale [ Time Frame: change from baseline to four and eight weeks after baseline ]emotional approach coping
- 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.
- 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.
- 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.
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
|Contact: Mark A Lumley, PhDemail@example.com|
|Contact: Heather K Doherty, MAfirstname.lastname@example.org|
|United States, Michigan|
|Wayne State University||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Heather K Doherty, MA 313-577-2773 email@example.com|