An interventional study of Emotional Awareness & Expression Therapy and Mindfulness Meditation Training in Anxiety and Somatic Symptom Disorder, sponsored by Wayne State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-16.
Sponsored by Wayne State University · Not applicable, Interventional, and Treatment
Among 10 studies in Medically Unexplained Symptoms with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Medically Unexplained Symptoms · United States.
Among the 10 studies in Medically Unexplained Symptoms with a site in United States, this one is one of 2 that started in 2019, is one of 9 with no phase, and was the 4th registered.
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's enrollment of 53 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.
Browse Medically Unexplained Symptoms studies →4 of the 10 studies in Medically Unexplained Symptoms with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 20 Medically Unexplained Symptoms studies recruiting now, 6 (30%) set no upper age limit and 12 (60%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2019.
Median enrollment 60 across the 9 interventional studies, 20 across the 1 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
None of the 10 has an industry lead sponsor. The 9 most frequent:
Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Wayne State University has 2 studies filed under Medically Unexplained Symptoms — fewer than ten, so there is no comparison to draw.
2 of the studies in Medically Unexplained Symptoms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07610928Massachusetts General HospitalStress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms | 2027-03-31 |
| NCT07766785McLaughlin Research Institute for Biomedical Sciences, Inc.Grow With Grit: A School Nurse-Led SBIRT Pilot for Early Anxiety Detection | 2027-08 |
Among the 10 studies in Medically Unexplained Symptoms with a site in United States, from their registry updates:
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.
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.
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's enrollment of 53 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.
Browse Medically Unexplained Symptoms studies →Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Compared within Medically Unexplained Symptoms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
-
Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions.
Behavioral: Emotional Awareness & Expression Therapy
Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement.
Behavioral: Mindfulness Meditation Training
Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization.
emotion-focused
meditation training and practice
Generalized Anxiety Scale-7
symptoms of anxiety
Time frame: 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.
Time frame: change from baseline to four and eight weeks after baseline
Brief Symptom Inventory
psychological symptoms
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: change from baseline to four and eight weeks after baseline
Emotional Approach Coping Scale
emotional approach coping
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: change from baseline to four and eight weeks after baseline
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Apr 2020, 9 months.
Of 33 non-industry interventional studies with no phase under Medically Unexplained Symptoms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 9 months is below that.
Counting every sponsor, half of 33 studies reached it within 29 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medically Unexplained Symptoms →