AnxietySASSNCT03986125
Student Anxiety & Stress Study
A study testing Emotional Awareness & Expression Therapy and Mindfulness Meditation Training in people with Anxiety and Somatic Symptom Disorder, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Somatic Symptom Disorder
- What is being tested?
- Emotional Awareness & Expression Therapy and Mindfulness Meditation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Somatic Symptom Disorder
- Being tested
- Emotional Awareness & Expression Therapy, Mindfulness Meditation Training
- Keywords
- college students, anxiety, somatic symptoms
- Medical subject headings
- Anxiety Disorders, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness & Expression TherapyBehavioural
emotion-focused
Mindfulness Meditation TrainingBehavioural
meditation training and practice
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness & Expression Therapy | Experimental | Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions. Receives: Behavioral: Emotional Awareness & Expression Therapy |
| Mindfulness Meditation Training | Experimental | Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement. Receives: Behavioral: Mindfulness Meditation Training |
| Wait-List Control | No intervention | Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Scale-7
symptoms of anxiety
Measured: 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.
Measured: change from baseline to four and eight weeks after baseline
Secondary outcomes (4)
Brief Symptom Inventory
psychological symptoms
Measured: 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
Measured: 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.
Measured: 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.
Measured: change from baseline to four and eight weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start5 Jul 2019
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986125
- Sponsor's protocol ID
- 1904002172
- Acronym
- SASS
- Status last verified
- Jul 2020
- First submitted
- 12 Jun 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Awareness and Expression Therapy and Mindfulness Meditation Training for College Students With Anxiety and Somatic Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03986125
- Acronym / sponsor ID
- SASS / 1904002172
- Conditions
- Anxiety, Somatic Symptom Disorder
- Keywords
- college students, anxiety, somatic symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness & Expression Therapy | Experimental | Behavioral: Emotional Awareness & Expression TherapyParticipants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions. |
| Mindfulness Meditation Training | Experimental | Behavioral: Mindfulness Meditation TrainingParticipants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement. |
| Wait-List Control | No intervention | –Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Awareness & Expression Therapyemotion-focused | Behavioural | Emotional Awareness & Expression Therapy |
| Mindfulness Meditation Trainingmeditation training and practice | Behavioural | Mindfulness Meditation Training |
Primary outcome
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.
4 secondary outcomes
Brief Symptom Inventory
Time frame: change from baseline to four and eight weeks after baseline
Patient Global Impression of Change
Time frame: four and eight weeks after baseline
Perceived Stress Scale
Time frame: change from baseline to four and eight weeks after baseline
Satisfaction With Life Scale
Time frame: change from baseline to four and eight weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness & Expression Therapy and Mindfulness Meditation Training in people with Anxiety and Somatic Symptom Disorder, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Scale-7 (time frame: change from baseline to four and eight weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020; AzTrials last refreshed its copy on 30 Oct 2026.