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Student Anxiety & Stress Study (SASS)

Primary Purpose

Anxiety, Somatic Symptom Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Awareness & Expression Therapy
Mindfulness Meditation Training
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring college students, anxiety, somatic symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Emotional Awareness & Expression Therapy

Mindfulness Meditation Training

Wait-List Control

Arm Description

Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions.

Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement.

Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization.

Outcomes

Primary Outcome Measures

Generalized Anxiety Scale-7
symptoms of anxiety
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.

Secondary Outcome Measures

Brief Symptom Inventory
psychological symptoms
Patient Global Impression of Change
change in health status since the start of the study
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.
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.

Full Information

First Posted
June 12, 2019
Last Updated
July 14, 2020
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT03986125
Brief Title
Student Anxiety & Stress Study
Acronym
SASS
Official Title
Emotional Awareness and Expression Therapy and Mindfulness Meditation Training for College Students With Anxiety and Somatic Symptoms: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
April 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Somatic Symptom Disorder
Keywords
college students, anxiety, somatic symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotional Awareness & Expression Therapy
Arm Type
Experimental
Arm Description
Participants will attend three individual sessions focused on becoming aware of and expressing avoided or conflicted emotions.
Arm Title
Mindfulness Meditation Training
Arm Type
Experimental
Arm Description
Participants will attend three individual sessions focused on increasing equanimity and compassion and reducing self-judgement.
Arm Title
Wait-List Control
Arm Type
No Intervention
Arm Description
Participants will receive the intervention of their choice following assessment at four and eight weeks after randomization.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Awareness & Expression Therapy
Intervention Description
emotion-focused
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation Training
Intervention Description
meditation training and practice
Primary Outcome Measure Information:
Title
Generalized Anxiety Scale-7
Description
symptoms of anxiety
Time Frame
change from baseline to four and eight weeks after baseline
Title
Patient Health Questionnaire-15
Description
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
Secondary Outcome Measure Information:
Title
Brief Symptom Inventory
Description
psychological symptoms
Time Frame
change from baseline to four and eight weeks after baseline
Title
Patient Global Impression of Change
Description
change in health status since the start of the study
Time Frame
four and eight weeks after baseline
Title
Perceived Stress Scale
Description
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
Title
Satisfaction With Life Scale
Description
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
Other Pre-specified Outcome Measures:
Title
Emotional Approach Coping Scale
Description
emotional approach coping
Time Frame
change from baseline to four and eight weeks after baseline
Title
Emotional Expressivity Scale
Description
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
Title
Cognitive and Affective Mindfulness Scale-Revised
Description
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
Title
Acceptance and Action Questionnaire
Description
). 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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