Exploring the Efficacy of Treatments for Anxiety and Depression Among College Students

Exploring the Efficacy of Alternative Treatments for Depression and Anxiety Among College Students: A Randomized Control Trial

The goal of this randomized control group is to learn about effective treatments for college students experiencing anxiety and/or depression. The main questions this clinical trial aims to answer are: 1) Can alternative treatments decrease anxiety and/or depression among college students? 2) Can alternative treatments increase retention rates among college students experiencing anxiety and/or depression?

Participants will be randomly assigned to one of three intervention groups: external qigong, mindfulness meditation, or psychoeducation. Researchers will compare outcomes from each group to explore treatment differences.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: External Qigong; Behavioral: Mindfulness Meditation; Other: Psychoeducation

Detailed Description

Method/Design. This study will be a single-site, three-arm, randomized, controlled trial. College students (N=51) with elevated depression and/or anxiety will be randomized to either external qigong (EQ), mindfulness meditation (MM), or psychoeducation (PE). Each intervention will be applied for 30 minutes, once a week for three weeks in a community setting. The co-primary outcomes, depression and anxiety, and the secondary outcome, intention to persist in college, will be assessed by a blinded researcher at baseline, one-week post treatment, and one-month follow-up. Change in sense of connection during the treatment session, measured with a comprehensive battery of self-report indices, will be the primary therapeutic mechanism.

Aims and Objectives. The proposed project's central hypothesis is that EQ will increase students' mental health and intention to persist in college by balancing the flow of energy in their bodies. Aim 1. Examine EQ's acceptability in a sample of college students with depression and/or anxiety. Hypothesis: Student retention (i.e., attendance in both treatment sessions) and self-reported treatment acceptability will be better for EQ relative to PE. EQ and MM will demonstrate equivalent acceptability. Aim 2. Determine EQ's effect on anxiety, depression (co-primary outcomes), and intention to persist in college (secondary outcome) over time. Hypothesis: EQ will decrease depression and anxiety while increasing intention to persist in college relative to PE from baseline to one-month follow-up. The co-primary and secondary outcome scores will not differ between EQ and MM. Aim 3. Investigate EQ's immediate effect on students' sense of connection (therapeutic mechanism). Hypothesis: EQ will increase students' sense of connection relative to PE during the treatment sessions. EQ and MM will have equivalent effects on sense of connection.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57107
      • University of South Dakota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older.
• Currently enrolled in a two or four-year college.
• English speaking.
• Willing to travel to the study location.
• Access to a computer or smartphone with a Wifi connection.
• Score of a three or higher on the Generalized Anxiety Disorder 2-item and/or score of a three or higher on the Patient Health Questionnaire-2.

Exclusion Criteria:

• Not currently enrolled in college.
• Not able to travel to the study location.
• No access to a computer or smartphone with Wifi.
• Score < 3 on the Generalized Anxiety Disorder-2 and < 3 on the Patient Health Questionnaire-2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: External Qigong; Participants will meet individually with the Qigong practitioner once a week for three weeks for 30-minute segments.	Behavioral: External Qigong; External Qigong will be facilitated by a seasoned Qigong practitioner. The Qigong practitioner will assist participants in learning how to use the healing powers of their bodies to decrease feelings of anxiety and/or depression
Experimental: Mindfulness Meditation; Participants will meet individually with the mindfulness practitioner once a week for three weeks for 30-minute segments.	Behavioral: Mindfulness Meditation; Mindfulness meditation will be facilitated by a seasoned mindfulness practitioner. Participants will be guided through a meditation designed to help increase a sense of interconnectedness among their college community. They will also learn how to deconstruct feelings of anxiety and/or depression into sensory, emotional, cognitive, and behavioral components.
Active Comparator: Psychoeducation; In the psychoeducation arm, participants will receive recordings online, once a week for three weeks which will be approximately 30 minutes in length.	Other: Psychoeducation; In the psychoeducation arm, participants will receive information related to managing anxiety and/or depression through a recorded presentation. Participants will learn about stress-management techniques to help reduce symptoms of anxiety and/or depression. They will also receive information on resources that could be helpful in treating anxiety and/or depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Symptoms of anxiety will be assessed through a trait anxiety assessment (State-Trait-Anxiety Inventory). The range of possible scores spans from a minimum score of 20 to a maximum score of 80 - the higher the score, the higher the symptoms of anxiety.	Change from baseline assessment, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
Depression	Symptoms of depression will be assessed through a trait depression assessment (Beck Depression Inventory). Scores from the Beck Depression Inventory range from 0-63, with higher scores representing high depression levels.	Change from baseline assessment, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to persist in college	Change in participants' intention to persist in college will be assessed through an individual item rated in a numeric rating scale. Scores range from 0 to 5 with higher scores reflecting greater intent to remain in college.	Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
Anxiety	Symptoms will be assessed through a state anxiety assessment. Scores range from 0-60 with higher scores indicating higher levels of anxiety.	Changes in participant's state anxiety will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation).
Depression	Symptoms will be assessed through a state depression assessment. Scores range from 0-20 with higher scores indicating higher levels of depression.	Changes in participant's state depression will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Childhood Experiences questionnaire.	Participants adverse childhood experiences will be assessed at baseline to explore how childhood adversities moderate outcomes.The ACEs questionnaire was adapted from the Felitti et al., (1998) wave two survey and current questions used by the CDC's telephone Behavioral Risk Factor Surveillance System survey collected in all 50 states. ACES range between 0-13 and the higher the score, the higher the number of ACES.	Baseline
Sensation Manikin	Change in the distribution of pleasant and unpleasant bodily sensations. Scores can range from 0-100 for pleasant (higher scores indicate higher pleasant feelings) and 0-100 for unpleasant feelings (higher scores indicate higher levels of unpleasant sensations).	Changes in participant's state body sensations will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation).
Trait Self-Transcendence	Change in trait self-transcendence from baseline through 3-month follow-up will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait self-transcendence.	Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
Self-Transcendent State	Change in self-transcendent state will be measured with the Nondual Awareness Dimensional Assessment - State Version. Scores range from 0 to 10, with higher scores reflecting greater self-transcendence.	Changes in participant's self-transcendence will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation).
Perceived Discrimination	Changes in the perception of experiencing discrimination (Everyday Discrimination). Scores range from 0 -54 with higher scores indicating higher levels of discrimination.	Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
Connectedness to Nature Questionnaire	The effects on Connectedness to Nature as a moderator between treatment and outcomes. The scale consists of 16 items rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree) and is scored by creating a mean of the 16 items, with scores ranging from one to five, with higher scores indicating a stronger connectedness to nature than lower scores.	Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
Dispositional Mindfulness Scale	The Metacognitive Processes of Decentering scale (MPoD-t) will be used to assess the effects of dispositional mindfulness as a moderator between treatment and outcomes. Scores range from 0-80 with higher scores indicating higher dispositional mindfulness.	Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
Sense of Belonging in College	The role of treatment type on the participant's sense of belonging in college. Scores range from 0-56 with higher scores indicating higher levels of belonging.	Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).

Collaborators and Investigators

• Sponsor: University of South Dakota
• Collaborators: Subtle Energy Funders Collective
• Investigators: Principal Investigator: Natalie Lecy, PhD, Assistant Professor

Publications and helpful links

General Publications

• Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
• Steer RA, Brown GK, Beck AT, Sanderson WC. Mean Beck Depression Inventory-II scores by severity of major depressive episode. Psychol Rep. 2001 Jun;88(3 Pt 2):1075-6. doi: 10.2466/pr0.2001.88.3c.1075.
• Hanley AW, Garland EL. Mapping the Affective Dimension of Embodiment With the Sensation Manikin: Validation Among Chronic Pain Patients and Modification by Mindfulness-Oriented Recovery Enhancement. Psychosom Med. 2019 Sep;81(7):612-621. doi: 10.1097/PSY.0000000000000725.
• Hanley AW, Nakamura Y, Garland EL. The Nondual Awareness Dimensional Assessment (NADA): New tools to assess nondual traits and states of consciousness occurring within and beyond the context of meditation. Psychol Assess. 2018 Dec;30(12):1625-1639. doi: 10.1037/pas0000615. Epub 2018 Jul 30.
• Knowles KA, Olatunji BO. Specificity of trait anxiety in anxiety and depression: Meta-analysis of the State-Trait Anxiety Inventory. Clin Psychol Rev. 2020 Dec;82:101928. doi: 10.1016/j.cpr.2020.101928. Epub 2020 Oct 10.
• Sims M, Wyatt SB, Gutierrez ML, Taylor HA, Williams DR. Development and psychometric testing of a multidimensional instrument of perceived discrimination among African Americans in the Jackson Heart Study. Ethn Dis. 2009 Winter;19(1):56-64.
• Navarro O, Olivos P, Fleury-Bahi G. "Connectedness to Nature Scale": Validity and Reliability in the French Context. Front Psychol. 2017 Dec 12;8:2180. doi: 10.3389/fpsyg.2017.02180. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• Other Study ID Numbers: 22-247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No