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

NCT06013930 | Completed

• 1 other identifier: 22-247
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Intention to persist in college

  Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).

• 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

  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 Outcomes (8)

• Adverse Childhood Experiences questionnaire.

  Baseline

• Sensation Manikin

  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

  Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).

Study Arms (3)

External Qigong

EXPERIMENTAL

Participants will meet individually with the Qigong practitioner once a week for three weeks for 30-minute segments.

Behavioral: External Qigong

Mindfulness Meditation

EXPERIMENTAL

Participants will meet individually with the mindfulness practitioner once a week for three weeks for 30-minute segments.

Behavioral: Mindfulness Meditation

Psychoeducation

ACTIVE COMPARATOR

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

Interventions

External Qigong BEHAVIORAL

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

External Qigong

Mindfulness Meditation BEHAVIORAL

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.

Mindfulness Meditation

Psychoeducation OTHER

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Dakota: lead
• Subtle Energy Funders Collective: collaborator

Study Sites (1)

University of South Dakota

Sioux Falls, South Dakota, 57107, United States

Location

Related Publications (7)

• 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.

  PMID: 11597055 BACKGROUND

• 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.

  PMID: 31246748 BACKGROUND

• 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.

  PMID: 30058824 BACKGROUND

• 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.

  PMID: 33091745 BACKGROUND

• 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.

  PMID: 19341164 BACKGROUND

• 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.

  PMID: 9635069 BACKGROUND

• 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.

  PMID: 29312052 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Natalie Lecy, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The PI will randomly assign participants to condition and coordinate treatment group scheduling; the assessor will be blinded to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive either: 1) External Qigong, 2) Mindfulness Meditation, or 3) Psychoeducation.

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: August 28, 2023
• Study Start: July 25, 2023
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)