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

University of South Dakota

Status: Not yet enrolling

Conditions: Depression; Anxiety

Treatments: Behavioral: Mindfulness Meditation; Behavioral: External Qigong; Other: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT06013930

22-247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 3 patient groups

External Qigong

Experimental group

Description:

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

Treatment:

Behavioral: External Qigong

Mindfulness Meditation

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Meditation

Psychoeducation

Active Comparator group

Description:

In the psychoeducation arm, participants will receive recordings online, once a week for three weeks which will be approximately 30 minutes in length.

Treatment:

Other: Psychoeducation