Clinical trial NCT06013930: Exploring the Efficacy of Treatments for Anxiety and Depression Among College Students
Official title: Exploring the Efficacy of Alternative Treatments for Depression and Anxiety Among College Students: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: University of South Dakota
Sponsor class: OTHER
Collaborators: name: Subtle Energy Funders Collective
First posted: 2023-08-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either: 1) External Qigong, 2) Mindfulness Meditation, or 3) Psychoeducation.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety
timeFrame: Change from baseline assessment, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
measure: Depression
timeFrame: 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:
measure: Intention to persist in college
timeFrame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
measure: Anxiety
timeFrame: 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).
measure: Depression
timeFrame: 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:
measure: Adverse Childhood Experiences questionnaire.
timeFrame: Baseline
measure: Sensation Manikin
timeFrame: 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).
measure: Trait Self-Transcendence
timeFrame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
measure: Self-Transcendent State
timeFrame: 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).
measure: Perceived Discrimination
timeFrame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
measure: Connectedness to Nature Questionnaire
timeFrame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
measure: Dispositional Mindfulness Scale
timeFrame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
measure: Sense of Belonging in College
timeFrame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
Locations:
city: Sioux Falls
country: United States
facility: University of South Dakota
state: South Dakota
Study officials:
affiliation: Assistant Professor
name: Natalie Lecy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.