N/A
N=56
The Effects of Emotional Exposure on State Anxiety
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03458702 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: STAI-Y1 Score Assessed at Baseline, Post-Condition and Post-Exposure — 33.48; 33.53; 27.43; 29.78 score on a scale — p=>.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- YogaFit (Behavioral); Quiet Rest (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Texas Tech University
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY STAI-Y1 Score Assessed at Baseline, Post-Condition and Post-Exposure |
33.48; 33.53; 27.43; 29.78; 33.18; 34.48 | >.05 |
| PRIMARY Heart Rate Assessed at Baseline, During Condition, Post-Condition and Post-Exposure |
72.48; 73.59; 101.01; 69.35; 74.51; 70.43 | >.05 |
| PRIMARY Root Mean Square of Successive Differences (RMSSD) Assessed at Baseline, Post-Condition and Post-Exposure |
61.32; 61.87; 62.41; 75.66; 72.75; 79.41 | > .05 |
| PRIMARY Low-frequency Band (LFNU) Assessed at Baseline, Post-Condition and Post-Exposure |
53.50; 53.75; 52.56; 54.50; 58.42; 56.52 | >.05 |
| PRIMARY High-frequency Band (HFNU) Assessed at Baseline, Post-Condition and Post-Exposure |
46.49; 46.25; 47.19; 44.55; 41.58; 43.55 | >.05 |
| SECONDARY RPE Assessed Post-Condition |
10.83; 6.05 | <.05 sig |
Summary
A randomized repeated-measures crossover clinical trial was performed. Forty healthy, female college students completed a 30 min session of YogaFit and a time-matched seated rest condition on separate days. After each condition, participants viewed 30 min of emotional picture stimuli. State anxiety, heart rate and time-domain and frequency-domain measures of HRV were assessed baseline, post- condition, and post-exposure to emotional stimuli. Data were analysed using a condition x time (2 × 3) repeated-measures ANOVA.
Eligibility Criteria
Inclusion Criteria
The inclusion criteria included women who:
- were between 18 and 25 years of age;
- were not suffering from any medical conditions that would influence the results or compromise safety during training-such as disorders effecting balance, or pregnancy;
- who were not taking antidepressant or anti-anxiety medication;
- were not clinically diagnosed with generalized anxiety disorder in the previous six months;
- were within the normal range (± 1 SD from the M) for female college students for trait anxiety according to Spielberger's Trait Anxiety Inventory [(STAI-Y2); range: 40.40 ± 10.15] (Spielberger 1983);
- were within normal (minimal to mild) levels of depression according to the Beck Depression Inventory [(BDI); range: 0-18] (Oliver and Simmons 1984);
- had a normal menstrual cycle (cycles occurring less than every 26 to 35 days and lasting less than 2 or more than 7 days);
- were not considered high-risk for dual energy x-ray absorptiometry (DEXA) based on a standardized questionnaire approved by the University Radiation Safety Committee; and
- were familiar with yoga or had not participated in at least 3 yoga practice sessions.
Exclusion Criteria
- The exclusion criteria included women who:
- were less than 18 or more than 25 years of age;
- were suffering from any medical conditions that would influence the results or compromise safety during training-such as disorders effecting balance, or pregnancy;
- who were taking antidepressant or anti-anxiety medication;
- were clinically diagnosed with generalized anxiety disorder in the previous six months;
- were not within the normal range (± 1 SD from the M) for female college students for trait anxiety according to Spielberger's Trait Anxiety Inventory [(STAI-Y2); range: 40.40 ± 10.15];
- were not within normal (minimal to mild) levels of depression according to the Beck Depression Inventory [(BDI); range: 0-18];
- had an abnormal menstrual cycle (cycles occurring less than every 26 to 35 days and lasting less than 2 or more than 7 days);
- were considered high-risk for dual energy x-ray absorptiometry (DEXA) based on a standardized questionnaire approved by the University Radiation Safety Committee; and
- were not familiar with yoga or had not participated in at least 3 yoga practice sessions.
Data sourced from ClinicalTrials.gov (NCT03458702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.