Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation.
This study has two aims. First, it aims to personalize and optimize breathing protocols. Second, it aims to tailor breathing protocols to subgroups based on prediction models of expected efficacy.
Three different breathing protocols, varying solely in their instructed breathing frequency with 40 percent (A), 60 percent (B), and 80 percent (C) of the interindividual spontaneous breathing frequency, are tested in a randomized, counterbalanced crossover trial. Other parameters, such as breathing quality (i.e., nasal and diaphragmatic), rhythm (i.e., prolonged exhalation without instructed pauses) and depth (i.e., increased depth due to slower breathing frequency) as well as contextual factors (e.g., posture, video-based instructions, type of pacer, etc.) are invariant between protocols.
First, this study hypothesizes a difference in the relaxation response between breathing protocols A, B, and C. This study looks at the relaxation response from three different angles (1) self-report, (2) autonomic arousal, and (3) central nervous system arousal. Second, this study explores prediction models of expected efficacy based on the interindividual variance in characteristics (i.e., depressive, anxious and stress symptoms as well as expertise in relaxation therapies) and biomarkers (e.g., heart rate variability, peripheral temperature, skin conductance, etc.). Prediction models can tailor breathing protocols to subgroups to increase expected efficacy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing Exercise with 40 Percent of the Spontaneous Breathing Frequency (A) | Experimental | Participants are instructed (via visual pacer) to reduce their breathing frequency to 40 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. |
|
| Breathing Exercise with 60 Percent of the Spontaneous Breathing Frequency (B) | Experimental | Participants are instructed (via visual pacer) to reduce their breathing frequency to 60 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. |
|
| Breathing Exercise with 80 Percent of the Spontaneous Breathing Frequency (C) | Experimental | Participants are instructed (via visual pacer) to reduce their breathing frequency to 80 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing Exercise | Behavioral | A breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response). |
| Measure | Description | Time Frame |
|---|---|---|
| Relaxation Sum Score | Measured with the German Version of the Relaxation State Questionnaire; Sum scores range from 10 to 50 (higher scores indicate greater relaxation). | Immediately after each 5-minute breathing exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Current Perceived Stress Level | Measured on a visual analog scale ranging from 0 to 100, where zero is absolutely no stress and 100 is extreme stress. | Immediately after each 5-minute breathing exercise |
| Heart Rate Variability |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing Frequency | Measured via chest strap sensor. This is not an outcome, it measures the participant's spontaneous breathing frequency and the compliance to the breathing protocols. | During the first questionnaire and video-based instructions before the baseline measurement, the 5-minute baseline measurement and during each 5-minute breathing exercise |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lukas Moebus, M.Sc. | Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technical University of Munich | Munich | Bavaria | 80992 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured via blood volume pulse with a finger clip on the middle finger
| During each 5-minute breathing exercise |
| Peripheral Temperature | Measured via temperature sensor on the small finger | During each 5-minute breathing exercise |
| Skin Conductance | Measured via skin conductance sensor on the index and ring finger | During each 5-minute breathing exercise |
| Power in Frequency Bands | Measured via four channel EEG with linked earlobe reference and active electrode placement on F3, F4, F7, and F8 according to the international 10-20 system | During each 5-minute breathing exercise |
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| Difficulty with any of the Breathing Exercises | Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| Transferability of Breathing Exercises into Daily Life | Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| One Word Description for Breathing Exercises | Assessed with an open question. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| Previous Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.) | Assessed with a closed (Yes/No) question. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| Duration of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.) | Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| Average Volume of Training in Relaxation Techniques (such as Breathing Exercises, Autogenic Training, Progressive Relaxation, etc.) | Assessed with a questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| Stress, Anxiety and Depression Score of the Past Two Weeks | Measured with the Depression-Anxiety-Stress-Scale Questionnaire. This is not an outcome measure, this is a measure to build a prediction model for expected efficacy of breathing exercises. | Immidiately after the last breathing exercise |
| D026741 |
| Physical Therapy Modalities |