Generalized Anxiety DisorderNCT03899090
Floatation-REST (Reduced Environmental Stimulation Therapy) for Anxiety and Depression
A study testing Float pool and Float chair in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
This early-stage trial aims to examine the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) or an active comparison condition in 75 participants with clinical anxiety and depression. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
- What is being tested?
- Float pool and Float chair
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- High level of acute anxiety (OASIS score ≥ 6)
- High anxiety sensitivity (ASI-3 total score ≥ 24)
- If taking medication or receiving psychotherapy, must be stably undergoing treatment prior to participation (defined as having taken the medication or been in therapy for 8 weeks or longer). If taking a benzodiazepine or opioid, must be willing to abstain within 24 hours of a float session (daily users will be excluded from the study).
- No prior Floatation-REST experience or a minimum of 1 year since previous float session
- Seeking treatment for their anxiety/depression and willing to complete the study
Who cannot join
- History of Bipolar Disorder, Schizophrenia spectrum or other psychotic disorders
- Current Eating Disorder (anorexia/bulimia nervosa)
- Current Substance Use Disorder ≥ moderate. Tobacco and Caffeine Use is allowed. Must be willing to abstain from all other substances within 24 hours of a float session.
- Active suicidality with plan/intent
- History of a neurological condition (e.g., epilepsy) or any other medical condition that could interfere with the protocol
- Any skin conditions or open wounds that could cause pain when exposed to saltwater
Show all 9Show fewer
- Uncomfortable being in water
- Positive pregnancy test
- Acutely intoxicated day of floating (determined via positive urine drug screen or breathalyzer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: Investigating Floatation-REST as a Novel Technique for Reducing Anxiety and Depression
This early-stage trial aims to examine the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) or an active comparison condition in 75 participants with clinical anxiety and depression.
Read the detailed description
Anxiety and depression are the two most common psychiatric conditions, affecting over a quarter of the population, and representing the leading cause of disability, worldwide. More than three-quarters of patients never receive treatment, and recent meta-analyses and large-scale clinical trials suggest that only about half of patients improve with treatment, with substantially poorer outcomes and adherence in patients with comorbid anxiety and depression. Given the insufficient treatment response and adherence to currently available therapies, it is important to explore novel ways of helping patients with anxiety and depression. Floatation-REST (Reduced Environmental Stimulation Therapy) is a relatively unexplored mind-body intervention for naturally reducing physiological stress by attenuating exteroceptive sensory input to the nervous system through the act of floating supine in a pool of water saturated with Epsom salt (magnesium sulfate). Over the past decade, floating has witnessed a rapid rise in popularity, with hundreds of recreational float centers opening across America. Despite the surge in public interest and consumption, there has been little research investigation Floatation-REST, especially in clinical populations. The investigators recently completed several pilot studies in patients with comorbid anxiety and depression showing that a single float session was capable of inducing a large short-term anxiolytic and antidepressant response accompanied by a substantial improvement in mood and subjective well-being. This proposal aims to follow-up on these promising preliminary findings by investigating the feasibility, tolerability, and safety of undergoing multiple sessions of Floatation-REST or an active comparison condition in 75 participants with clinical anxiety and depression. A subset of these participants will have the opportunity to select their preference with regard to float duration and frequency, providing important information for optimizing the "dose" in future trials. Since this study is aimed at examining feasibility, tolerability, and safety, the primary endpoint is adherence (as a proxy of feasibility), and the secondary outcome measures are dropout rate (as a proxy for tolerability) and adverse effects (as a proxy for safety). An exploratory aim examines the magnitude and duration of the anxiolytic and antidepressant effects of Floatation-REST at both short-term (up to 48 hours) and long-term (up to 6 months) intervals, providing an initial indication for whether any beneficial effects are sustained beyond the float experience. The results of this early phase clinical trials will help optimize the design of a future efficacy study exploring the long-term effects of Floatation-REST.
- Conditions
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Posttraumatic Stress Disorder, Major Depressive Disorder
- Being tested
- Float pool, Float chair
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Panic Disorder, Agoraphobia, Stress Disorders, Post-Traumatic, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Float poolBehavioural
Subject floats supine in a pool of water saturated with Epsom salt in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.
Float chairBehavioural
Subject floats supine in a zero-gravity chair in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Float Pool | Experimental | Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) Receives: Behavioral: Float pool |
| Float Chair | Active comparator | Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) Receives: Behavioral: Float chair |
| Float Pool Preferred | Experimental | Floating supine in a pool for a preferred amount of time (6 total sessions, up to 2 hours/session, as frequently as they prefer within a 12-week period with a minimum of 24 hours between sessions) Receives: Behavioral: Float pool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
As a proxy of feasibility, adherence for each subject = (# of sessions completed)/6.
All subjects (in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.
Measured: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Secondary outcomes (25)
Dropout rate
As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/25.
All subjects (in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.
Measured: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Adverse effects
As a proxy of safety, adverse effects for each subject = # of instances during the study when a subject reports elevations above mild for any negative effects on the side effect checklist (administered after each float session)
Measured: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Psychological Distress on the Brief Symptom Inventory-18
Total Score on the Brief Symptom Inventory-18 [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Anxiety on the Brief Symptom Inventory-18
Anxiety subscale [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Depression on the Brief Symptom Inventory-18
Depression subscale [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Somatization on the Brief Symptom Inventory-18
Somatization subscale [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)
Total score [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)
Total score [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Disability on the Sheehan Disability Scale
Total score [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Anxiety remission
Percent of individuals by condition (chair, pool, pool-preferred) who have a HAM-A score of ≤ 7
Measured: An average of 6 weeks after the final float session
Anxiety responder
Percent of individuals by condition (chair, pool, pool-preferred) who show a 50% reduction on HAM-A or Overall Anxiety Severity and Impairment Scale (OASIS)
Measured: Through study completion, an average of 6 months after the final float session
Depression remission
Percent of individuals by condition (chair, pool, pool-preferred) who have a MADRS score of ≤ 9
Measured: An average of 6 weeks after the final float session
Depression responder
Percent of individuals by condition (chair, pool, pool-preferred) who show a 50% reduction on MADRS or Patient Health Questionnaire-9 (PHQ-9)
Measured: Through study completion, an average of 6 months after the final float session
Depression on the Patient Health Questionnaire-9 (PHQ-9)
Total score [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)
Total score [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)
Total score [Average change pre to post-intervention]
Measured: Through study completion, an average of 6 months after the final float session
Positive Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
Average of Positive Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Measured: Through completion of the final float session
Negative Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
Average of Negative Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Measured: Through completion of the final float session
Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)
Average of Serenity rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Measured: Through completion of the final float session
State Anxiety on the State Trait Anxiety Inventory (STAI)
Average of STAI State Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Measured: Through completion of the final float session
Muscle Tension rating on the Visual Analog Scale (VAS)
Average of VAS muscle tension rating change scores from pre-to-post float all six floats for each condition (chair, pool, pool-preferred)
Measured: Through completion of the final float session
Pain on the Wong-Baker Pain Scale (WBPS)
Average of WBPS rating change from pre-to-post float across all six floats for each condition
Measured: Through completion of the final float session
Trait Anxiety on the State Trait Anxiety Inventory
Average of STAI Trait Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Measured: Through study completion, an average of 6 months after the final float session
Cardiac interoceptive accuracy
Average of Beat-to-squeeze consistency on cardiac interoception task
Measured: Through completion of the final float session
Heartbeat perception rating
Average of heartbeat intensity, task difficulty, and task accuracy ratings
Measured: Through completion of the final float session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start8 Apr 2019
- Primary completion30 May 2023
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of three arms: 1. floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) 2. floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) 3. floating supine in a pool for a preferred amount of time (6 total sessions, up to 2 hours/session, as frequently as they prefer within a 12-week period with a minimum of 24 hours between sessions)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Sahib Khalsa, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899090
- Sponsor's protocol ID
- Float R34
- Other IDs
- R34AT009889
- Status last verified
- Oct 2023
- First submitted
- 4 Mar 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the study results will be deidentified and shared with interested investigators using an online link
Publications
Garland MM, Wilson R, Thompson WK, Stein MB, Paulus MP, Feinstein JS, Khalsa SS. A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals. PLoS One. 2024 Jun 6;19(6):e0286899. doi: 10.1371/journal.pone.0286899. eCollection 2024.
PubMed 38843272Garland MM, Wilson R, Thompson WK, Stein MB, Paulus MP, Feinstein JS, Khalsa SS. A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals. medRxiv [Preprint]. 2023 Jun 8:2023.05.27.23290633. doi: 10.1101/2023.05.27.23290633.
PubMed 37333146
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Floatation-REST as a Novel Technique for Reducing Anxiety and Depression
- ClinicalTrials.gov ID
- NCT03899090
- Acronym / sponsor ID
- Float R34
- Conditions
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Posttraumatic Stress Disorder, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early-stage trial aims to examine the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) or an active comparison condition in 75 participants with clinical anxiety and depression.
Detailed description
Anxiety and depression are the two most common psychiatric conditions, affecting over a quarter of the population, and representing the leading cause of disability, worldwide. More than three-quarters of patients never receive treatment, and recent meta-analyses and large-scale clinical trials suggest that only about half of patients improve with treatment, with substantially poorer outcomes and adherence in patients with comorbid anxiety and depression. Given the insufficient treatment response and adherence to currently available therapies, it is important to explore novel ways of helping patients with anxiety and depression. Floatation-REST (Reduced Environmental Stimulation Therapy) is a relatively unexplored mind-body intervention for naturally reducing physiological stress by attenuating exteroceptive sensory input to the nervous system through the act of floating supine in a pool of water saturated with Epsom salt (magnesium sulfate). Over the past decade, floating has witnessed a rapid rise in popularity, with hundreds of recreational float centers opening across America. Despite the surge in public interest and consumption, there has been little research investigation Floatation-REST, especially in clinical populations. The investigators recently completed several pilot studies in patients with comorbid anxiety and depression showing that a single float session was capable of inducing a large short-term anxiolytic and antidepressant response accompanied by a substantial improvement in mood and subjective well-being. This proposal aims to follow-up on these promising preliminary findings by investigating the feasibility, tolerability, and safety of undergoing multiple sessions of Floatation-REST or an active comparison condition in 75 participants with clinical anxiety and depression. A subset of these participants will have the opportunity to select their preference with regard to float duration and frequency, providing important information for optimizing the "dose" in future trials. Since this study is aimed at examining feasibility, tolerability, and safety, the primary endpoint is adherence (as a proxy of feasibility), and the secondary outcome measures are dropout rate (as a proxy for tolerability) and adverse effects (as a proxy for safety). An exploratory aim examines the magnitude and duration of the anxiolytic and antidepressant effects of Floatation-REST at both short-term (up to 48 hours) and long-term (up to 6 months) intervals, providing an initial indication for whether any beneficial effects are sustained beyond the float experience. The results of this early phase clinical trials will help optimize the design of a future efficacy study exploring the long-term effects of Floatation-REST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants are randomized to one of three arms: 1. floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) 2. floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) 3. floating supine in a pool for a preferred amount of time (6 total sessions, up to 2 hours/session, as frequently as they prefer within a 12-week period with a minimum of 24 hours between sessions)
| Arm | Type | Receives |
|---|---|---|
| Float Pool | Experimental | Behavioral: Float poolFloating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) |
| Float Chair | Active comparator | Behavioral: Float chairFloating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week) |
| Float Pool Preferred | Experimental | Behavioral: Float poolFloating supine in a pool for a preferred amount of time (6 total sessions, up to 2 hours/session, as frequently as they prefer within a 12-week period with a minimum of 24 hours between sessions) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- High level of acute anxiety (OASIS score ≥ 6)
- High anxiety sensitivity (ASI-3 total score ≥ 24)
- If taking medication or receiving psychotherapy, must be stably undergoing treatment prior to participation (defined as having taken the medication or been in therapy for 8 weeks or longer). If taking a benzodiazepine or opioid, must be willing to abstain within 24 hours of a float session (daily users will be excluded from the study).
- No prior Floatation-REST experience or a minimum of 1 year since previous float session
- Seeking treatment for their anxiety/depression and willing to complete the study
Key exclusion criteria (9 listed)
- History of Bipolar Disorder, Schizophrenia spectrum or other psychotic disorders
- Current Eating Disorder (anorexia/bulimia nervosa)
- Current Substance Use Disorder ≥ moderate. Tobacco and Caffeine Use is allowed. Must be willing to abstain from all other substances within 24 hours of a float session.
- Active suicidality with plan/intent
- History of a neurological condition (e.g., epilepsy) or any other medical condition that could interfere with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Float poolSubject floats supine in a pool of water saturated with Epsom salt in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord. | Behavioural | Float Pool, Float Pool Preferred |
| Float chairSubject floats supine in a zero-gravity chair in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord. | Behavioural | Float Chair |
Primary outcome
Adherence
Time frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
As a proxy of feasibility, adherence for each subject = (# of sessions completed)/6. All subjects (in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.
25 secondary outcomes
Dropout rate
Time frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Adverse effects
Time frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Psychological Distress on the Brief Symptom Inventory-18
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety on the Brief Symptom Inventory-18
Time frame: Through study completion, an average of 6 months after the final float session
Depression on the Brief Symptom Inventory-18
Time frame: Through study completion, an average of 6 months after the final float session
Somatization on the Brief Symptom Inventory-18
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Through study completion, an average of 6 months after the final float session
Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)
Time frame: Through study completion, an average of 6 months after the final float session
Disability on the Sheehan Disability Scale
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety remission
Time frame: An average of 6 weeks after the final float session
Anxiety responder
Time frame: Through study completion, an average of 6 months after the final float session
Depression remission
Time frame: An average of 6 weeks after the final float session
Depression responder
Time frame: Through study completion, an average of 6 months after the final float session
Depression on the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)
Time frame: Through study completion, an average of 6 months after the final float session
Positive Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
Time frame: Through completion of the final float session
Negative Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
Time frame: Through completion of the final float session
Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)
Time frame: Through completion of the final float session
State Anxiety on the State Trait Anxiety Inventory (STAI)
Time frame: Through completion of the final float session
Muscle Tension rating on the Visual Analog Scale (VAS)
Time frame: Through completion of the final float session
Pain on the Wong-Baker Pain Scale (WBPS)
Time frame: Through completion of the final float session
Trait Anxiety on the State Trait Anxiety Inventory
Time frame: Through study completion, an average of 6 months after the final float session
Cardiac interoceptive accuracy
Time frame: Through completion of the final float session
Heartbeat perception rating
Time frame: Through completion of the final float session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 38843272Garland MM, Wilson R, Thompson WK, Stein MB, Paulus MP, Feinstein JS, Khalsa SS. A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals. PLoS One. 2024 Jun 6;19(6):e0286899. doi: 10.1371/journal.pone.0286899. eCollection 2024.
- Derived from this study: PubMed 37333146Garland MM, Wilson R, Thompson WK, Stein MB, Paulus MP, Feinstein JS, Khalsa SS. A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals. medRxiv [Preprint]. 2023 Jun 8:2023.05.27.23290633. doi: 10.1101/2023.05.27.23290633.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the study results will be deidentified and shared with interested investigators using an online link
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahib Khalsa, MD, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Float pool and Float chair in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899090, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.