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Trial registered on ANZCTR
Registration number
ACTRN12613001105730
Ethics application status
Approved
Date submitted
1/10/2013
Date registered
3/10/2013
Date last updated
2/12/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Promising effects of treatment with flotation-REST (Restricted Environmental Stimulation Technique) as an intervention for generalized anxiety disorder (GAD):
A Randomized Controlled Pilot Trial
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Scientific title
Can floatation-REST (Restricted Environmental Stimulation Technique) relieve symptoms associated with generalized anxiety disorder?
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Secondary ID [1]
283346
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Nil
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Universal Trial Number (UTN)
U1111-1147-5648
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
anxiety
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generalized anxiety disorder
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Condition category
Condition code
Alternative and Complementary Medicine
290624
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0
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Other alternative and complementary medicine
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Mental Health
290630
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Floatation-REST (Restricted environmental Stimulation Technique) utilizes sensory deprivation as a way to induce deep relaxation.
Participants receive treatment twice a week during seven weeks. Each treatment session is 45 min long. One of the weeks is without any treatment and can be chosen by the participants.
Participants use floating tanks which is located at Karlstad University, in the human performance laboratory. 4 floating tanks are provided.
Sensory deprivation is reached by lying in a supine position within the floating tank. The tank is filled with a salt-water solution which hold a temperature of 34,7 Celsius degrees. The tank is dark and soundproof, efficiently blocking out external stimuli.
Before the treatment extensive information is given about the treatment and techniques to make the most of the treatment session. If any question arises the participants can ask personal in the lab for further instructions.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
The control group receive no treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Mean score of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
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Assessment method [1]
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Timepoint [1]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [1]
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Mean Montgomery Asberg Depression Rating Scale (MADR-S) score.
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Assessment method [1]
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Timepoint [1]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [2]
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Mean Pittsburgh Sleep Quality Index (PSQI) score.
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Assessment method [2]
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Timepoint [2]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [3]
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Mean Highly Sensitive Personality Scale (HSP) score.
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Assessment method [3]
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Timepoint [3]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [4]
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Mean Mindfulness Attention and Awareness Scale (MAAS) score.
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Assessment method [4]
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Timepoint [4]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [5]
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Mean Experienced Deviation from Normal State Scale (EDN) score.
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Assessment method [5]
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Timepoint [5]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [6]
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Mean Heart Rate Variability (HRV) Score
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Assessment method [6]
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Timepoint [6]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [7]
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Mean Difficulties in Emotion Regulation Scale (DERS) score.
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Assessment method [7]
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Timepoint [7]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Secondary outcome [8]
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Mean Penn State Worry Questionnaire (PSWQ).
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Assessment method [8]
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Timepoint [8]
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Baseline, and at 4 and 7 weeks after intervention commencement.
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Eligibility
Key inclusion criteria
1. Generalized anxiety disorder as defined by self-diagnosis questionnaires.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Pregnancy.
2. Pacemaker.
3. Epilepsy
4. History of psychosis.
5. Bipolar disorder diagnosis.
6. Post traumatic stress disorder (PTSD) diagnosis.
7. Ongoing addiction and/or abuse diagnosis.
8. Severe somatic disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment were done by not informing participants about their allocation until they filled in the baseline assessments.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was conducted by letting the participants draw a lot from a jar, containing slips of papers numbered from 1 to 50. Uneven numbers indicated allocation to treatment condition, and even number allocation to waiting list control condition.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
On the basis of previous studies on float-REST, and after power-calculation (0,8) and anticipated effect size eta-square = 0,138 supports a study of 50 participants randomized on two groups. (Clark-Carter, D.(1997). Doing quantitative psychological research - from design to report. Tabell A15.5a, sid 620. Hove, UK: Psychology Press).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2014
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Actual
15/10/2013
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Date of last participant enrolment
Anticipated
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Actual
1/04/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment outside Australia
Country [1]
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Sweden
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State/province [1]
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Varmland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Karlstad University
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Address [1]
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Karlstad University, department of psychology
651 88, Karlstad
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Country [1]
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Sweden
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Primary sponsor type
University
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Name
Karlstad University
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Address
Karlstad University, department of psychology
651 88, Karlstad
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Country
Sweden
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Centrala etikprovningsnämden Uppsala
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Ethics committee address [1]
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Centrala etikprovningsnämden Uppsala Drottninggatan 4 753 09 UPPSALA
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Ethics committee country [1]
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Sweden
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Date submitted for ethics approval [1]
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15/09/2013
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Approval date [1]
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09/10/2013
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Ethics approval number [1]
289997
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Summary
Brief summary
The study aims to investigate if floatation-REST (Restricted Environmental Stimulation Technique) efficiency as treatment for an anxiety disorder (generalized anxiety disorder; GAD). Th primary hypothesis is that float-REST will relieve symptoms associated with this anxiety diagnosis.
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Trial website
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Trial related presentations / publications
The manuscript for this study is ready and have been submitted to a relevant journal. We have not yet confirmed that it is accepted for publication.
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Public notes
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Contacts
Principal investigator
Name
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Prof Anette Kjellgren
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Address
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Karlstad University, department of psychology
651 88, Karlstad
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Country
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Sweden
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Phone
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+4654-700 21 73
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Fax
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Email
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anette.kjellgren@kau.se
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Contact person for public queries
Name
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Kristoffer Jonsson
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Address
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Karlstad University, department of psychology
651 88, Karlstad
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Country
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Sweden
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Phone
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+4654-700 18 99
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Fax
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Email
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kristoffer.jonsson@kau.se
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Contact person for scientific queries
Name
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Kristoffer Jonsson
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Address
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Karlstad University, department of psychology
651 88, Karlstad
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Country
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Sweden
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Phone
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+4654-700 18 99
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Fax
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Email
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kristoffer.jonsson@kau.se
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Promising effects of treatment with flotation-REST (restricted environmental stimulation technique) as an intervention for generalized anxiety disorder (GAD): A randomized controlled pilot trial.
2016
https://dx.doi.org/10.1186/s12906-016-1089-x
N.B. These documents automatically identified may not have been verified by the study sponsor.
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