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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
Scientific title
Can floatation-REST (Restricted Environmental Stimulation Technique) relieve symptoms associated with generalized anxiety disorder?
Secondary ID [1] 283346 0
Nil
Universal Trial Number (UTN)
U1111-1147-5648
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 290229 0
generalized anxiety disorder 290230 0
Condition category
Condition code
Alternative and Complementary Medicine 290624 290624 0 0
Other alternative and complementary medicine
Mental Health 290630 290630 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288059 0
Treatment: Other
Comparator / control treatment
The control group receive no treatment.
Control group
Active

Outcomes
Primary outcome [1] 290634 0
Mean score of the Generalized Anxiety Disorder Questionnaire (GAD-Q-IV)
Timepoint [1] 290634 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [1] 304945 0
Mean Montgomery Asberg Depression Rating Scale (MADR-S) score.
Timepoint [1] 304945 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [2] 304946 0
Mean Pittsburgh Sleep Quality Index (PSQI) score.
Timepoint [2] 304946 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [3] 304947 0
Mean Highly Sensitive Personality Scale (HSP) score.
Timepoint [3] 304947 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [4] 304948 0
Mean Mindfulness Attention and Awareness Scale (MAAS) score.
Timepoint [4] 304948 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [5] 304949 0
Mean Experienced Deviation from Normal State Scale (EDN) score.
Timepoint [5] 304949 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [6] 304950 0
Mean Heart Rate Variability (HRV) Score
Timepoint [6] 304950 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [7] 319299 0
Mean Difficulties in Emotion Regulation Scale (DERS) score.
Timepoint [7] 319299 0
Baseline, and at 4 and 7 weeks after intervention commencement.
Secondary outcome [8] 319300 0
Mean Penn State Worry Questionnaire (PSWQ).
Timepoint [8] 319300 0
Baseline, and at 4 and 7 weeks after intervention commencement.

Eligibility
Key inclusion criteria
1. Generalized anxiety disorder as defined by self-diagnosis questionnaires.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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).


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5455 0
Sweden
State/province [1] 5455 0
Varmland

Funding & Sponsors
Funding source category [1] 288070 0
University
Name [1] 288070 0
Karlstad University
Address [1] 288070 0
Karlstad University, department of psychology
651 88, Karlstad
Country [1] 288070 0
Sweden
Primary sponsor type
University
Name
Karlstad University
Address
Karlstad University, department of psychology
651 88, Karlstad
Country
Sweden
Secondary sponsor category [1] 286793 0
None
Name [1] 286793 0
Address [1] 286793 0
Country [1] 286793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289997 0
Centrala etikprovningsnämden Uppsala
Ethics committee address [1] 289997 0
Centrala etikprovningsnämden Uppsala
Drottninggatan 4
753 09 UPPSALA
Ethics committee country [1] 289997 0
Sweden
Date submitted for ethics approval [1] 289997 0
15/09/2013
Approval date [1] 289997 0
09/10/2013
Ethics approval number [1] 289997 0

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 43406 0
Prof Anette Kjellgren
Address 43406 0
Karlstad University, department of psychology
651 88, Karlstad
Country 43406 0
Sweden
Phone 43406 0
+4654-700 21 73
Fax 43406 0
Email 43406 0
anette.kjellgren@kau.se
Contact person for public queries
Name 43407 0
Mr Kristoffer Jonsson
Address 43407 0
Karlstad University, department of psychology
651 88, Karlstad
Country 43407 0
Sweden
Phone 43407 0
+4654-700 18 99
Fax 43407 0
Email 43407 0
kristoffer.jonsson@kau.se
Contact person for scientific queries
Name 43408 0
Mr Kristoffer Jonsson
Address 43408 0
Karlstad University, department of psychology
651 88, Karlstad
Country 43408 0
Sweden
Phone 43408 0
+4654-700 18 99
Fax 43408 0
Email 43408 0
kristoffer.jonsson@kau.se

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary