Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001153303
Ethics application status
Approved
Date submitted
22/07/2017
Date registered
7/08/2017
Date last updated
7/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Flotation-REST (Restricted Environmental Stimulation Therapy) have an effect on insomnia?
Scientific title
A Single-Case Study of Flotation-REST (Restricted Environmental Stimulation Therapy) as an Insomnia Treatment: a Pilot Study of Treatment Effects
Secondary ID [1] 292421 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 304133 0
Condition category
Condition code
Alternative and Complementary Medicine 303469 303469 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Flotation-REST (restricted environmental stimulation technique)
Flotation-REST treatment means floating on the back inside of a dark and quiet isolation tank, filled with salt saturated water. The high salt content in the water gives high buoyance, which makes possible to float on top of the water. By keeping the water at skin-temperature, sensory input to the somato-sensory system is reduced. The treatment is delivered individually and the participants are alone in the room with the tank. Instructions on how to use the flotation tanks will be given by a doctoral student in psychology with substantial experience in flotation research. A project assistant (grad student) will meet with the participants briefly before and after each session in order to unlock the facilities and to receive any completed questionnaires that the participants brings with them to be handed in. The project assistant will also alert the participants that sessions have finished, by knocking on the door to the flotation room.

Intervention adherence is assessed in that the project assistant will know whether or not participants show up for their appointment. As the assistant is responsible for unlocking and locking the room the assistent observes the participants entering the float tank room, as well as leaving the room. In case of cancelled appointments, care will be taken to schedule new appointments as soon as possible.

The float tanks (270 cm x 150 cm x 130 cm) are situated in quiet rooms at Karlstad University (Sweden). The float tanks contains water (0.3 m in depth) held at skin temperature (35 degrees Celsius) that are saturated with Epsom salt (magnesium sulphate). The float tanks are insulated to minimize visual and auditory stimuli, and earplugs are used during the float sessions. Toilet and shower can be accessed in the float rooms and the float rooms can be locked from inside by the participants. The participants will be instructed to keep the light out during the float session, and to shower before and after each session. The treatment consists of 12 sessions (á 45 minutes) of flotation-REST over a seven-week period, with two sessions a week. The fourth week is treatment free, in order to simulate the break needed by menstruating participants.
Intervention code [1] 298682 0
Treatment: Other
Intervention code [2] 298683 0
Rehabilitation
Intervention code [3] 298684 0
Lifestyle
Comparator / control treatment
In single case experimental designs, each participant acts as their own control. The baseline values from a pre-intervention period is compared to daily measures over the treatment period. The participants' data from two weeks of baseline will be compared to data from seven weeks of treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302838 0
Primary outcome 1: changes in sleep onset latency (SOL), as measured by daily sleep diaries.
Timepoint [1] 302838 0
Time point: Every day for 14 days before treatment, every day during seven weeks of treatment and during 14 days at follow-up, two months after treatment.
Primary outcome [2] 302947 0
Primary outcome 2: wake after sleep onset (WASO) as measured by daily sleep diaries.
Timepoint [2] 302947 0
Time point: Every day for 14 days before treatment, every day during seven weeks of treatment and during 14 days at follow-up, two months after treatment.
Primary outcome [3] 302948 0
Primary outcome 3: total sleep time (TST) as measured by sleep diaries.
Timepoint [3] 302948 0
Time point: Every day for 14 days before treatment, every day during seven weeks of treatment and during 14 days at follow-up, two months after treatment.
Secondary outcome [1] 337201 0
Secondary outcome 1: insomnia severity as measured by the Insomnia Severity Index (ISI).
Timepoint [1] 337201 0
Time point: Three times during the two weeks of baseline measures, three times during the seven-week long treatment and three times during the two-week long follow-up period two months later.
Secondary outcome [2] 337202 0
Secondary outcome 2: changes in depressive symptomatology as measured by the Montgomery Asberg Depression Rating Scale (MADRS).
Timepoint [2] 337202 0
Time point: Three times during the two weeks of baseline measures, three times during the seven-week long treatment and three times during the two-week long follow-up period two months later.
Secondary outcome [3] 337203 0
Secondary outcome 3: changes in worry about sleep as measured by the Anxiety and Preoccupation about Sleep Questionnaire (APSQ).
Timepoint [3] 337203 0
Time point: Three times during the two weeks of baseline measures, three times during the seven-week long treatment and three times during the two-week long follow-up period two months later.
Secondary outcome [4] 337204 0
Secondary outcome 4: changes in pre-sleep arousal as measured by the Pre-Sleep Arousal Sale (PSAS).
Timepoint [4] 337204 0
Time point: Three times during the two weeks of baseline measures, three times during the seven-week long treatment and three times during the two-week long follow-up period two months later.
Secondary outcome [5] 337205 0
Secondary outcome 5: changes in dysfunctional beliefs about sleep as measured by the Dysfunctional Beliefs and Attitudes about Sleep questionnaire (DBAS).
Timepoint [5] 337205 0
Time point: Three times during the two weeks of baseline measures, three times during the seven-week long treatment and three times during the two-week long follow-up period two months later.
Secondary outcome [6] 337206 0
Secondary outcome 6: changes in sleep-related attentional bias as measured by the Sleep Associated Monitoring Index (SAMI).
Timepoint [6] 337206 0
Time point: Three times during the two weeks of baseline measures, three times during the seven-week long treatment and three times during the two-week long follow-up period two months later.
Secondary outcome [7] 337207 0
Secondary outcome 7: changes in sleep-related safety behavious as measured by the Sleep Related Behavior Questionnaire (SRBQ).
Timepoint [7] 337207 0
Time point: Three times during the two weeks of baseline measures, three times during the seven-week long treatment and three times during the two-week long follow-up period two months later.
Secondary outcome [8] 337208 0
Secondary outcome 8: experiences from flotation-REST for people with insomnia as measured by qualitative interviews (up to 45 minutes long).
Timepoint [8] 337208 0
Time point: Once, one week after treatment has been completed.
Secondary outcome [9] 337533 0
Secondary outcome 9: sleep efficiency (SE) as measured by daily sleep diaries.
Timepoint [9] 337533 0
Time point: Every day for 14 days before treatment, every day during seven weeks of treatment and during 14 days at follow-up, two months after treatment.

Eligibility
Key inclusion criteria
The inclusion criteria were 1) insomnia diagnosis (as diagnosed through the structured clinical interview DSISD), 2) SOL or WASO exceeding 30 min three nights per week (sleep diaries), 3) age between 18-65, 4) not currently receiving other psychological treatments for insomnia, 5) on a stable dose of medication over the last three months (if receiving pharmacological treatment).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were 1) sleep-disturbing medical conditions, medications or untreated sleep disorders that may explain insomnia symptoms (DSISD), 2) other health conditions that would make flotation-rest unsuitable (e.g. pacemaker, open wounds), 3) sleep-disturbing mental problems (SCID-I) that may be worsened during the study period (e.g. recent manic episode), 4) suicide ideation or suicidal behaviours (SCID-I).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
When designing the study, care was taken to closely follow general quality criteria of single case experimental designs (SCED), meaning for example (but not limited to) sufficiently defined outcome criteria, long enough baseline period, randomisation of treatment start times, a minimum of five observations in each study phase for main outcome variables (baseline, treatment, and follow-up), and intersubject replication (multiple participants). Due to assumed irreversible effects of the therapy, intrasubject replication (varying baseline with treatment phases several times) was not conducted.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In SCED, conclusions are strengthened by the replication of findings over several participants. Guidelines sometimes mention at least three or five participants. Ten participants would allow for some potential attrition, thus this number was chosen.
The most established way of reporting results from single case studies is through graphs (so-called visual inspection). The basic idea is that if any significant change has occurred, it will be clearly visible. The result of daily sleep measurements will therefore primarily be reported visually, and in accordance with established recommendations for how single case graphs should be presented to present results in a clear and correct manner. However, one should decide on what kind of visual differences that are meaningful for the current research question. Therefore, in the case of daily measurements of sleep, it is relevant to mark the number of nights where involuntarily time awake before falling asleep or in the middle of the night exceeds 30 minutes (frequently used research and diagnostic criteria at insomnia). If the occurrence of these nights decreases after treatment, then a clinically meaningful change has occurred. As statistical calculations are becoming increasingly common in SCED and required by newer guidelines, we plan to follow the methodological development and complement graphs report with appropriate statistical calculations. We refrain from deciding on a specific statistical method at this point, as we are currently investigating which would be the most appropriate method, but it is likely that the choice falls on a version of "time-series analysis" or "percentage of non-overlapping data" which can handle the specific mathematical circumstances that apply to SCED data, such as autocorrelation and variability within one phase. Results from questionnaires will be presented in tables. In cases where clinically significant differences have occurred, this will be highlighted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/03/2016
Date of last participant enrolment
Anticipated
Actual
25/08/2016
Date of last data collection
Anticipated
Actual
1/04/2017
Sample size
Target
10
Accrual to date
Final
7
Recruitment outside Australia
Country [1] 9079 0
Sweden
State/province [1] 9079 0

Funding & Sponsors
Funding source category [1] 296975 0
University
Name [1] 296975 0
Karlstad University
Country [1] 296975 0
Sweden
Primary sponsor type
Individual
Name
Anette Kjellgren
Address
Karlstad University
SE-651 88 Karlstad
Sweden
Country
Sweden
Secondary sponsor category [1] 295979 0
Individual
Name [1] 295979 0
Kristoffer Jonsson
Address [1] 295979 0
Karlstad University
SE-651 88 Karlstad
Sweden
Country [1] 295979 0
Sweden
Secondary sponsor category [2] 296075 0
Individual
Name [2] 296075 0
Annika Norell-Clarke
Address [2] 296075 0
Karlstad University
SE-651 88 Karlstad
Sweden
Country [2] 296075 0
Sweden
Other collaborator category [1] 279655 0
Individual
Name [1] 279655 0
Rolf Ahlzén
Address [1] 279655 0
Karlstad University
SE-651 88 Karlstad
Sweden
Country [1] 279655 0
Sweden
Other collaborator category [2] 279656 0
Individual
Name [2] 279656 0
Lotta Blomquist
Address [2] 279656 0
Karlstad University
SE-651 88 Karlstad
Sweden
Country [2] 279656 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298178 0
Regional Ethical Review Board in Uppsala (Sweden)
Ethics committee address [1] 298178 0
Ethics committee country [1] 298178 0
Sweden
Date submitted for ethics approval [1] 298178 0
Approval date [1] 298178 0
07/10/2015
Ethics approval number [1] 298178 0
Dnr: 2015/303

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76230 0
Prof Anette Kjellgren
Address 76230 0
Karlstad University
SE-651 88 Karlstad
Sweden
Country 76230 0
Sweden
Phone 76230 0
+4654700 21 73
Fax 76230 0
Email 76230 0
[email protected]
Contact person for public queries
Name 76231 0
Kristoffer Jonsson
Address 76231 0
Karlstad University
SE-651 88 Karlstad
Sweden
Country 76231 0
Sweden
Phone 76231 0
+4654700 18 99
Fax 76231 0
Email 76231 0
[email protected]
Contact person for scientific queries
Name 76232 0
Kristoffer Jonsson
Address 76232 0
Karlstad University
SE-651 88 Karlstad
Sweden
Country 76232 0
Sweden
Phone 76232 0
+4654700 18 99
Fax 76232 0
Email 76232 0
[email protected]

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

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