Kontrollerad Studie av Behandling Med kedjetäcken Mot sömnstörning
Phase: NA
Conditions: Insomnia
Sponsor: Karolinska Institutet

Research plan, translated from Swedish, including a statistical analysis plan 
 
A controlled study of weighted chain blankets 
 
 
Document Date: November 1, 2015 
 
 
 

Scientific description 
Purpose 
The primary aim is to investigate whether the nightly use of a weighted chain blanket has a 
significantly better effect on sleep time, total sleep time and daytime fatigue for patients with sleep 
disturbance in psychiatric disease compared to a light chain blanket(equivalent to placebo) after four 
weeks of use. Secondary issues are whether treatment with weighted chain blanket results in a 
significantly better effect than a light blanket for objectively measured sleep and subjectively 
assessed anxiety, depression, and pain. 
Hypotheses 
The use of the weighted chain blanket allows: 
1. Sleep time decreases. 
2. Sleep stays longer with fewer wake-ups during the night. 
3. The sleep becomes calmer 
4. The sleep becomes less tense 
5. Pain decreases daytime 
6. Pain decreases at night 
7. Anxiety and anxiety decrease daytime 
8. Anxiety and anxiety decrease at night 
9. Fatigue decreases daytime 
10. Concentration capacity increases daytime 
Primary outcome measures 
The patient's subjective symptoms of sleep and day fatigue will be evaluated by the Insomnia Sleep 
Inventory (ISI) and the Fatigue Scale Inventory (FSI) scales. It will also be evaluated by the patient's 
self-assessed values in the self-assessment rating scale developed by Stockholm Utility for evaluating 
ball and chain blankets (hereafter referred to as "rating scale for weighted blankets"). Depression 
and anxiety will be evaluated with the scale Hospital Anxiety and Depression Scale (HAD). Objective 
sleep parameters will be recorded with actigraphs. 
Chief researcher 
Responsible for the study of patients with bipolar disorder and/or ADHD is Bodil Ekholm, leg. 
Occupational Therapist at the Affective Section, Psychiatry Southwest of Stockholm County Council 
(SLSO) and Mats Adler, Medical Doctor and Chief Physician and Section Manager at the Affective 
Section, Psychiatry Southwest in Stockholm County Council (SLSO) 
Overview 
Sleep difficulties are one of the most common reasons for people seeking medical attention. People 
with sleeping problems often report a great deal of suffering and a negative impact on activity. It has 
also been found that it increases the risk of other diseases. It also affects the ability to work, which 
causes high social costs (1-5). Several major studies have shown that between 15 and 50% of the 

adult population report that they have sleep disturbances and that it is an increasing problem (1.5.6). 
Mainly there are sleep difficulties, difficulty in maintaining sleep, as well as nightmares that have 
been reported. Concerning patients in psychiatry, there is a strong link between sleep disorders and 
depression/anxiety (7-13). For patients with bipolar disorder, about 70% report that they have sleep 
disorders (14-15). The traditionally accepted methods of pharmacologically treating these patients 
and CBT do not always yield success (10, 14). Untreated or ineffective treatment often leads to 
chronic sleep disorders (1, 9, 10). 
Occupational therapists work with activity and activity disorders (16). The condition for being active 
is that you have a good sleep. Therefore it is natural that occupational therapists also work with 
sleep disorders. 
Prescription of ball and chain blankets is a common occupational therapy intervention (17-21). 
According to the SBU (22), the purpose of the blankets is to create a sense of security and calmness, 
but that the scientific evidence is insufficient to assess the effect of weight loss in sleep disorders 
caused by motor and/or mental anxiety. However, in cost-benefit assessments, cognitive aids and 
weighted covers for people with mental disabilities have found a clear positive financial outcome for 
both the user, state, municipality, county council and the general economy (23), due to a decrease in 
the need for help and the number of sick leave days. People can stay or introduce themselves to 
work and self-reliance increases. 
In summary, the test/prescription of the ball and chain blankets is a promising, relatively new, 
method for adults with sleep disorders. 
Project plan 
Patients 
Patients with sleep disorders and motor / mental anxiety will be recruited at the Affective section at 
Psychiatry South West. Patients who are expected to use the chain blankets after assessment by the 
attending physician will be included after informed consent. All patients who accepted inclusion and 
who received a chain blanket will be included in the analysis. 
 
Inclusion and exclusion criteria 
We intend to recruit patients from Psychiatry Southwest with affective and anxiety diagnoses and/or 
ADHD, which are simultaneously bothered by sleep disturbance and anxiety/anxiety. Patients are 
recruited from open and inpatient wards. They should have one of the diagnoses Bipolar Disorder 
Type I, Type II Bipolar Disorder, Recurrent Depression, Panic Syndrome, Social Phobia, General 
Anxiety Disorder (GAD) and/or ADHD. They should also have a clinically significant sleep disorder, i.e., 
a rating of 14 or more on ISI. Exclusion criteria are ongoing drug abuse, consumption of sleep 
medication beyond recommended levels (> 7.5 mg zopiclone or 10 mg zolpidem) or cognitive 
problems that make the patient unable to complete the study. 
Characteristics of patient material 
The examined group will be characterized by age, sex, choice of cover, weight, diagnosis, comorbid 
diagnosis and duration of disease. 
 

Procedure 
After the patient has received oral information and signed a written informed consent, 
characterization of the patient material will be made. The study will be conducted in four phases. The 
first week they use their usual blanket (baseline). Sleep, fatigue, anxiety, and depression will be 
recorded with the scales mentioned above. Then a second part follows four weeks when they use the 
blanket randomized to (Week 2-5). In the second phase, patients are randomized to either get a 6 or 
8 kg lining blanket or a lightweight cover of approximately 1.5 kg of the same appearance in which 
light plastic chains are sewn in. This cover is of such low weight that it corresponds to a regular 
blanket and therefore acts as a placebo control. Randomization and instruction, as well as collection 
of blankets after four weeks of use, will be carried out by a person who does not perform the ratings 
at inclusion and follow-up. Patients should maintain their medication unchanged during the study 
period. They are followed up by telephone every week. At the telephone interview information 
about how they used the blanket will be gathered, and patients will estimate their sleep with the 
scales mentioned above. After four weeks of use of the blanket, the final visit for the randomized 
study will be conducted, and data (scales and actigraph) from this visit is the primary outcome of the 
study. 
In the third phase, all patients are offered an open-follow up study in a 4-week (week 6-9) where 
they can choose freely between ball and chain weighted blankets. After these four weeks, everyone 
is called for a second visit with new estimates and collection of actigraph data of (week 9). In the 
fourth phase, patients who wish to continue with one of the weighted blankets will be offered to do 
so. After 12 months, patients who choose to continue using weighted blankets will be contacted by 
telephone to check the extent to which they use the blanket and are asked to estimate the same 
symptoms as before. 
Power Calculation 
In a previously uncontrolled pilot study of weighted-duty non-control groups, the average sleep time 
decreased from 98 minutes (SD 69) to 31 minutes (SD 28). Based on these results, calculating the 
effect of the blanket for a future study where the placebo deck had no effect, and the active blanket 
would have the same effect as in the pilot study figures would want a power of 0.9 with a 
significance level of 0.05, only 15 subjects would be required in the study. However, we have no data 
on the effect of sleep on sleep measured with the ISI scale. Nor is it likely that the placebo blanket 
would not have any effect at all. However, we expect that patient material of about 100 individuals 
should be enough to find a significant effect. 
Statistical analysis 
Comparison between the effect on the groups will be performed after four weeks and eight weeks 
with conventional methods of statistical significance testing in controlled and randomized studies. All 
patients who used the blanket for at least one night will be included in the analysis (equivalent to 
"intention to treat"). Data from patients who discontinue treatment will be asked if they can accept 
to participate in follow-up in the same way as if they had completed treatment. In these cases, data 
are included in the analysis as measured. Secondly, Last Observation Carried Forward (LOCF) or other 
established statistical method is used to handle data from patients who interrupt treatment. 
Self-assessed values before, after eight weeks and 12 months will be analyzed with and at eight 
weeks after with paired t-test for dependent variables. When data distribution does not match 
normal distribution, the analysis will be supplemented by non-parametric tests. 

Timetable 
The study will extend over three years. 
Safety monitoring 
Clinical monitoring will be done by treatment staff on the Affective section in consultation with the 
patient. 
Ethical considerations 
Testing/ordination of the chain blanket in sleep disorders, as well as motor anxiety and/or mental 
anxiety, is a well-known occupational therapy intervention. The method appears effective and has no 
significant adverse effects. However, the method is not sufficiently illuminated and scientifically 
tested. The use of the clinical data recorded as part of routine follow-up will be unidentified and 
therefore does not present a disadvantage to the patient. All procedures will be done with informed 
consent, data will be processed with confidentiality and unidentified. We believe that the 
disadvantages of the patients are small. 
Possible impact 
Sleep disturbances caused by anxiety are one of the common causes of suffering for patients with 
psychiatric diagnoses. If it is confirmed in this study that the chain blankets can reduce this disorder 
for the patient group without having any side effects of treatment, it will represent a very big step 
forward for the treatment of sleep disturbances. 
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