The Efficacy and Appropriateness of Ball Blankets on Insomnia in Depression in Outpatient Clinics
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Aarhus
- Enrollment
- 45
- Locations
- 4
- Primary Endpoint
- Changes in total night time sleep (TST) measured by actigraphy (Micro MotionLogger Watch)
Study Overview
Brief Summary
The objective of the study is to examine the efficacy of Protac Ball BlanketsTM (PBB) and specifically if the PBB will extend the total sleep time of patients with insomnia due to depression in two psychiatric outpatient clinics at Aarhus University Hospital and Odense University Hospital.
Furthermore, it will be examined whether the PBB will reduce the sleep onset latency, number of awakenings, wake after sleep onset, need for sedatives and hypnotics, the self reported symptoms of depression and anxiety and improve the quality of sleep.
45 patients with depression and insomnia who receive outpatient treatment will be included in this study.
The study is a randomized crossover trial. The data collection period lasts four weeks. Data will be collected using actigraphy, sleep diaries and questionnaires.
Detailed Description
This PhD project is an industrial PhD. The protocol is approved and fully financed by the Innovation Fund Denmark (case number 7038-00157B), Protac A/S, Skanderborg and Aarhus University, Denmark.
The project will take place at The Mood Disorders Clinic, Aarhus University Hospital, Risskov, Central Denmark Region and in The Clinic of Affective Disorders, Department of Psychiatry, Psychiatry in The Region of Southern Denmark.
Background: Depression affects approximately 5% of the Danish population and is associated with significant morbidity and mortality. Proper treatment of these patients is therefore, an important clinical and public health issue. Unfortunately, some symptoms of depression are difficult to manage which is the case for sleep disturbances such as insomnia. Insomnia occurs in the majority of patients with depression, and is characterized as problems with initiating sleep, several awakenings, early wake ups, poor sleep quality, and daytime dysfunction. The causality of the insomnia-depression relationship is debated. Several studies have raised the question whether insomnia is not just a typical symptom of depression but rather an independent clinical predictor of depression, which implicates the importance for primary prevention and specific focus on the treatment of insomnia. Often, medication is used to treat insomnia but pharmacological treatment has side effects and, importantly, there is a risk of drug tolerance and addiction. Increased attention on investigating the known and un-known benefits of non-pharmacological treatment options for sleep disturbances is therefore highly relevant. Non-pharmacological treatments include cognitive behavioural therapy, which has proven effects on insomnia. Cognitive behavioural therapy for insomnia (CBTI) typically includes sleep restriction, stimulus control, cognitive therapy, sleep hygiene and relaxation training. It has been included as the treatment of choice in a campaign by the Danish National Board of Health. Unfortunately, CBTI is limited to patients without severe cognitive problems that are mentally able to participate in therapy sessions. Therefore, more evidence based non-pharmacological treatment options that hit a greater target group are needed if tailor-made management of insomnia in depression is to be achieved.
Ball blankets are a promising option that can be used in all patients including patients with severe cognitive deficits due to depression. It has been shown to decrease sleep disturbances in children with ADHD using the Protac Ball BlanketTM (Protac A/S, Skanderborg, Denmark). The Protac Ball BlanketTM (PBB) has been used in adult psychiatric inpatient settings since the early 1990s for patients suffering from insomnia, anxiety, agitation, manic episodes and psychosis. From a clinical perspective the blankets is experienced to enhance the patient's awareness of the body and its physical delimitation which relieves restlessness, stress and anxiety and provides a sense of security and calm in head and body, which for some resolves in improved sleep quality. This is in line with the mechanism of the PBB, which is to provide a changing sensory stimulation because of the movement of the plastic balls in the blanket. Further, the weighted plastic balls gives a light pressure distributed across numerous points, helping the brain to register the body. During sleep the balls will move because of slight changes in body position and the skin is thus continuously stimulated in new ways.
Clinical experiences support the use of PBB in depression but there are neither RCTs nor qualitative studies on the effects and appropriateness of using PBB in insomnia among adults with depression. Two dissertations on sleeping problems due to dementia or sense of touch and sense of movement issues in kids indicate effects of using ball blankets. Overlap in symptoms between these conditions and depression, i.e. anxiety and sleep disturbances suggests an effect in depression. Currently, ball blankets are used as an unapproved treatment option among adults with depression. However, lack of solid evidence limits the use of PBB in the adult population or may expose some to a useless treatment. Further, if ball blankets are beneficial for a proportion of patients with depression, the lack of data on adult patient hampers further development and improvement of the PBB for the benefit of patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants: Patients with depression according to ICD-10 (F32-33) or (F32-33 in combination with F40-41.2) (males and females, aged ≥18 years) who receive outpatient treatment in The Mood Disorders Clinic, Aarhus University Hospital, Risskov, Denmark and in The Clinic of Affective Disorders, Department of Psychiatry, Psychiatry in The Region of Southern Denmark.
- •Participants must either experience poor sleep quality, sleep onset latency or wake time after sleep onset of: (a) ≥31 min; (b) occurring ≥3 nights a week; (c) for ≥ 14 days (31) or early wake ups, and have a Global Pittsburgh Sleep Quality Index Score ≥5.
Exclusion Criteria
- •Patients that, according to ICD-10 criteria, have been depressed >2 years
- •Patients suffering from hypersomnia (ICD-10: F51.13)
- •Patients with current alcohol- or drug abuse (ICD-10: F10-19)
- •Patients with diseases directly influencing sleep quality (such as severe chronic pain issues, sleep apnoea o.a.)
- •Patients receiving medications causing sleep loss and disturbed sleep
- •Patients with Circadian Rhythm Sleep-Wake Disorders (ICD-10; G47.20-47.26)
Outcomes
Primary Outcomes
Changes in total night time sleep (TST) measured by actigraphy (Micro MotionLogger Watch)
Time Frame: Four weeks
The investigators will detect the change in total night time sleep in minutes (actual sleep time, excluding sleep latency and wakes after sleep onset) by comparing the means of the difference in TST for each participant between period A and B or B and A
Secondary Outcomes
- Patients self-reported symptoms of depression measured by questionnaire using Major Depression Inventory (MDI)(Data will be collected at baseline, after two weeks and after four weeks.The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.)
- Symptoms of anxiety measured by questionnaire using Beck Anxiety Index (BAI)(Data will be collected at baseline, after two weeks and after four weeks.The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.)
- Changes in sleep onset latency (SOL)(Four weeks)
- Quality of sleep measured by questionnaire using the Pittsburgh Sleep Quality Index(Data will be collected at baseline, after two weeks and after four weeks. The difference between PSQI measured at week 2 and week 0 will be compared with the difference in PSQI measured at week 4 and week 2.)
- Symptoms of depression measured by the self-reported Hamilton Depression Rating Scale (HRSD6)(Data will be collected at baseline, after two weeks and after four weeks. The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.)
- Patient-reported outcomes concerning interpersonal sensitivity, neurasthenia, anxiety, and depression measured by questionnaire using The Self-Reported Symptom State Scale SCL-28(Data will be collected at baseline, after two weeks and after four weeks.The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.)
- Changes in number of awakenings measured by actigraphy (Micro MotionLogger Watch)(Four weeks)
- Sedatives and hypnotics measured by medication registration use in sleep diaries(Four weeks)
- Insomnia Severity Status measured by questionnaire using the Insomnia Severity Index(Data will be collected at baseline, after two weeks and after four weeks. The difference between the score measured at week 2 and week 0 will be compared with the difference in score measured at week 4 and week 2.)
- Changes in wake after sleep onset (WASO) measured by actigraphy(Four weeks)