Journal of Sleep Disorders: Treatment and CareISSN: 2325-9639

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Research Article, J Sleep Disor Treat Care Vol: 5 Issue: 1

Feasibility and Effects of Touch Massage and Nurse Led Sleep Counselling in the Treatment of Primary Insomnia

Mats Jong1*, Karin Ljadas2, Erling Englund3, Miek C Jong4 and Jonas Appelberg5
1Associate Professor, Department of Nursing, Mid Sweden University, Sundsvall, Sweden
2Biomedical Analyst, Department of Clinical Physiology, Sundsvall Hospital, Sundsvall, Sweden
3Statistician, Department of Research & Development, Västernorrland County Council, Sundsvall, Sweden
4Associate Professor, Department of Nursing, Mid Sweden University, Sundsvall, Sweden, The Louis Bolk Institute, Driebergen, the Netherlands and National Information and Knowledge centre for Integrative Medicine, Amsterdam, Netherlands
5Senior Lecturer, Biomedical Analyst, Department of Health Sciences, Mid Sweden University, Sundsvall, Sweden and Department of Research& Development, Västernorrland County Council, Sundsvall, Sweden
Corresponding author : Mats Jong
Department of Nursing, Mid Sweden University, Holmgatan 10, SE-85170, Sundsvall, Sweden
Tel: +46 10 1428966
E-mail: [email protected]
Received: October 22, 2015 Accepted: January 18, 2016 Published: January 23, 2016
Citation: Jong M, Ljadas K, Englund E, Jong MC, Appelberg J (2016) Feasibility and Effects of Touch Massage and Nurse Led Sleep Counselling in the Treatment of Primary Insomnia. J Sleep Disor: Treat Care 5:1. doi:10.4172/2325-9639.1000167

Abstract

Background: Cognitive Behavioral Therapy (CBT) is basically the only evidence based treatment both in short- as well as long term treatment of insomnia. Previous studies suggest that massage may have a role in initiating sleep and relaxation. This pilot study investigated the feasibility and effects of tactile massage (TM) and nurse led sleep counselling (SC) in the treatment of primary insomnia. Method: Thirty women with primary insomnia were randomized into three different groups: TM, SC or ‘care as usual’ (CAU) followed by a six weeks intervention period. Sleep quality was assessed with sleep diary and polysomnography.

Results: The results show that it is feasible to treat primary insomnia with TM. ‘Within’ group analysis showed that the TM group experienced significant improvements in measures of subjective sleep, SC and CAU had no improvements. No significant differences were found in the ‘between’ group analysis.

Conclusion: On the basis of the findings, we can conclude that it is feasible to use the methods of TM and SC in the treatment of primary insomnia. Especially TM shows preliminary improvements in subjective measures of sleep, results which needs confirmation in full scale research. Based on the observed effects the research protocol/design is recommended to be simplified and also to combine TM and SC as intervention in future studies.
 

Keywords: Complementary and alternative medicine; Nursing; primary insomnia; Tactile massage

Keywords

Complementary and alternative medicine; Nursing; primary insomnia; Tactile massage

Introduction

Insomnia is a public health issue in the Western world where up to 25% of US citizens report occasional insomnia and 9% persistent insomnia [1]. Similar prevalence’s are reported in France [2], Canada [3] and Norway [4]. Persistent insomnia is more reported among women as compared to men [1,2,5]. Even though insomnia is a prevalent problem, few people seek professional consultation for their problems [3]. Primary insomnia, accounting for approximately 25% of all chronic insomnia cases [6], is a sleep disorder without medical, psychiatric or environmental cause where the predominant complaint is “difficulty initiating or maintaining sleep, or nonrestorative sleep, for at least 1 month”. The sleep disturbance (and associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning [7].
Sleep plays an important role in the balance act between health and disease with its recovering effects on the body through restorative functions of the immune system. Insufficient sleep and restitution after stressful events can lead to a state of exhaustion and burnout [8,9], reduced emotional and physical wellbeing [10], development of metabolic syndrome [11,12], as well a higher risk of cardiovascular disease as explained by stress physiology [13].
The aetiology of primary insomnia is multifactorial, anxiety and depression may be the primary causes of poor sleep [14], but anxiety and depression can just as well be caused by the sleep disturbances [15]. It is suggested that stress may be the common denominator, affecting sleep both physiologically and psychologically. Both the stress itself and problems in managing stress can lead to sleep disturbances [9] as well as depression [16].
Insomnia can be treated in several ways, most commonly used are pharmacological treatments with hypnotics and different forms of behavioural therapies [15-18]. Pharmacological treatments are effective in a short term perspective (up to four weeks) [19], but there is a high risk for side effects as well as that sleep disturbances may return after termination of treatment [15,20].
It is shown that cognitive behavioral therapy (CBT) is more effective than pharmacological treatment both in short- as well as long term treatment of insomnia [21], which is also supported by results from other studies [22,23]. In contrast, it is also reported that there is no definite evidence that one of the methods are to be preferred over the other [16]. Additionally, results from a recent systematic showed that pharmacological treatments hold a higher evidence of treatment effect as compared to CBT [19].
CBT for sleep disturbances does not consist of one specific method, but a broad range of different treatments from educational packages, internet based sleep schools to purely behavioural strategies. Element of CBT includes: Sleep hygiene education, stimulus control and sleep restriction therapy. Sleep hygiene education refers to learning individuals of how lifestyle- (diet, exercise, drugs) and environmental factors (light, noise, temperature) influence sleep. Stimulus control includes advice and instructions aiming to help the individual to once again associate the bed to sleep more than with frustration and anxiety due to lying awake in bed trying to sleep. Sleep restriction therapy is a method which aims to help individuals to sleep a larger proportion of the time spent in bed by stimulating the homeostatic drive for sleep [24].
Massage as a treatment modality is present in most cultures and up to the pharmacological revolution in the middle of the last century it was an essential part of mainstream medicine [25]. The empirical support for the benefits of massage has been documented regarding reduction of anxiety [25,26], better glycaemic control [27], infant growth [28], as well as reduced pain and improved sleep [29-31].
Massage is the most commonly used CAM (Complementary and Alternative Medicine) modality in Sweden [32]. Tactile (touch) massage (TM) was developed in Sweden about 30 years ago. TM is a soft superficial massage which follows the anatomy of the body without penetrating in to the deeper tissues. In contrary to the Swedish classical massage, which at times can be painful, TM should never cause pain. The method aims to stimulate attention, close contact and communication through touch. Another aim is to reduce worry and stress and ease pain and thereby promote wellbeing [33]. In Sweden TM is used in several contexts; in health promotion [34], primary care [29] and elderly care [35]. It is applied to different patient groups, to improve general physical conditions [29] and to increase relaxation and reduce agitation in dementia [35-37].
Rationale and objective:
A systematic review on insomnia and CAM [38] concluded that there is evidentiary support for CAM interventions such as acupressure, tai chi and yoga in the treatment of chronic insomnia. Mixed evidence was found for acupuncture and L-tryptophan, and weak and unsupportive evidence for herbal medicines such as valerian. In addition, it was reported that there were not enough studies on insomnia and mainstream CAM therapies such as massage, homeopathy and aromatherapy to come to any conclusion on efficacy. A second review on CAM and insomnia concluded insufficient evidence for any CAM therapy [19]. Because of contradictory results and lack of studies, it is important to investigate if CAM interventions are to be part of the treatment options for insomnia.
This randomized pilot study investigated the feasibility and initial efficacy of two treatments, tactile massage (TM) and nurse led sleep counselling (SC) for primary insomnia compared with a care as usual (control group) in parameters of sleep quality, stress/burnout and anxiety.

Method and Material

This randomized pilot study followed an experimental prospective design with three parallel groups of equal size (n=10) of which two treatment groups, and a control group, with a total of n = 30. The first treatment group underwent an intervention which consisted of: TM administered twice a week for six weeks. The second treatment group underwent SC administered once a week for six weeks. The groups were subject to analysis of between group effects, as well as within group changes (compared to baseline).
The Ethics Committee at Umeå University approved the study (DNR 07-001).
Outcome measures
Parameters of sleep were assessed with the Karolinska Sleep Diary (KSD) [39-41] and Polysomnography (PSG). The KSD consists of items referring to initiation and maintenance of sleep as well as a global appreciation of sleep. The diary has been validated against polysomnography and shown good correlations with objective sleep measures, [39,40]. The method of PSG refers to the simultaneous recording of several physiological variables to objectively assess patterns of sleep: Electroencephalogram (EEG: C3-A2; C4-A1; O1- A2; O2-A1) with; Electrooculogram (EOG: ROC-A1 and LOC-A2); Electromyogram (EMG); Electrocardiogram (ECG); airflow (oral and nasal); respiratory effort (thoracic and abdominal); body movements; and oxygen saturation (oximeter) [42].
The primary outcome measures to determine differences in sleep parameters between the three groups, and comparing with baseline data were as follows:
Sleep onset latency: the time in bed until falling asleep (KSD and PSG)
Number of awakenings during nighttime sleep – arousals – wake time during sleep (KSD and PSG)
Total sleep time (KSD and PSG).
Sleep efficacy expressed in percent of time asleep while in bed (KSD and PSG)
Sleep quality—phrased “How did you sleep?”—very well (5), very badly (1) (KSD)
Sleep Quality Index: formed by 4 of the items in KSD (sleep quality, calmness of sleep, easy to fall asleep, and slept throughout the allotted time)
Secondary outcome measures referring to subjective stress and burnout were assessed with the Shirom – Melamed Burnout Questionnaire (SMBQ), an instrument with high validity and reliability [43]. Changes with respect to anxiety and depression were assessed with the Hospital and Depression Scale (HADS) [44-46]. HADS was initially developed to study hospital related anxiety and depression, but has also been used in other contexts, showing high validity and reliability [47,48].
Data collection
Assessments on subjective sleep quality and daytime sleepiness (KSD) were carried out daily every morning by the women for seven days during baseline (week 0), every day during the intervention period of 42 days (week 1-6), for seven days (week 7) as a short-term follow after termination of treatment, and for seven days (week 13) as a longterm follow up. PSG was assessed four times. In order to familiarize the women with the monitoring equipment they first made a PSG on a habituation night (which also served as screening for primary insomnia), 3-4 weeks later they underwent baseline PSG , at one night in week seven, and one night in week 13. During the PSGs, participating women slept at the patient hotel of the local hospital. Assessment of SMBQ and HADS were made the same day as the PSGs.
Objective sleep quality
Objective sleep quality was assessed using the method of Polysomnography (PSG), which refers to the simultaneous recording of several physiological variables during sleep: electroencephalogram (EEG) with four channels (C3-A2, C4- A1, O1-A2, O2-A1); electrooculogram (EOG) with two channels (LOC-A2, ROC-A1); electromyogram (EMG) with two channels (submental and tibialis anterior) using surface electrodes; electrocardiogram (ECG) with one channel; airflow with two channels (oral and nasal); respiratory effort with two channels (thoracic and abdominal); body movements; and oxygen saturation (oximeter) [42]. For overnight PSG, EMBLA digital recording equipment was used (EMBLA S7000, Embla Systems Inc., CO, USA). Scoring of sleep was performed manually by an experienced analyst and in accordance to standard criteria [42]. The following parameters were determined: sleep latency (SL), total sleep time (TST), sleep efficiency (SE), REM latency (RL), arousal index (AI), wake after sleep onset (WASO), non-REM sleep stages (1, 2) and slow-wave sleep (SWS), REM (rapid eye movement) stage, apnea and hypopnea index (AHI) and periodic leg movements (PLM).
Interventions
Tactile Massage (TM): The first treatment group received TM which was administered twice a week during the six week intervention period by an experienced female therapist (KL). The treatments were given in a secluded room with stable temperature, and the therapist was instructed to address all women in a similar way, talk and behave normally and politely making sure that the woman was laying comfortably and relaxed. All women in the TM group received a full body massage during one hour. The treatment itself followed the standardized method of Tactipro tactile massage [33]. The hand pressure of the therapist during treatment is approximately 2.5 N and the velocity of moving is 1-5cm/sec. The massage movements follow the skin dermatomes and the Langer’s lines (cleavage lines) of the skin. During the TM sessions no advice or counselling was given concerning the woman’s sleep
Nurse led sleep Counselling (SC): The second treatment group received individual nurse led sleep Counselling once a week (1 hour) for six weeks (MJ). The design of the six week program was developed by MJ and a researcher from Karolinska Institutet and was based on the practical experience at Karolinska Institutet [9] as well as on elements present in literature concerning CBT for sleep problems [24]. A general objective of CBT in sleep therapy is to improve sleep by supporting the subjects to change poor sleep habits and to challenge negative thoughts, attitudes and beliefs about sleep. The six sessions of the program included an array of elements;
-monitoring and discussing their own patterns of sleep – motivation for change
-general knowledge and facts of sleep, circadian rhythms and what happens physiologically when stress and other factors affects daily life and sleep.
-methods for relaxation; the women were informed and encouraged to use different exercises for relaxation (guided visualization and simple meditations on sound files, emotional/creative writing).
-information and advice regarding sleep hygiene connected to lifestyle habits (no food close to bedtime, no intense exercise close to bedtime, avoidance of drugs and alcohol) and the physical environment in the bedroom (cool space, darkness during sleep, no visible clock), as well as the importance of relaxation during the evening prior to going to bed.
-stimulus/control; the bedroom as a place for sleep, or sex (not for reading, work or watching TV), to go to bed when sleepy, to leave bed if they have not fallen asleep within 15-20 minutes (go back when feeling sleepy), fixed time for getting up in the morning all weekdays regardless of how much slept, not to sleep during daytime.
-sleep restriction; On the basis of the sleep diaries the subject actual time slept while in bed was identified. This formed the basis for setting up a routine for night-time sleep. If they slept for example six hours, they were allowed to spend six hours in bed totally.
The different elements were used with all women in the SC group, but dependent on their individual interest, knowledge, motivation for change, type and severity of problems, the treatment was individualized according to their specific needs. Between each session they subject had “homework” which was followed up at the subsequent session.
Statistical methods
We conducted Friedmans ANOVA and Kruskal Wallis ANOVA, with Wilcoxon signed rank test as posthoc test when appropriate in order to explore the differences in sleep parameters between the treatment and control groups [49,50]. For the purpose of data reduction, mean values of sleep parameters were computed before being analyzed. Daily values for each item in the KSD were calculated into mean values covering the seven days of the week (week 0-7 and week 13). Week seven was missing in two persons in the group Sleep Counselling. Also, in week 13, ten days in total were missing for the value of subjective sleep onset latency, and the mean of one or two (when possible) values before and after was used as estimated value. The weekly value has been used in order to test for differences ‘between’ the three groups. Similarly, the mean week values were used in the ‘within’ group analysis, where the baseline value (week 0) was used as the contrast against to compare with values from week one through thirteen. Due to the relatively small sample, non-normality of data and the characteristics of the questionnaire (ordinal data level), all data were analysed with non-parametric methodology.
Statistical analysis was made using IBM SPSS statistics (version 23). A p-value of 5% was used as the level of significance.
Sample size: This was a pilot study testing feasibility and initial efficacy and since there was a lack of reliable data to use as a basis for calculation of sample size no power analysis was made. The sample size was determined from what was reasonable to perform due to the high treatment intensity and the strict inclusion criteria.
Material
Inclusion criteria’s: In order to be eligible for participation subjects were to be of female gender, between 18-65 years of age and suffer from primary insomnia according to the definition of the Diagnostic and Statistical Manual of Mental Disorders version IV [7, pp 599, 604] (The Diagnostic and Statistical Manual of Mental Disorders V was not published when the study was performed).
Exclusion criteria’s: pregnancy, drug or alcohol abuse, use of hypnotics, affective bipolar disorder, pain conditions and severe menopause problems. Additionally, severe snoring, presence of Restless legs syndrome (RSL), periodic limb movement disorder (PLMD) and obstructive sleep apnea syndrome (OSAS) comprised exclusion criteria’s that was assessed via Polysomnography and Epworth Sleepiness Scale, ESS [41].
Women were recruited from the waiting list for sleep diagnostics of the local hospital departments of physiology as well as from larger workplaces in the geographical area. First woman was included in January 2008, and last in February 2010. During the procedure of acquiring informed consent from interested women, they were informed that they first needed to undergo sleep diagnostics (polysomnography, and Epworth Sleepiness Scale, ESS for screening of sleepiness [41]) in order to determine if they might have a medical condition explaining their sleep problems. Sixty women underwent the screening procedure of which 30 did not enter the study because their sleeping problems were caused by a medical condition. In total 30 women were eligible for participation and randomized into one of the three groups. No woman dropped out after being included. A statistician otherwise not involved the study, randomized (drawing lots) in blocks (stratification) of three women (one into each group) into the groups. Stratification was done in order to control for seasonal factors.

Results

Demographics and baseline data
As seen in Table 1, showing baseline characteristics of the women, the three groups were highly comparable.
Table 1: Baseline Characteristics of the three groups. Significance test refers to a Kruskal-Wallis test.
Sleep onset latency (SLAT)
Subjective data (KSD): No significant differences were observed ‘between’ the three groups. ‘Within’ group analysis shows significant results (Friedman’s ANOVA p<0.05) for the two intervention groups with improvements (shorter SLAT) during the treatment period most apparent within the TM group, Table 2a and 2b For the full group: At baseline the women had a median SLAT of 31.0 min (range: 11.5 – 124.3) and at 13 weeks follow up 20.0 min (range: 3 – 63), a significant decrease over time (Friedman’s ANOVA, p<0.05).
Table 2a: Subjective sleep variables tested in the study (The Karolinska Sleep Questionnaire). Comparisons are made within the treatment groups and the control group using Friedmans test. Comparisons of values at baseline and values from week one through 13 defines the contrast and are tested with Wilcoxon test. Every plus sign (+) indicates a statistically significant difference (p< 0.05) (a positive improvement of the variable) between baseline values (week 0) and a weekly value during the study period.
Table 2b: Subjective sleep variables tested in the study (The Karolinska Sleep Questionnaire). Comparisons are made within the treatment groups and the control group using Friedmans test. Comparisons of values at baseline and values from week one through 13 defines the contrast and are tested with Wilcoxon test. Values represents the median and minimum/maximum value.
Objective data (PSG): No significant differences were observed neither ‘between’ nor ‘within’ groups. Baseline mean SLAT obtained in polysomnography was 19.8 (±14.9) and 28.4 (±64.8) at 13 weeks follow up (large variation due to one person in the control group who was awake the whole night) (Table 3).
Table 3: Objective sleep variables as measured with polysomnography. No significant results were observed neither in between group analysis, nor in within group analysis (Kruskal-Wallis ANOVA and Friedman ANOVA) in any of the variables.
Number of awakenings arousals and total wake time during sleep
Subjective data (KSD): In ‘between’ group analysis demonstrated no significant differences between the three groups. ‘Within’ group analysis showed improvements (less number of awakenings) for only the TM group during the treatment period (Friedman’s ANOVA, p<0.05), (Table 2a and 2b). In the analysis of the full dataset, a significant decrease of number of awakenings could be observed for the whole sample (Friedman’s ANOVA, p<0.05).
Objective data - Arousals (PSG): No significant differences were observed neither ‘between’ nor ‘within’ groups. Baseline median obtained for the full data set in polysomnography was 39.5 (range: 12-120) and 40.0 (range 1-86) at 13 weeks follow up (Table 3).
Subjective data – Total Wake time during sleep (KSD): No significant differences were observed neither ‘between’ nor ‘within’ groups. At baseline 63.3% (n=19) were awake <30 minutes/night, and 36.7% (n=11) were awake 30 minutes or more.
Objective data – Total Wake time during sleep (PSG): No significant differences were observed neither ‘between’ nor ‘within’ groups. Baseline median obtained in polysomnography was 69.3 (range: 22.5-175.0) and 58.0 (range: 9.0-382) at 13 weeks follow up (huge variation due to one person in the control group who was awake the whole night) (Table 3).
Total sleep time (TST)
Subjective data (KSD): No significant differences were observed in ‘between’ group analysis. In the ‘within’ group analysis a significant improvement over time was observed only for the TM group (Friedman’s ANOVA, p<0.05) (Table 2a and 2b). For the full group: At baseline the participants had a median TST of 390.0 min (range: 132-485) and at 13 weeks follow up 394.0 min (range: 113-490), p>0.05.
Objective data (PSG): Baseline median obtained in polysomnography was 407.8 min (range: 184.5-526.5) and 431.5 min (range: 23.0-551) at 13 weeks follow up (Table 3).
Subjective sleep quality – Sleep quality index
No statistical significant differences were found regarding subjective sleep quality (KSD - How well did you sleep?) in the ‘between’ groups analysis, or in the ‘within’ group analysis (p>0.05) (Table 2a and 2b).
The Sleep Quality Index showed improvement for the full sample over time (Friedman’s ANOVA, p<0.05). No statistical significant differences were found in the ‘between’ groups analysis. In the ‘within’ group analysis it was noted that only the TM group had a significant improved Sleep Quality Index (Friedman’s ANOVA, p<0.05) (Table 2a and 2b).
Stress/Burnout (SMBQ)
At baseline a total of 11 (37%) women could be classified as having a high degree of burnout (>4.0 in the Shirom Melamed Burnout Questionnaire). See Table 4 for more detailed values in each group. No statistical significant differences were detected in the ‘between’ group analysis, but in the ‘within’ group analysis, the TM group showed a significant decrease in the SMBQ raw value directly after treatment (Week 7) (Friedman’s ANOVA, p<0.05).
Table 4: Measures of stress and burnout (Shirom Melamed Burnout Questionnaire-SMBQ) and the total score for anxiety and depression (Hospital Anxiety and Depression Scale-HADS).
Anxiety and depression (HADS)
No statistically significant differences were observed in either depression or anxiety subscales between the three groups, as measured with the Hospital Anxiety Depression Scale (HADS). Three women (10%) were classified as having a symptoms of depression (Cut off >8) at baseline, and 4 (13%) at three month follow up (week 13). Eight (27%) women were classified as having symptoms of anxiety disorder (Cut off >8) at baseline, and 6 (20%) at three month follow up (week 13).
In ‘within’ group analysis (Baseline versus 3 month follow up) women in the Control group had a significant increase (Friedman’s ANOVA, p<0.05) in HADS total score.
Adverse events
No adverse events related to the interventions were observed.

Discussion

Results indicate that it is feasible and safe to treat primary insomnia with TM and SC. Recruitment of participants took considerable time due to the strict inclusion criteria where they also needed to undergo polysomnography in order to exclude other medical diagnosis than primary insomnia. In order to recruit 30 participants, in total 60 women were screened to meet the inclusion criteria. No statistically significant differences between the three groups were found after treatment and follow-up. ‘Within’ group analysis revealed that women in the TM group showed significantly more improvements in subjective measures of sleep (KSD) after treatment and follow-up compared to the SC group, whereas the control group showed little to none improvement. In addition, a positive change was observed with less stress/burnout (SMBQ) in the TM group and even an increase of anxiety/depression in the control group. Due to the fact that this was a pilot study with a small sample size, results must be interpreted with caution and viewed as preliminary effects. Observed significant effects were only apparent in the ‘within’ group analysis and not between groups, Therefore, the findings of the present study cannot be generalized, but need confirmation in a larger study. Since there is a good evidence base for the positive effects of SC [16,19,22-24], it was unexpected to find in the present study that that women in the SC group demonstrated little improvement. Maybe the lack of improvement is due to a relatively short follow up period. However, in sleep counselling the individual person with sleep problems needs to work hard with the tools and knowledge they acquire during therapy. This means that SC is expected to be a real ‘intervention’, requiring active participation of the subjects. In general practice it is described that physicians find it hard to work with ‘sleep hygiene’ and rarely refer people with primary insomnia to CBT. They mostly prescribe a drug to treat insomnia [51]. The observed effects within the TM group are difficult to interpret since TM is a ‘passive’ intervention, where the women received in total twelve TM treatments. There are studies that suggest that better sleep is a “side effect” of different types of massage [29-31]. Our interpretation is that by receiving TM, the women have been able to maintain a higher degree of relaxation which is sustained during the treatment period. They thereby have a “window of opportunity”, possibly due to a general decrease of hyper-arousals [52,53], to deal on their own with background issues related to poor sleep. Similarly, in a qualitative study on nursing staff it is expressed that TM may contribute to reduced levels of stress and pain and increase work ability [34]. Our assumption is also supported from a physiological perspective as it has been shown that touch massage the activity in both the sympathetic and parasympathetic nervous system in healthy volunteers, leading to decreased overall autonomic activity and maintenance of autonomic balance [54]. Several studies support the idea that primary insomnia occurs as a part of a general cognitive, emotional and physiological hyper-arousal which feeds its development and maintenance [52,53]. It could be argued that the effect present in the TM group could be attributed to contextual factors, since they were “exposed” to a care provider a longer time than the SC group, as well as the controls. However, both interventions followed a treatment protocol deemed feasible in clinical practice. Existing SC interventions have in practice similar or even less intensity [55,56] and hence if we would create a protocol that was more intense it would not be feasible to implement.
Studying the baseline data of the full sample, it presents us with the picture of a group of women with somewhat less (subjective) total sleep time (mean TST 6 hours 45 min) than women in a normative setting (mean of 7-7.5 hours of sleep) [57,58], a mean (subjective) sleep onset latency within the “normal” range (circa 20 minutes) [57], but a higher degree of wake time after sleep onset (objective - PSG) than both healthy controls as well as with primary insomnia subjects in a comparable study [59]. Total arousals at baseline in our sample were rather low compared with to this study [59]. Furthermore, the women participating in our study had higher daytime sleepiness scores at baseline as compared with a study in the general population [60].
The next step following this pilot study could take different paths. One track could be to continue with a similar three-arm design but with a larger sample size, in order to investigate the specific effects of TM. A second track would be to combine both TM and SC methods in one intervention and compare it to care as usual in a larger randomized controlled trial. We propose a simplified design where sleep diaries together with patient anamnesis and assessment of daytime sleepiness (ESS) can identify a homogenous sample (PSG can be added but is time consuming and expensive). For short and long term follow up of treatment effects, the diaries and the ESS seems sufficient measures. Speaking against a simplified design is that we (in the screening process) as well as others [61] noticed that a significant proportion of suspected of having primary insomnia based on clinical signs, actually had organic sleep disorders such as severe snoring, RLS, PLMS and OSAS.
On the basis of the findings, we can conclude that it is feasible to use the methods of TM and SC in the treatment of primary insomnia. Especially TM shows preliminary improvements in subjective measures of sleep, results which needs confirmation in full scale research. PSG appeared to be a good method in assuring that studied samples are homogenous, and thereby relevant to use as a method of excluding people with other causes of sleep problems. PSG appeared not to be a sensitive method in order to detect/confirm subjective measures of treatment effects of sleep variables in primary insomnia, at least not in comparison with the subjective scoring in the Karolinska Sleep Diary. These findings are supported in a study where it was concluded that PSG has a poor capacity to detect primary insomnia according to existing definitions [62].

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