Erik Roj Larsen

Objective: The objective of this review was to identify and synthesize the best available evidence on how adult patients experience living with depression-related insomnia, and their experiences related to pharmacological and non-pharmacological interventions aimed at improving sleep. Introduction: Insomnia affects 80% to 90% of patients with depression. The costs of insomnia are considerable for the individual and society alike. To understand the role and consequences of insomnia for an individual with depression and to optimize sleep interventions, an in-depth understanding of patients’ experiences is needed. Therefore, this review addresses how adult patients experience living with depression-related insomnia, along with their experiences of pharmacological and non-pharmacological sleep interventions. Inclusion criteria: Studies focusing on adult patients aged 18 years and older with a diagnosis of depression who had experiences with insomnia and pharmacological and/or non-pharmacological sleep interventions were included. All studies with qualitative research findings from inpatient and outpatient populations were considered. Methods: The following databases were searched: MEDLINE (PubMed), Embase, CINAHL (EBSCOhost), PsycINFO (ProQuest), Cochrane CENTRAL, SveMed+, Scopus, and Web of Science Core Collection. Google Scholar and ProQuest Dissertations and Theses were searched for eligible dissertations and theses. The searches were conducted on May 3–5, 2022, and updated on June 13–19, 2023. Studies published in English, Danish, German, Norwegian, and Swedish were considered. Databases were searched from their inception to the search date. All studies were screened against the inclusion criteria, and critically and independently appraised by 2 reviewers for methodological quality. Findings were pooled using meta-aggregation, and a ConQual Summary of Findings was created. Results: Ten qualitative studies were included. The studies were conducted in 6 countries and counted a total of 176 participants. In all, 127 findings were extracted and aggregated into 11 categories. From the 11 categories, 3 synthesized findings were developed: i) Disruption of sleep challenges coping with everyday life by depleting both physical and mental resources; ii) Sleep is an escape and a protective factor against suicide; and iii) Choices, support, and personalized interventions from non-pharmacological approaches addressing depression-related insomnia are valued. Conclusions: This review underlined the relationship between depression-related insomnia, its profound impact on individuals’ lives, and the value of non-pharmacological sleep interventions to address these issues. Specifically, the review revealed the physical and emotional consequences of insomnia while emphasizing how wakefulness during night hours may exacerbate feelings of loneliness and vulnerability to negative thoughts and suicide. Moreover, it provides an overview of patients’ experiences of non-pharmacological approaches to address depression-related insomnia and highlights their diverse treatment experiences and preferences. Supplemental digital content: A Danish-language version of the abstract of this review is available as supplemental digital content: http://links.lww.com/SRX/A64. Review registration: PROSPERO CRD42021276048

Insomnia is prevalent in patients suffering from depression and may itself exacerbate the disability associated with depression and impede the path to recovery. Although crucial in ensuring meaningful interactions and interventions for patients, research on patients' experiences of depression-related insomnia and its treatment is limited. The purpose of this study was therefore to investigate how adult patients with depression-related insomnia experience sleeping with a weighted Protac Ball Blanket®, focusing on how the blanket feels and works and contributes to their subjective sleep quality experience. An inductive content analysis approach was adopted. Semi-structured interviews were conducted with 13 patients. Four categories were identified: 1) Deep and dynamic touch pressure from the plastic balls induced calmness; 2) Changing sensory impressions from the rolling balls distracted attention from distressing thoughts and emotions; 3) The ball blanket improved the quality and quantity of sleep, which increased daily well-being; 4) Sleeping with the ball blanket was associated with positive as well as negative experiences depending on personal preferences for sensory stimulation. This study explains how the Protac Ball Blanket® as a potential non-pharmacological sleep-intervention improved the sleep of adult patients with depression-related insomnia. The blanket was found meaningful for coping with sleeplessness and with mental and physical unrest.

Introduction: Service users are increasingly participating in health research. Although collaborative research is assumed to give users a sense of psychological ownership, little is known about the specific psychosocial processes through which ownership develops and is displayed. The present study yields insight into a process in which service users, researchers and a website designer collaborated to design a website.Aim: The aim of this study was to explore how participants developed and displayed feelings of ownership during a collaborative process to design a website.Methods: A case study design was adopted by which audio recordings were subjected to thematic analysis and interpreted by drawing on the concept of psychological ownership.Findings: A sense of psychological ownership of the website design process emerged in two distinct and overlapping phases. In the first phase, ‘sense of ownership during the early design phase’, only researchers and the website designer displayed a sense of ownership, which was facilitated by the research context preceding the collaborative workshops. In the second phase, ‘sense of ownership during the collaborative design phase’, service users gradually started to develop parallel feelings of ownership that were facilitated by workshop design activities. These activities enabled service users to increasingly control the process, to invest themselves in the process and to gain intimate knowledge of the process and its outcome. Service users' sense of ownership was displayed in their statements about the website and its elements.Conclusion: Participants engaged in codesign processes may develop a sense of psychological ownership at different speeds because of contextual factors. It is important to take this into account as it may complicate the formation of egalitarian work groups.Patient and Public Contribution: Parents of children with suicidal behaviour and a counsellor participated as service users in a website design process.

The aim of this randomised controlled assessor-blinded trial was to examine the effect of cognitive behavioural therapy for insomnia on sleep variables and depressive symptomatology in outpatients with comorbid insomnia and moderate to severe depression. Forty-seven participants were randomized to receive one weekly session in 6 weeks of cognitive behavioural therapy for insomnia or treatment as usual. The intervention was a hybrid between individual and group treatment. Sleep scheduling could be especially challenging in a group format as patients with depression may need more support to adhere to the treatment recommendations. The primary outcome measure was the Insomnia Severity Index. Secondary measures were sleep diary data, the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire, the Hamilton Depression Rating Scale, and the World Health Organization Questionnaire for Quality of Life and polysomnography. Compared to treatment as usual, cognitive behavioural therapy significantly reduced the insomnia severity index (mean ISI 20.6 to 12.1, p = 0.001) and wake after sleep onset (mean 54.7 min to 19.0 min, p = 0.003) and increased sleep efficiency (mean SE 71.6 to 83.4, p = 0.006). Total sleep time and sleep onset latency were not significantly changed. The results were supported by analyses of the other rating scales and symptom dimensions. In conclusion, cognitive behavioural therapy for insomnia as add-on to treatment as usual was effective for treating insomnia and depressive symptoms in a small sample of outpatients with insomnia and major depression. ClinicalTrials.gov Identifier: NCT02678702.

Background: The treatment of mania in bipolar disorders needs to be more efficient, as the manic condition creates severe problems for the patient when it comes to work, finances, relationships and health. This proof-of-concept study examines to what extent casein glycomacropeptide (CGMP) may reduce the precursors of dopamine, phenylalanine and tyrosine, in plasma, and therefore be a potential new intervention to treat acute manic episodes.Method: The study was designed as a double-blind randomised dose–response study of CGMP (with added leucine and tryptophan) in 15 healthy men, receiving 3 different doses of CGMP with an interval of at least 14 days.Results: Administration of CGMP produced a dose-dependent depletion of plasma aromatic amino acids. The total area under the curve of plasma ratios of phenylalanine–tyrosine compared to the level of leucine–isoleucine–valine–-tryptophan was CGMP (20 g): 3.648 [SE:0.3281]; CGMP (40 g): 2.368 [SE:0.1858]; and CGMP (60 g)1.887 [SE:0.2591]. A comparison of the groups showed a dose-dependent statistical difference, with a one-way ANOVA summary (Dunnett) F = 11.87, p = 0.0003, CGMP 20 g versus CGMP 40 g, p = 0.0042, CGMP 20 g versus CGMP 60 g, p = 0.0002. No significant side effects were observed.Conclusions: This study demonstrate CGMP is a well-tolerated and effective mixture, and that 60 g of CGMP produced the highest depletion of plasma aromatic amino acids (phenylalanine and tyrosine). The effect seems to be highest after 3–4 h. We therefore conclude that this dose should be the one considered for future studies involving CGMP in humans.

Background: Depression affects approx. 4% of the global population and is often accompanied by insomnia. Medications used to treat insomnia can have side effects such as development of tolerance and addiction. The Protac Ball Blanket™ (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented. The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design. Methods: This study is a multicentre, randomized crossover trial with planned inclusion of 45 patients. The randomization procedure is permuted-block randomization with varying block sizes. Patients are allocated into either a sequence “AB” or “BA” each lasting 4 weeks (28 nights). Patients randomized to the “AB” sequence receive treatment A (Protac Ball Blanket™) in the first 2 weeks and switch to treatment B (treatment as usual) in the second period, whereas patients who are randomized to the BA sequence receive treatment B in the first period and treatment A in the second period. The participants will serve as their own control in this design. The primary outcome is changes in total sleep time. Secondary outcome measures are changes in sleep onset latency, number of awakenings, wake after sleep onset, and use of sedatives and hypnotics. Furthermore, quality of sleep, insomnia severity status, and self-reported symptoms of depression, anxiety, interpersonal sensitivity, and neurasthenia will be measured. A paired, two-sided t test to compare the means of the differences in the outcomes will be performed. Discussion: This clinical trial will assess the effect of PBB on depression-related insomnia. The outcomes are of high interest as the PBB is a potential non-pharmacological supplement to medical treatment of patients with insomnia due to depression. Trial registration: ClinicalTrials.gov Identifier: NCT03730974. Registered on 5 November 2018.

Background.: The efficacy of antidepressant treatment is fair, but the efficacy is considerably lower in patients failing two or more trials underscoring the need for new treatment options. Our study evaluated the augmenting antidepressant effect of 8-weeks transcranial pulsed electromagnetic field (T-PEMF) therapy in patients with treatment-resistant depression.Methods.: A multicenter 8-week single-arm cohort study conducted by the Danish University Antidepressant Group.Results.: In total, 58 participants (20 men and 38 women) with a moderate to severe depression as part of a depressive disorder according to ICD-10 who fulfilled criteria for treatment resistance were included, with 19 participants being nonresponders to electroconvulsive therapy during the current depressive episode. Fifty-two participants completed the study period. Scores on the Hamilton Depression Scale 17-items version (HAM-D₁₇) decreased significantly from baseline (mean = 20.6, SD 4.0) to endpoint (mean = 12.6, SD 7.1;N = 58). At endpoint, utilizing a Last Observation Carried Forward analysis, 49 and 28% of those participants with, respectively, a nonchronic current episode (≤2 years;N = 33) and a chronic current episode (>2 years;N = 25) were responders, that is, achieved a reduction of 50% or more on the HAM-D₁₇scale. At endpoint, respectively, 30 and 16% obtained remission, defined as HAM-D₁₇ ≤ 7. On the Hamilton Scale 6-item version (HAM-D₆₎, respectively, 51 and 16% obtained remission, defined as HAM-D₆ ≤ 4.Conclusions.: The findings indicate a potential beneficial role of T-PEMF therapy as an augmentation treatment to ongoing pharmacotherapy in treatment-resistant depression.