Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04290650 |
| Other study ID # |
50984 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
June 2021 |
| Source |
Oslo University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sleep disturbance is recognized as a major problem for patients with psychosis and is seen in
nearly all patients admitted in acute crisis to a psychiatric hospital.
Cognitive behavioral treatment is recommended as first-line treatment for insomnia in
national and international guidelines. This study explores effect of adapting the milieu
therapy to comply with the principles of CBT for insomnia. Our aim is to rethink our day to
day psychological interventions and our around the clock milieu therapy for patients with
acute and severe mental illness in light of established knowledge on how sleep is obtained
and maintained.
Description:
Sleep disturbances are highly prevalent among patients admitted to any hospital ward, but in
particular in psychiatric patients where insomnia and poor sleep quality is a major clinical
challenge.
Approximately 950 patients are admitted to The Acute Psychiatric Department at Oslo
University each year. The majority of the patients (approximately 450) admitted for more than
48 hours have a severe psychotic disorder and after being evaluated by a psychiatrist upon
admittance, they are allocated to one of three similar wards specialized in the treatment of
psychosis. A majority of the patients experience sleep difficulties both in terms of insomnia
and problems regulating circadian rhythm. Psychiatric wards in general offer several
challenges to sleep, including limited access to natural daylight, noisy environment and
frequent observations by staff during night for risk management purposes. A part from
offering medication which the patient often declines, staff members possess little means as
to how to cope with noise and agitation at night time due to frustrated patients unable to
find rest.
In September 2019 our department started organizing the treatment for psychotic patients in
three similar wards ("psychosis wards") and patients were allocated to a ward according to
their date of birth. Nurses are stationed permanently at each ward, while psychiatrist and
psychologists make up a "specialist pool" serving all three psychosis wards. One of the main
intentions for organizing the department and treatment this way is to ensure that all
patients with psychotic disorders receive the same treatment according to recommended
guidelines.
The aim of our study is to rethink our day to day psychological interventions and our around
the clock milieu therapy for our patients with acute and severe mental illness in light of
established knowledge on how sleep is obtained and maintained. After making physical
adjustments to the ward environment and training allocated nurses in modified CBT techniques,
the AkuSleep intervention will start up in March 2020 and will be carried out for up to six
months. All patients admitted one of the psychosis wards will be offered the same customized
treatment focusing on sleep, whereas all the patients admitted to the other two psychosis
wards will receive treatment as usual (TAU). Upon discharge, all patients admitted to the
Department of Acute Psychiatry who are able to give informed consent are asked to give a
broad consent allowing us to systemize clinical information from hospital records for
research purposes.
The AkuSleep protocol is as follows:
1. Identify the nature of the patient's sleeping problems and discuss suitable adjustments
with the patient. These adjustments would typically be to focus on circadian rhythm,
such as getting up in the morning at set times, avoiding coffee and strenuous physical
and emotional activities at night time, avoiding staying in bed when sleep is not
achieved and optimizing light/dark exposure. An acute ward setting such as ours is often
noisy and many of our patients have restrictions due to security reasons which limit the
access to natural day light. Simple physical measures will be implemented such as
providing ear plugs, providing night lamps so that staff don't need to turn on lights on
rounds, secure speakers so that the patients may listen to soothing music, easy blinds
to secure a dark room at night and bean bags (or chairs) in every room so that the
patient can get out of bed when sleep is not achieved. The use of daylight lamps will be
offered for patients who due to security reasons or otherwise are denied access to
natural daylight.
2. Trained nurses will perform a short 20 minute daily session with the patient addressing
tailored measures in accordance with the modified CBT for insomnia. Assessment of the
individual patient's specific sleeping problems is vital for an effective treatment.
Sleeping problems/disorders typically falls in to three categories; disturbance in the
sleep/wake homeostasis, disturbance in the circadian rhythm and/or hyperarousal.
Detecting the nature of the sleeping disorder, maintenance factors and individual goals
for treatment will give way to a sleep-focused case formulation that will guide further
strategies. The use of sleep and activity monitoring devices will be offered for those
who find it useful. Information from monitoring devices will be used for the purpose
psychoeducation and as basis for the sleep diary and relevant information will be
registered in the clinical records. Data from monitoring devices will not be stored
electronically. Intentions available for the patient and therapist are gathered from CBT
for insomnia and will involve establishing a firm associations between bed and sleep
through the use of stimulus control and the setting of a consistent sleep window (time
spent in bed); activity scheduling to promote good wake-up routines and help build up
necessary sleep pressure; targeting hyperarousal through systematic wind-down
strategies, relaxation training etc. Psychotic symptoms such as hallucinations and
delusions are also prone to give disturbance in the ability to either getting to or
staying asleep. These symptoms will be incorporated in the specific formulation for
treatment and management of the symptoms will be a part of later strategies promoting
good sleep hygiene. The implemented measures will be monitored and evaluated throughout
the whole period so that adjustments can be made on a daily basis and in accordance with
the formulation and the patient's goals. The details of the individual treatment
progress will be written in a patient owned workbook, giving all trained staff members
an opportunity to step in at any time to continue the therapeutic work. The workbook
will be given to the patient at their time of discharge with instructions of further
use.
The teaching of the nursing staff will cover topics to enable them to give psychoeducation
about the function and the architecture of sleep, to assess sleep quality and disturbance and
to create a case formulation. Nursing staff will be trained in specific cognitive techniques
that target night time worries and the handling of hallucinations/voices. The interventions
will be manualized, securing equality in treatment for all patients. A clinical psychologist
with CBT training, stationed at the ward, will take part in the initial assessment and will
offer support in the creating the case formulation. The standardized evaluation using symptom
checklists and sleep checklists will also be conducted by the psychologist or doctor in
charge. Supervision will be given in groups led by a clinical psychologist on a weekly basis
as well as ad hoc troubleshooting and problem solving on a daily basis. The individual
treatment will include an activity plan for each patient prepared in close collaboration with
our wards occupational therapist concerning. This will involve good wake up routines and
winding down-routines, light exposure to reestablish circadian rhythm and activating
activities to counteract the need for daytime naps that disturbs the build-up of sleep
pressure. Much of the described measures are already part our established inpatient nursing
services or "treatment as usual". The focus of our project, however, will be to systemize
these interventions in light of a 24 hour cycle aimed specifically to target the promotion of
good sleep. Before discharge, the psychologist or doctor in charge will conduct a
reevaluation using symptom checklist as well as an interview focusing on lessons learned and
tool acquired by our patients struggling with chronic sleep disturbances in how to cope with
these challenges after their discharge.
All patients on all three psychosis wards will receive standard evidence based treatment for
psychosis and affective disorders as per today. All patients on the two wards not receiving
the treatment protocol will also be offered to wear a monitoring device on order to register
potential sleep disturbances. All patients who choose to wear a monitoring device, will be
offered a psychoeducative session with a psychologist trained in CBT upon discharge.
Primary outcome will be the quantity and quality of sleep as measured by clinical records on
sleep duration, sleep onset, number of awakenings, bed time, rise time and medication used.
Secondary outcomes will be symptom load as measured by clinical records of nursing category
(PK) and Brøset Violence Checklist (BVC), symptom measurements for psychosis (PANSS), for
mania (YMRS) and global assessment of function (GAF). In addition daily dosage of medication
such as antipsychotics, mood stabilizers, benzodiazepines and sleep inducing medication, as
well as registered aggressive events will be measured. In most cases the patient is admitted
involuntary and time until their legal status is changed from involuntary to voluntary will
be calculated as a measurement of insight and health improvement. Finally, average number of
bed days, ward level of violence and wards cost of medication for the three wards will be
calculated and compared for all patients admitted during the study period.
Patients admitted to an acute psychiatric ward are very often not able to give informed
consent upon admittance due to psychotic symptoms. Those who are able to give informed
consent upon discharge will be asked to sign a broad consent. For those patients who consent
upon discharge, data will be gathered for all patients on all three psychosis wards and
compared against each other. Aggregated and anonymized data will be gathered and compared
across the three wards. We have estimated that 90 (45+45) participants are required in order
to meet our aims. In order to provide an answer as to whether this treatment is cost
effective for the department by comparing total number of bed days, ward level of violence
and wards cost of medication, we have calculated that we need a larger sample size of
approximately 200 (100+100). We have implemented the broad consent at the Department of Acute
Psychiatry and based on our experience, only 30-40 % of the patients choose to or are able to
consent to research even when they are stable. We therefore expect that the intervention
period will go on for approximately 6 months in order to achieve the number needed.
Due to the corona outbreak, the inclusion of patients for the AkuSleep study has been
postponed indefinitely. The ward that was dedicated to the intervention has been transformed
to a specialized unit treating psychiatric patients with either known COVID-19 or having
symptoms of COVID-19. The study will start including patients when the Norwegian Health
authorities have declared the outbreak to be under control and the ward is again offering
standard treatment to patients with psychotic disorders.
