This study aims to transdiagnostically evaluate effectiveness of guided Internet CBT for insomnia (ICBTI) to improve sleep, reduce emotional distress and improve responsiveness to regular treatment through sleep improvement, and to foster…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric and behavioural symptoms NEC
Synonym
Health condition
insomnie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the RCT is the insomnia severity. Insomnia Severity is
measured with the Insomnia Severity Index (ISI). For the study with subjects
with borderline personality disorder, the amount of BPD symptoms is the primary
outcome measure, this is measured with the Borderline Personality Disorder
Severity Index (BPDSI).
Secondary outcome
Secondary outcomes address three domains: sleep, mental health, and daytime
functioning and well-being. They include I) other indicators of sleep and
overnight alleviation of distress assessed from a sleep diary kept online for a
week and from headband EEG assessed at home for four nights within that week
(unless participant decides not to take part in the EEG assessments); II) the
severity of mental health complaints characterizing different diagnostic
dimensions, as well as well-being and daytime functioning including health
behaviors and use of care, all assessed by online surveys at T0, T1 (2 months)
and T2 (8 months). For the study with subjects with borderline personality
disorder an additional clinical interview is done at T0, T1 (2 months) and T2
(8 months). Qualitative assessment of experiences with the intervention in a
sub-sample of participants (process evaluation interviews)
Background summary
Emotional distress and mental health complaints are among the most common and
burdensome problems for individuals and society. One in five people experience
the problems so severely at least once in their life that a psychiatric
diagnosis is warranted. The persistence of these diagnoses is evident from the
12-month prevalence of near one in five people. Especially frequent (17.3%) are
diagnoses characterized by inadequate regulation of emotional distress,
including anxiety disorders, post-traumatic stress disorder and borderline
personality disorder. Regular treatment does not suit everyone well, and after
recovery, relapse often occurs. Therefore, it is urgent to prevent first-onset
of psychiatric disease, and improve treatment efficacy. Attention to insomnia
offers the best chance to do so. Insomnia is a primary risk factor for most
mental disorders. Insomnia is also the transdiagnostically most commonly shared
complaint across mental disorders. Unfortunately, regular treatment does not
explicitly address insomnia. This situation is disquieting because good sleep
is essential for regulating emotions and learning new cognitions and behaviours
- the core fundaments of regular cognitive behavioural therapy (CBT) for mental
disorders.
Study objective
This study aims to transdiagnostically evaluate effectiveness of guided
Internet CBT for insomnia (ICBTI) to improve sleep, reduce emotional distress
and improve responsiveness to regular treatment through sleep improvement, and
to foster implementation of ICBTI through a process evaluation.
Study design
This study is a transdiagnostic randomized controlled trial with stratified
randomisation at the participant level. As a pragmatic (or practical) clinical
trial (PCT), the study is performed in a way that allows for immediate upscaled
implementation in real-world practice, in case the intervention proves
effective. The study additionally entails a mixed-method process evaluation.
Intervention
ICBTI is a guided, internet-based cognitive behavioural therapy program for
insomnia, and consists of five online sessions:
1. Psycho-education
2. Sleep restriction
3. Rumination and relaxation techniques
4. Cognitive restructuring
5. Relapse prevention
Study burden and risks
The sole burden of participating in this trial will be adhering to the program,
i.e. completing assignments and assessments. There are no known serious risks
associated with the investigational treatment, although participants may
temporarily experience side effects of the treatment due to sleep restriction,
e.g. fatigue, daytime sleepiness, loss of motivation/energy and headaches. It
is hypothesized that participants randomized to the active condition will
experience some improvement of their sleep and if so, a more favourable
progress of their mental health symptoms. Participants motivated to participate
but uncomfortable with EEG-assessments will not be excluded. The additional
process evaluation interview is only conducted on a sub-sample of all
participants and is optional, so participants will only commence in the
interview if they are willing to.
Oldenaller 1
amsterdam 1081 HJ
NL
Oldenaller 1
amsterdam 1081 HJ
NL
Listed location countries
Inclusion criteria
18 years or older
Insomnia Severity Index score >=10
Self-considered capability of completing online questionnaires and diaries in
Dutch.
Clinically relevant mental health complaints according to the Rapid Measurement
Toolkit 20-item (RMT-20) questionnaire cut-offs in at least one of its
dimensions of PTSD (>=8), Social Anxiety Disorder (>=12), Panic disorder (>=9) or
Generalized Anxiety Disorder (>=11), or according to the Ultrashort BPD
Checklist (BPD-C) indicated by a score >=14. Patients recruited through GGZ are
required to be diagnosed with an anxiety disorder according to the MINI or BPD
diagnosis (or other personality disorder with at least 4 BPD traits of which at
least one of the following traits: *affective instability*, *impulsivity*,
*parasuicidal behavior*, *anger attacks*, according to the SCID-5-P.
Exclusion criteria
The main exclusion criteria are based on the probable inability to comply with
ICBTI instructions and the assessments, as we expect to occur in people
currently diagnosed with bipolar disorder, psychotic disorder, and alcohol or
substance dependency. Potential participants that underwent CBT-I treatment in
the last 3 months will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76232.029.21 |
| OMON | NL-OMON21458 |