The current project aims to assess both the effectiveness and cost-effectiveness of an internet-based insomnia intervention (i-Sleep) in addition to usual care for depression, compared to usual care alone, in depressive patients with comorbid…
ID
Source
Brief title
Condition
- Other condition
- Sleep disorders and disturbances
Synonym
Health condition
depressieve stemmingstoornis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in depressive symptoms within patients
at 3, 6, 9 and 12 months of follow-up, as well as the difference between
intervention and control groups. This will be assessed with the Patient Health
Questionnaire-9 (PHQ-9).
Secondary outcome
Secondary outcomes are insomnia severity (Insomnia Severity Index, ISI), daily
functioning (Work and Social Adjustment Scale, WSAS), general quality of life
(EuroQol 5-level version, EQ-5D-5L), lost productivity costs (adapted version
of the iMTA Productivity Cost Questionnaire, iPCQ) and healthcare, patient and
family costs (adapted version of the iMTA Medical Cost Questionnaire, iMCQ).
Background summary
Patients with unipolar depression often simultaneously meet the DSM-5 criteria
for insomnia disorder. These patients have significantly lower quality of life
and worse treatment outcomes than depressive patients without insomnia. While
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the treatment option of
first choice, insomnia is currently, if recognized accurately, often treated
pharmacologically. A pilot study has already shown that the online CBT-I
intervention i-Sleep could potentially serve as a relatively easily accessible
addition to the usual care for depression. However, a randomized controlled
trial evaluating the effectiveness and cost-effectiveness of adding i-Sleep to
usual care among depressed patients treated in specialized mental healthcare
has not yet been performed. We hypothesize that addition of i-Sleep to usual
care will result in a significant improvement in depression treatment outcomes
and quality of life as well as a decrease in healthcare and societal costs,
compared to usual care alone.
Study objective
The current project aims to assess both the effectiveness and
cost-effectiveness of an internet-based insomnia intervention (i-Sleep) in
addition to usual care for depression, compared to usual care alone, in
depressive patients with comorbid insomnia treated at a specialized mental
healthcare outpatient clinic. Furthermore, a process evaluation of implementing
i-Sleep in daily clinical practice will take place.
Study design
This study is a multi-centre randomized controlled trial with randomisation at
the patient level with 12 months of follow-up.
Intervention
i-Sleep is a guided, internet-based cognitive behavioural therapy for insomnia,
which will be added to usual care for depression in specialized mental
healthcare. The i-Sleep program consists of 5 online sessions: 1)
psycho-education on sleep, sleep disorders and sleep hygiene, 2) sleep
restriction and stimulus control training, 3) rumination and relaxation
techniques, 4) cognitive restructuring, 5) relapse prevention. The i-Sleep
module is offered prior to the start of usual care for depression, in a blended
format.
Study burden and risks
The sole burden of participating in this trial will be adhering to the program,
i.e. completing assignments and questionnaires. There are no known serious
risks associated with the investigational treatment, although patients may
experience side effect of the treatment due to sleep restriction, e.g. fatigue,
daytime sleepiness, loss of motivation/energy and headaches.
De Boelelaan 1117-1118
Amsterdam 1081 HV
NL
De Boelelaan 1117-1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
• 18 years or older with a maximum age of 75 years,
• Scheduled for treatment of unipolar depression according to the DSM-5
criteria at one of the abovementioned specialized mental healthcare outpatient
clinics,
• Fulfilling the DSM-5 criteria for insomnia disorder.
Exclusion criteria
• Insufficient command of the Dutch language,
• Working night shifts,
• Sleep-related conditions other than insomnia, e.g. sleep apnoea,
• No daily access to an internet-connected computer,
• Presence of a mental health crisis situation.
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 | NL73477.029.20 |
| OMON | NL-OMON22668 |