Plain English Summary
Background and study aims
Insomnia is defined by the presence of long sleep latency (the time it takes to get to sleep), frequent nocturnal awakenings or prolonged periods of wakefulness during the sleep period. Insomnia has severe consequences for individuals’ quality of life, and healthcare expenditures are about 160% of people without insomnia. The aim of this study is to test the effectiveness of a psychological therapy called metacognitive therapy for insomnia.
Who can participate?
Patients with insomnia
What does the study involve?
Participants are randomly alloacted to either up to 10 sessions of metacognitive therapy or a 12 week waiting-list control group. Participants are assessed on insomnia severity, anxiety, depression, time spend worrying and metacognitive beliefs before treatment, after treatment and at 6 and 12 months follow-up.
What are the possible benefits and risks of participating?
There are no previously reported risks of metacognitive therapy. Participants can withdraw from the trial at any time without any reasons. If any participants' condition deteriorates whilst being in the metacognitive therapy they are referred to psychiatric care.
Where is the study run from?
Cektos - Center for Metakognitiv Terapi (Denmark)
When is the study starting and how long is it expected to run for?
July 2020 to July 2022
Who is funding the study?
Cektos - Center for Metakognitiv Terapi (Denmark)
Who is the main contact?
Dr Pia Callesen
pia.callesen@cektos.dk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Pia Callesen
ORCID ID
https://orcid.org/0000-0001-5087-7095
Contact details
Oxford Alle 66
Copenhagen
2300
Denmark
+45 (0)22684281
pia.callesen@cektos.dk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Metacognitive therapy for insomnia: a randomised controlled trial
Acronym
MCTINSOMNIA
Study hypothesis
The alternative hypothesis of this study states that Metacognitive Therapy (MCT) for insomnia will result in a statistically significant positive change in patient symptoms of insomnia compared to a waiting-list control group receiving no treatment for 12 weeks.
Ethics approval
Approval pending, Danish Ethics Board (Den Videnskabsetiske Komité for Region Sjælland, Alléen 15, 4180 Sorø, Denmark; +45 (0)93 56 60 00; RVK-sjaelland@regionsjaelland.dk), ref: 74316
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Insomnia
Intervention
Randomisation is achieved using a random number generator. The treatment group receive up to 10 sessions of MCT and a waiting list control group receive MCT after 12 weeks waiting time. Assessment is made at pre, post and finally at 6 and 12 months follow-up with primary and secondary variables.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Insomnia severity measured using Insomnia Severity Index (ISI) before treatment, after approximately 12 weeks treatment (10 sessions) and at 6 and 12 months follow-up
Secondary outcome measures
Anxiety and depressive symptoms measured using hospital anxiety and depression scale (HADS) before treatment, after approximately 12 weeks treatment (10 sessions) and at 6 and 12 months follow-up
Overall trial start date
01/07/2020
Overall trial end date
01/07/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients suffering from insomnia as measured on the ISI
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
26
Participant exclusion criteria
Patients are excluded if they:
1. Suffer from severe depression, anxiety or psychosis
2. Report any suicidality
3. Have sleep disruptive medical illnesses
Recruitment start date
22/06/2020
Recruitment end date
22/06/2022
Locations
Countries of recruitment
Denmark
Trial participating centre
Cektos - Center for Metakognitiv Terapi
Riddergade 7, 1 sal
Næstved
4700
Denmark
Sponsor information
Organisation
Cektos - Center for Metakognitiv Terapi
Sponsor details
Riddergade 7
1 sal
Næstved
4700
Denmark
+45 (0)55734849
info@cektos.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Cektos - Center for Metacognitiv Terapi
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer-reviewed journal. All documents are available on request.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
22/06/2023
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list