Condition category
Mental and Behavioural Disorders
Date applied
09/07/2020
Date assigned
13/07/2020
Last edited
13/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

www.cektos.dk

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

Publication citations

Additional files

Editorial Notes

13/07/2020: Trial's existence confirmed by Cektos - Center for Metakognitiv Terapi.