Testing the effect of metacognitive therapy for insomnia

ISRCTN	ISRCTN85892563
DOI	https://doi.org/10.1186/ISRCTN85892563

Submission date: 09/07/2020
Registration date: 13/07/2020
Last edited: 11/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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 receive up to 10 sessions of metacognitive therapy. Participants are assessed on insomnia severity, anxiety, depression, time spent 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 giving a reason. 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 September 2024

Who is funding the study?
Cektos - Center for Metakognitiv Terapi (Denmark)

Who is the main contact?
Dr Pia Callesen
pia.callesen@cektos.dk

Study website

Contact information

Dr Pia Callesen
Scientific

Oxford Alle 66
Copenhagen
2300
Denmark

ORCID ID	0000-0001-5087-7095
Phone	+45 (0)22684281
Email	pia.callesen@cektos.dk

Study information

Study design	Open trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Metacognitive therapy for insomnia: a randomised controlled trial
Study acronym	MCTINSOMNIA
Study objectives	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(s)	1. Approved 23/11/2020, Den Videnskabsetiske Komité for Region Sjælland (Sekretariatet for Den Regionale Videnskabsetiske Komité Alléen 15 , Sorø, 4180, Denmark; +45 (0)5787 5283; rvk-sjaelland@regionsjaelland.dk), ref: SJ-872 - EMN-2020-35209 2. Approved 03/02/2021, 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
Health condition(s) or problem(s) studied	Insomnia
Intervention	Current interventions as of 30/08/2023: Patients receive up to 10 sessions of MCT. Assessment is made at pre, post and finally at 6 and 12 months follow-up with primary and secondary variables. Previous interventions: 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
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 study start date	01/07/2020
Completion date	06/09/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	26
Key inclusion criteria	Patients suffering from insomnia as measured on the ISI
Key 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
Date of first enrolment	22/06/2020
Date of final enrolment	01/09/2022

Locations

Countries of recruitment

Denmark

Study participating centre

Cektos - Center for Metakognitiv Terapi

Riddergade 7, 1 sal
Næstved
4700
Denmark

Sponsor information

Cektos - Center for Metakognitiv Terapi
Hospital/treatment centre

Riddergade 7, 1 sal
Næstved
4700
Denmark

Phone	+45 (0)55734849
Email	info@cektos.dk
Website	www.cektos.dk

Funders

Funder type

Hospital/treatment centre

Cektos - Center for Metacognitiv Terapi

No information available

Results and Publications

Intention to publish date	31/12/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high impact peer-reviewed journal. All documents are available on request.
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

11/09/2024: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2024 to 06/09/2024.
2. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
14/06/2024: The intention to publish date was changed from 22/06/2024 to 31/12/2024.
30/08/2023: The following changes were made to the trial record:
1. Ethics approval details, study website and lower age limit added.
2. The study design was changed from 'Randomized controlled trial' to 'Open trial'.
3. The overall study end date was changed from 01/09/2023 to 01/09/2024.
4. The interventions were updated.
15/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 22/06/2022 to 01/09/2022.
2. The overall trial end date was changed from 01/07/2022 to 01/09/2023.
3. The intention to publish date was changed from 22/06/2023 to 22/06/2024.
23/03/2021: Ethics approval details added.
13/07/2020: Trial's existence confirmed by Cektos - Center for Metakognitiv Terapi.