Secondary InsomniaNCT00235365
Metacognitive Therapy for Comorbid Insomnia
A study testing meta-cognitive therapy and waiting list in people with Secondary Insomnia, run by Norwegian University of Science and Technology.
Trial summary
The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Secondary Insomnia
- What is being tested?
- meta-cognitive therapy and waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Insomnia secondary to a primary psychiatric disorder
Who cannot join
- substance abuse, psychotic symptoms, suicidal intentions, severe organic disorder or psychiatric disorder where sleep restriction is not advised, organic sleep disorder.
About this study
Official title: Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia.
The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia.
Read the detailed description
This study is a randomized controlled trial with 50 patients with a psychiatric disorder and insomnia. The patients will be randomized into two groups of 25 patients. The first group receives meta-cognitive therapy, whereas the second group will be assigned to a waiting list control.
- Conditions
- Secondary Insomnia
- Being tested
- meta-cognitive therapy, waiting list
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meta-cognitive therapyBehavioural
Meta-cognitive therapy
waiting listOther
waiting list control
| Study group | Role | What they receive |
|---|---|---|
| meta-cognitive therapy | Experimental | meta-cognitive therapy Receives: Behavioral: meta-cognitive therapy |
| waiting list | Active comparator | waiting list control Receives: Other: waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on rating scales for sleep quality
Measured: one year
Secondary outcomes (1)
Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: problems recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Morken, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235365
- Sponsor's protocol ID
- S2005.2.gr
- Status last verified
- Nov 2012
- First submitted
- 7 Oct 2005
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Therapy for Patients With a Psychiatric Disorder and Comorbid Insomnia.
- ClinicalTrials.gov ID
- NCT00235365
- Acronym / sponsor ID
- S2005.2.gr
- Conditions
- Secondary Insomnia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: problems recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of meta-cognitive therapy for insomnia.
Detailed description
This study is a randomized controlled trial with 50 patients with a psychiatric disorder and insomnia. The patients will be randomized into two groups of 25 patients. The first group receives meta-cognitive therapy, whereas the second group will be assigned to a waiting list control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| meta-cognitive therapy | Experimental | Behavioral: meta-cognitive therapymeta-cognitive therapy |
| waiting list | Active comparator | Other: waiting listwaiting list control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Insomnia secondary to a primary psychiatric disorder
Key exclusion criteria (1 listed)
- substance abuse, psychotic symptoms, suicidal intentions, severe organic disorder or psychiatric disorder where sleep restriction is not advised, organic sleep disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meta-cognitive therapyMeta-cognitive therapy | Behavioural | meta-cognitive therapy |
| waiting listwaiting list control | Other | waiting list |
Primary outcome
Scores on rating scales for sleep quality
Time frame: one year
1 secondary outcome
Scores on rating scales for depression, psychiatric symptom severity, and cognitive processing.
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Morken, PhD MD principal investigator
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing meta-cognitive therapy and waiting list in people with Secondary Insomnia, run by Norwegian University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on rating scales for sleep quality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.