InsomniaNCT02886052
Internet-based Cognitive Behavior Therapy for Insomnia for Parents Who Have Lost a Child
A study testing Therapist guided Internet-CBT for insomnia in people with Insomnia and Bereavement, run by Ersta Sköndal University College.
Trial summary
The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insomnia, Bereavement
- What is being tested?
- Therapist guided Internet-CBT for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia according to DSM-5
- Enough Swedish language skills
Who cannot join
- Other sleep disorders that require other treatment (e.g. sleep apnea)
- Somatic or psychiatric conditions requiring acute care
About this study
Official title: Therapist Guided Internet Cognitive Behavioral Therapy (ICBT) for Insomnia for Bereaved Parents: a Randomized Controlled Trial (RCT)
The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to evaluate changes in symptoms of complicated grief and depression.
- Conditions
- Insomnia, Bereavement
- Being tested
- Therapist guided Internet-CBT for insomnia, Active control
- Keywords
- Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, ICBT, CBT-i, Bereavement
- 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.
Therapist guided Internet-CBT for insomniaBehavioural
Active controlOther
| Study group | Role | What they receive |
|---|---|---|
| ICBT for insomnia | Experimental | Therapist guided Internet-CBT for insomnia Receives: Behavioral: Therapist guided Internet-CBT for insomnia |
| Active control | Active comparator | Written information on sleep, insomnia, and sleep hygiene Receives: Other: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in Insomnia Severity Index, ISI
7-item, self-rated questionnaire measuring change in insomnia severity.
Measured: 0, 9 and 18 months after treatment
Secondary outcomes (5)
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
The MADRS-S is a 9-item self-rated measure of change in depression severity.
Measured: 0, 9 and 18 months after treatment
Change (from baseline) in Prolonged Grief Disorder, PG-13
13-item, self-rated measure of prolonged grief disorder
Measured: 0, 9 and 18 months after treatment
Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5
20-item, self-rated measure of posttraumatic stress disorder
Measured: 0, 9 and 18 months after treatment
Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7
7-item, self-rated measure of anxiety symptoms
Measured: 0, 9 and 18 months after treatment
Change (from baseline) in Utrecht Grief Rumination Scale, UGRS
15-item, self-rated measure of grief rumination
Measured: 0, 9 and 18 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ersta Sköndal University College
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Region Stockholm
- Responsible party
- Principal investigator, Josefin Sveen, Ersta Sköndal University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886052
- Sponsor's protocol ID
- TJ2015-0021
- Status last verified
- Apr 2019
- First submitted
- 15 Aug 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapist Guided Internet Cognitive Behavioral Therapy (ICBT) for Insomnia for Bereaved Parents: a Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT02886052
- Acronym / sponsor ID
- TJ2015-0021
- Conditions
- Insomnia, Bereavement
- Keywords
- Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, ICBT, CBT-i, Bereavement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ersta Sköndal University CollegeUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Region Stockholm
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Sep 2016 (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 project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to evaluate changes in symptoms of complicated grief and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT for insomnia | Experimental | Behavioral: Therapist guided Internet-CBT for insomniaTherapist guided Internet-CBT for insomnia |
| Active control | Active comparator | Other: Active controlWritten information on sleep, insomnia, and sleep hygiene |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia according to DSM-5
- Enough Swedish language skills
Key exclusion criteria (2 listed)
- Other sleep disorders that require other treatment (e.g. sleep apnea)
- Somatic or psychiatric conditions requiring acute care
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 |
|---|---|---|
| Therapist guided Internet-CBT for insomnia | Behavioural | ICBT for insomnia |
| Active control | Other | Active control |
Primary outcome
Change (from baseline) in Insomnia Severity Index, ISI
Time frame: 0, 9 and 18 months after treatment
7-item, self-rated questionnaire measuring change in insomnia severity.
5 secondary outcomes
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
Time frame: 0, 9 and 18 months after treatment
Change (from baseline) in Prolonged Grief Disorder, PG-13
Time frame: 0, 9 and 18 months after treatment
Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5
Time frame: 0, 9 and 18 months after treatment
Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7
Time frame: 0, 9 and 18 months after treatment
Change (from baseline) in Utrecht Grief Rumination Scale, UGRS
Time frame: 0, 9 and 18 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist guided Internet-CBT for insomnia in people with Insomnia and Bereavement, run by Ersta Sköndal University College.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change (from baseline) in Insomnia Severity Index, ISI (time frame: 0, 9 and 18 months after treatment). 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 16 Apr 2019.