Complicated GriefNCT02519569
Internet-based Intervention for Complicated Grief: A Pilot Study
A study testing Internet-based cognitive-behavioral therapy in people with Complicated Grief, run by University of Tromso.
Trial summary
A considerable proportion of bereaved individuals experience chronic and disabling grief (so-called complicated or prolonged grief). Complicated grief is associated with severe mental and physical health problems as well as impaired social and occupational functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Grief
- What is being tested?
- Internet-based cognitive-behavioral therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complicated grief
- Internet access
- Fluent in Norwegian
- No concomitant psychological treatment
Who cannot join
- Severe depression
- Psychotic symptoms
- Dissociation
- Suicidality
Trial locations and contacts
No sites are listed yet.
About this study
A considerable proportion of bereaved individuals experience chronic and disabling grief (so-called complicated or prolonged grief). Complicated grief is associated with severe mental and physical health problems as well as impaired social and occupational functioning. Interventions based on cognitive-behavioral therapy and applied via the internet have shown to be efficacious for this condition, but have not yet been adapted and evaluated in Norway. The aim of the current study is to adapt an internet-based cognitive-behavioral intervention for complicated grief and evaluate its effectiveness as a pilot study.
- Conditions
- Complicated Grief
- Being tested
- Internet-based cognitive-behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive-behavioral therapyOther
The intervention consists of ten writing assignments
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Internet-based cognitive-behavioral therapy for complicated grief Receives: Other: Internet-based cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pretest to posttest in symptoms of complicated grief
Measured: 6 weeks
Change from pretest to follow-up (1) in symptoms of complicated grief
Measured: 18 weeks
Change from pretest to follow-up (2) in symptoms of complicated grief
Measured: 30 weeks
Secondary outcomes (9)
Change from pretest to posttest in posttraumatic growth
Measured: 6 weeks
Change from pretest to follow-up (1) in posttraumatic growth
Measured: 18 weeks
Change from pretest to follow-up (2) in posttraumatic growth
Measured: 30 weeks
Change from pretest to posttest in quality of life
Measured: 6 weeks
Change from pretest to follow-up (1) in quality of life
Measured: 18 weeks
Change from pretest to follow-up (2) in quality of life
Measured: 30 weeks
Change from pretest to posttest in depression
Measured: 6 weeks
Change from pretest to follow-up (1) in depression
Measured: 18 weeks
Change from pretest to follow-up (2) in depression
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated GriefStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Thimm, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519569
- Sponsor's protocol ID
- 2015/388(REK)
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Intervention for Complicated Grief: A Pilot Study
- ClinicalTrials.gov ID
- NCT02519569
- Acronym / sponsor ID
- 2015/388(REK)
- Conditions
- Complicated Grief
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Aug 2015 (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.
A considerable proportion of bereaved individuals experience chronic and disabling grief (so-called complicated or prolonged grief). Complicated grief is associated with severe mental and physical health problems as well as impaired social and occupational functioning. Interventions based on cognitive-behavioral therapy and applied via the internet have shown to be efficacious for this condition, but have not yet been adapted and evaluated in Norway. The aim of the current study is to adapt an internet-based cognitive-behavioral intervention for complicated grief and evaluate its effectiveness as a pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Internet-based cognitive-behavioral therapyInternet-based cognitive-behavioral therapy for complicated grief |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complicated grief
- Internet access
- Fluent in Norwegian
- No concomitant psychological treatment
Key exclusion criteria (4 listed)
- Severe depression
- Psychotic symptoms
- Dissociation
- Suicidality
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 |
|---|---|---|
| Internet-based cognitive-behavioral therapyThe intervention consists of ten writing assignments | Other | Intervention group |
Primary outcome
Change from pretest to posttest in symptoms of complicated grief
Time frame: 6 weeks
Change from pretest to follow-up (1) in symptoms of complicated grief
Time frame: 18 weeks
Change from pretest to follow-up (2) in symptoms of complicated grief
Time frame: 30 weeks
9 secondary outcomes
Change from pretest to posttest in posttraumatic growth
Time frame: 6 weeks
Change from pretest to follow-up (1) in posttraumatic growth
Time frame: 18 weeks
Change from pretest to follow-up (2) in posttraumatic growth
Time frame: 30 weeks
Change from pretest to posttest in quality of life
Time frame: 6 weeks
Change from pretest to follow-up (1) in quality of life
Time frame: 18 weeks
Change from pretest to follow-up (2) in quality of life
Time frame: 30 weeks
Change from pretest to posttest in depression
Time frame: 6 weeks
Change from pretest to follow-up (1) in depression
Time frame: 18 weeks
Change from pretest to follow-up (2) in depression
Time frame: 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
Related trials for Complicated Grief
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Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder
Prolonged Grief Disorder, Complicated Grief
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Sleep Difficulties After Loss: Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
Insomnia, Insomnia Chronic
Active, not recruitingObservational study
The Aarhus Bereavement Study
Grief
Active, not recruiting
Alba - a Mobile App to Provide Bereavement Support for Adolescents in Grief
Complicated Grief Disorder
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.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive-behavioral therapy in people with Complicated Grief, run by University of Tromso.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens C. Thimm, PhD (90021044, jens.thimm@uit.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pretest to posttest in symptoms of complicated grief (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 11 Aug 2015.