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Internet-based Intervention for Complicated Grief: A Pilot Study

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ClinicalTrials.gov Identifier: NCT02519569
Recruitment Status : Unknown
Verified August 2015 by Jens Thimm, University of Tromso.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Jens Thimm, University of Tromso

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Complicated Grief Other: Internet-based cognitive-behavioral therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Intervention for Complicated Grief: A Pilot Study
Study Start Date : August 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Arm Intervention/treatment
Experimental: Intervention group
Internet-based cognitive-behavioral therapy for complicated grief
Other: Internet-based cognitive-behavioral therapy
The intervention consists of ten writing assignments




Primary Outcome Measures :
  1. Change from pretest to posttest in symptoms of complicated grief [ Time Frame: 6 weeks ]
  2. Change from pretest to follow-up (1) in symptoms of complicated grief [ Time Frame: 18 weeks ]
  3. Change from pretest to follow-up (2) in symptoms of complicated grief [ Time Frame: 30 weeks ]

Secondary Outcome Measures :
  1. Change from pretest to posttest in posttraumatic growth [ Time Frame: 6 weeks ]
  2. Change from pretest to follow-up (1) in posttraumatic growth [ Time Frame: 18 weeks ]
  3. Change from pretest to follow-up (2) in posttraumatic growth [ Time Frame: 30 weeks ]
  4. Change from pretest to posttest in quality of life [ Time Frame: 6 weeks ]
  5. Change from pretest to follow-up (1) in quality of life [ Time Frame: 18 weeks ]
  6. Change from pretest to follow-up (2) in quality of life [ Time Frame: 30 weeks ]
  7. Change from pretest to posttest in depression [ Time Frame: 6 weeks ]
  8. Change from pretest to follow-up (1) in depression [ Time Frame: 18 weeks ]
  9. Change from pretest to follow-up (2) in depression [ Time Frame: 30 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complicated grief
  • Internet access
  • Fluent in Norwegian
  • No concomitant psychological treatment

Exclusion Criteria:

  • Severe depression
  • Psychotic symptoms
  • Dissociation
  • Suicidality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519569


Contacts
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Contact: Jens C. Thimm, PhD 90021044 jens.thimm@uit.no

Sponsors and Collaborators
University of Tromso
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Responsible Party: Jens Thimm, Associate professor, University of Tromso
ClinicalTrials.gov Identifier: NCT02519569    
Other Study ID Numbers: 2015/388(REK)
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015