Internet-based Intervention for Complicated Grief: A Pilot Study

Complicated Grief Clinical Trial

Official title:

Internet-based Intervention for Complicated Grief: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02519569
• Other study ID #: 2015/388(REK)
• Status: Not yet recruiting
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 6, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: University of Tromso
• Contact: Jens C. Thimm, PhD
• Phone: 90021044
• Email: jens.thimm[@]uit.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Complicated grief

• Internet access

• Fluent in Norwegian

• No concomitant psychological treatment

Exclusion Criteria:

• Severe depression

• Psychotic symptoms

• Dissociation

• Suicidality

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complicated Grief

Intervention

Other:
• Internet-based cognitive-behavioral therapy
The intervention consists of ten writing assignments

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from pretest to posttest in symptoms of complicated grief		6 weeks	No
Primary	Change from pretest to follow-up (1) in symptoms of complicated grief		18 weeks	No
Primary	Change from pretest to follow-up (2) in symptoms of complicated grief		30 weeks	No
Secondary	Change from pretest to posttest in posttraumatic growth		6 weeks	No
Secondary	Change from pretest to follow-up (1) in posttraumatic growth		18 weeks	No
Secondary	Change from pretest to follow-up (2) in posttraumatic growth		30 weeks	No
Secondary	Change from pretest to posttest in quality of life		6 weeks	No
Secondary	Change from pretest to follow-up (1) in quality of life		18 weeks	No
Secondary	Change from pretest to follow-up (2) in quality of life		30 weeks	No
Secondary	Change from pretest to posttest in depression		6 weeks	No
Secondary	Change from pretest to follow-up (1) in depression		18 weeks	No
Secondary	Change from pretest to follow-up (2) in depression		30 weeks	No