Internet-based Intervention for Complicated Grief: A Pilot Study

August 6, 2015 updated by: Jens Thimm, University of Tromso
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe depression
  • Psychotic symptoms
  • Dissociation
  • Suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from pretest to posttest in symptoms of complicated grief
Time Frame: 6 weeks
6 weeks
Change from pretest to follow-up (1) in symptoms of complicated grief
Time Frame: 18 weeks
18 weeks
Change from pretest to follow-up (2) in symptoms of complicated grief
Time Frame: 30 weeks
30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from pretest to posttest in posttraumatic growth
Time Frame: 6 weeks
6 weeks
Change from pretest to follow-up (1) in posttraumatic growth
Time Frame: 18 weeks
18 weeks
Change from pretest to follow-up (2) in posttraumatic growth
Time Frame: 30 weeks
30 weeks
Change from pretest to posttest in quality of life
Time Frame: 6 weeks
6 weeks
Change from pretest to follow-up (1) in quality of life
Time Frame: 18 weeks
18 weeks
Change from pretest to follow-up (2) in quality of life
Time Frame: 30 weeks
30 weeks
Change from pretest to posttest in depression
Time Frame: 6 weeks
6 weeks
Change from pretest to follow-up (1) in depression
Time Frame: 18 weeks
18 weeks
Change from pretest to follow-up (2) in depression
Time Frame: 30 weeks
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tromso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/388(REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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