Effectiveness of an Internet-Based Self-Management Program in Treating Prolonged Grief Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00598884
First received: January 11, 2008
Last updated: March 17, 2009
Last verified: March 2009

January 11, 2008
March 17, 2009
August 2009
November 2010   (final data collection date for primary outcome measure)
Prolonged grief symptoms and other comorbid mental health difficulties [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00598884 on ClinicalTrials.gov Archive Site
Social functioning and coping styles [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of an Internet-Based Self-Management Program in Treating Prolonged Grief Disorder
Internet-Based Self-Management Intervention for Prolonged Grief

This study will evaluate the effectiveness of an Internet-based self-help program in treating people who are at risk for developing prolonged grief disorder following a recent loss.

Prolonged grief disorder (PGD) is a severe psychiatric condition that occurs in about 10% of people who experience a recent loss. PGD does not just go away with time and is associated with considerable functional impairment, physical and mental health problems, lost productivity, lack of interest in previously enjoyed activities, suicide, and depression. Because the majority of people with PGD are elderly and less capable of pursuing outside care, making readily available treatments for PGD is very important. Current treatments for PGD include psychotherapy and antidepressant medications, but there is very little solid research on the effectiveness of these treatments. Previous studies have shown that Internet-based mental health treatments are an effective and cost-efficient way to provide self-help to people who otherwise would not seek care. Using strategies from the psychotherapy known as cognitive behavioral therapy (CBT), this study will evaluate the effectiveness of an Internet-based self-help program in treating people who are at risk for developing prolonged grief disorder following a recent loss.

Participation in this study will last 6 weeks. Participants will be asked to log-on to the study's self-help Web site three times per week for the 6 weeks of treatment. During these 30-minute Internet sessions, participants will read or listen to information about grief and coping with grief and will complete computer exercises that involve identifying self-care needs, support systems, and short-term goals. Participants will also be asked to perform off-line activities that are designed to increase self-care and social activities and that may take anywhere from a few minutes to 30 minutes per day. Participants will be randomly assigned to begin the treatment program 12, 18, or 24 weeks after their loss. For all participants, there will be four assessments, occurring 12, 18, 24, and 30 weeks after the loss, regardless of when the participants start the program. These assessments will include questions about mental and physical health adjustment, beliefs about the loss, and coping status.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Grief
  • Mental Health
Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms
The treatment consists of empirically derived cognitive behavioral therapy strategies to promote stable and active routines, self-care, accommodation of loss, enhanced self-efficacy, re-engagement in pleasurable activities, and reattachment with significant others. Treatment sessions will be Internet-based and will occur three times per week for 6 weeks.
  • Experimental: 6-week delay start
    This group begins treatment 6 weeks after recruitment and baseline.
    Intervention: Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms
  • Experimental: 12-week delay start
    This group begins treatment 12 weeks after recruitment and baseline.
    Intervention: Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms
  • Experimental: No delay start
    This group begins treatment immediately after recruitment and baseline.
    Intervention: Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
185
December 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Meets criteria for a diagnosis of prolonged grief (with the exception of the requirement for 6-month duration of symptoms) using the Prolonged Grief -13
  • Access to the Internet

Exclusion Criteria:

  • Lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders
  • History of substance or alcohol dependence other than nicotine in the year prior to study entry
  • Significant suicidal ideation
  • Concurrent psychotherapy initiated within 3 months prior to study entry, or ongoing psychotherapy specifically targeting loss; general supportive therapy initiated more than 3 months prior to study entry is acceptable
Both
21 Years and older
No
Contact: Brett T. Litz, PhD 857-364-4131 brett.litz@va.gov
United States
 
NCT00598884
R34 MH079884, DSIR 83-ATP
Yes
Brett T. Litz/Professor, Boston University School of Medicine, Department of Psychiatry
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Brett T. Litz, PhD Boston University
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP