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Effectiveness of an Internet-Based Self-Management Program in Treating Prolonged Grief Disorder
This study is not yet open for participant recruitment.
Verified by National Institute of Mental Health (NIMH), August 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00598884
  Purpose

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.


Condition Intervention Phase
Grief
Mental Health
Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms
Phase I

MedlinePlus related topics: Mental Health
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment
Official Title: Internet-Based Self-Management Intervention for Prolonged Grief

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Prolonged grief symptoms and other comorbid mental health difficulties [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social functioning and coping styles [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 185
Study Start Date: August 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
6-week delay start: Experimental
This group begins treatment 6 weeks after recruitment and baseline.
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.
12-week delay start: Experimental
This group begins treatment 12 weeks after recruitment and baseline.
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.
No delay start: Experimental
This group begins treatment immediately after recruitment and baseline.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598884

Contacts
Contact: Brett T. Litz, PhD 857-364-4131 brett.litz@va.gov

Locations
United States, Massachusetts
Boston VA Medical Center
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: Brett T. Litz, PhD Boston University
  More Information

Responsible Party: Boston University School of Medicine, Department of Psychiatry ( Brett T. Litz/Professor )
Study ID Numbers: R34 MH079884, DSIR 83-ATP
Study First Received: January 11, 2008
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00598884  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Clinical Protocols
Behavioral Research
Prevention

ClinicalTrials.gov processed this record on January 14, 2009