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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598884
First Posted: January 23, 2008
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University
January 11, 2008
January 23, 2008
June 24, 2013
August 2009
November 2012   (Final data collection date for primary outcome measure)
Prolonged grief symptoms and other comorbid mental health difficulties [ Time Frame: Measured at Weeks pre-, post-, 6-week, 3-month ]
Prolonged grief symptoms and other comorbid mental health difficulties [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ]
Complete list of historical versions of study NCT00598884 on ClinicalTrials.gov Archive Site
Social functioning and coping styles [ Time Frame: Measured at pre-, post-, 6-week, 3-month ]
Social functioning and coping styles [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ]
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.

This is a randomized, wait-list control design. Participants will be randomized to immediately begin the intervention or to wait for 6-weeks before beginning. The intervention will ask participants to log-on to the study's self-help website three times per week for the 6 weeks of treatment. During these sessions, participants will be offered optional information about grief and coping with grief and will be required to complete computer exercises that involve identifying self-care needs, support systems, and short- and long-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. For all participants, there will be four assessments, after randomization, before beginning treatment (these 2 are the same for the immediate group), upon completion of the intervention, at 6 weeks post-intervention, at 3 months post-intervention (for immediate group). 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: None (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: No delay start
    This group begins treatment after enrollment and assessment with no wait period.
    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.
 
Completed
135
November 2012
November 2012   (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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00598884
R34MH079884( U.S. NIH Grant/Contract )
R34MH079884 ( U.S. NIH Grant/Contract )
DSIR 83-ATP
Yes
Not Provided
Not Provided
Boston University
Boston University
National Institute of Mental Health (NIMH)
Principal Investigator: Brett T. Litz, PhD Boston University
Boston University
June 2013

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