A Phase 1 interventional study of Internet-Based Self-Management for Prolonged Grief Symptoms in Grief and Mental Health, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by Boston University · Phase 1, Interventional, and Prevention
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.
Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group begins treatment 6 weeks after recruitment and baseline.
Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms
This group begins treatment after enrollment and assessment with no wait period.
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.
Prolonged grief symptoms and other comorbid mental health difficulties
Time frame: Measured at Weeks pre-, post-, 6-week, 3-month
Social functioning and coping styles
Time frame: Measured at pre-, post-, 6-week, 3-month
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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