Effectiveness of an Internet-Based Self-Management Program in Treating Prolonged Grief Disorder
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | January 11, 2008 | ||||
| Last Updated Date | March 17, 2009 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prolonged grief symptoms and other comorbid mental health difficulties [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00598884 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Social functioning and coping styles [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of an Internet-Based Self-Management Program in Treating Prolonged Grief Disorder | ||||
| Official Title ICMJE | Internet-Based Self-Management Intervention for Prolonged Grief | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 185 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00598884 | ||||
| Other Study ID Numbers ICMJE | R34 MH079884, DSIR 83-ATP | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Brett T. Litz/Professor, Boston University School of Medicine, Department of Psychiatry | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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