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

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ClinicalTrials.gov Identifier: NCT00598884
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University

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.

Condition or disease Intervention/treatment Phase
Grief Mental Health Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms Phase 1

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.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Internet-Based Self-Management Intervention for Prolonged Grief
Study Start Date : August 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 6-week delay start
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.
Experimental: No delay start
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.



Primary Outcome Measures :
  1. Prolonged grief symptoms and other comorbid mental health difficulties [ Time Frame: Measured at Weeks pre-, post-, 6-week, 3-month ]

Secondary Outcome Measures :
  1. Social functioning and coping styles [ Time Frame: Measured at pre-, post-, 6-week, 3-month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598884


Locations
United States, Massachusetts
Boston VA Medical Center
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Brett T. Litz, PhD Boston University

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00598884     History of Changes
Other Study ID Numbers: R34MH079884 ( U.S. NIH Grant/Contract )
R34MH079884 ( U.S. NIH Grant/Contract )
DSIR 83-ATP
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013

Keywords provided by Boston University:
Clinical Protocols
Behavioral Research
Prevention