CClinicalTrials.gg
CompletedNCT00598884Updated Jun 24, 2013

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Grief
  • Mental Health

Keywords

  • Clinical Protocols
  • Behavioral Research
  • Prevention
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
135 participants (actual)

Study arms

  • Experimental
    6-week delay start

    This group begins treatment 6 weeks after recruitment and baseline.

    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.

    Behavioral: Internet-Based Self-Management for Prolonged Grief Symptoms

Interventions

  • BehavioralInternet-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.

06

What researchers measure

Primary outcomes

  1. Prolonged grief symptoms and other comorbid mental health difficulties

    Time frame: Measured at Weeks pre-, post-, 6-week, 3-month

Secondary outcomes

  1. Social functioning and coping styles

    Time frame: Measured at pre-, post-, 6-week, 3-month

07

Study locations

1 site
  • Boston VA Medical Center
    Boston, Massachusetts 02130, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00598884
Lead sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jan 23, 2008
Start date
Aug 2009
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Jun 24, 2013

Study contacts

Brett T. Litz, PhD
principal investigator · Boston University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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