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

NCT00598884 | Completed Phase 1 DMC

• 2 other identifiers: R34MH079884DSIR 83-ATP
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Grief; Mental Health

Keywords

Clinical Protocols; Behavioral Research; Prevention

Outcome Measures

Primary Outcomes (1)

• Prolonged grief symptoms and other comorbid mental health difficulties

  Measured at Weeks pre-, post-, 6-week, 3-month

Secondary Outcomes (1)

• Social functioning and coping styles

  Measured at pre-, post-, 6-week, 3-month

Study Arms (2)

6-week delay start

EXPERIMENTAL

This group begins treatment 6 weeks after recruitment and baseline.

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

No delay start

EXPERIMENTAL

This group begins treatment after enrollment and assessment with no wait period.

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

Interventions

Internet-Based Self-Management for Prolonged Grief Symptoms BEHAVIORAL

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.

6-week delay start; No delay start

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston VA Medical Center

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Brett T. Litz, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: August 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (1)