Pilot Study of Behavioral Activation for Prolonged Grief

Phase 1

Completed

• Conditions: Major Depressive Disorder; Posttraumatic Stress Disorder; Complicated Grief; Prolonged Grief Disorder
• Interventions: Behavioral: Behavioral Activation

• Registration Number: NCT01556048
• Lead Sponsor: Anthony Papa

Brief Summary

The Institute of Medicine identifies Prolonged Grief (PG) as a critical under-addressed public health problem for which are no empirically supported treatments. The purpose of this application is to pilot-test Behavioral Activation (BA) therapy for PG. BA is a well supported, stand alone intervention for depression and recently applied to posttraumatic stress disorder, which reduces rumination and avoidance behaviors that otherwise thwart access to natural rewarding contingencies and resources. The treatment focuses on promoting stable, active routines, self-care behaviors, enhanced self-efficacy, and reengagement with pleasurable activities and significant social resources. Rumination, disengagement, and low self-efficacy are defining features of PG. Further, in response to loss of intimates, the key factors that differentiate resilient people from those that have difficulties adapting is the maintenance or fast resumption of social and occupational functioning. Thus, the main hypothesis of this study is that BA for PG will result in clinically significant reductions in rumination and functional disengagement. This is a preliminary small-scale pilot assessment of potential efficacy and feasibility of completing a large scale study of BA for PG.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-16
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• meet criteria for Prolonged Grief Disorder
• must be 21 years old or older
• if taking psychotropic medication, must have been on a stable dose for three or more months prior to study entry

Exclusion Criteria

• presence of active suicidal or homicidal ideation
• a history of psychotic symptoms
• current participation in psychosocial treatment focused on grief symptoms
• active substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMMEDIATE START GROUP	Behavioral Activation	Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study
DELAY START GROUP	Behavioral Activation	Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study

Primary Outcome Measures

Name	Time	Method
Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	Inventory of Complicated Grief-Revised
Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	PTSD Checklist-Specific
Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	Depression Anxiety Stress Scales

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	Ruminative Response Scale
Therapy credibility and client expectancy for improvement after treatment	Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)	Credibility/ Expectancy Questionnaire

Trial Locations

Locations (1)

University of Nevada, Reno; 🇺🇸 Reno, Nevada, United States