Pilot Study of Behavioral Activation for Prolonged Grief

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Posttraumatic Stress Disorder; Prolonged Grief Disorder; Complicated Grief
• Intervention / Treatment: Behavioral: Behavioral Activation

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89557
      • University of Nevada, Reno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMMEDIATE START GROUP; Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study	Behavioral: Behavioral Activation; Behavioral Activation for Major Depressive Disorder (BA; Martell, Addis, & Jacobson, 2001) is based on behavioral theories of depression, which posit that psychopathology occurs when active, goal-directed behavioral repertoires have been either unreinforced or punished. These aversive consequences tend to reinforce escape and avoidance behavior, such as passively ruminating on unmet needs and/or deprivations, rather than actively engaging the environment. BA employs operant conditioning principles to increase active, goal-directed behavioral strategies and decrease passive or avoidant behavioral strategies to help people engage with and obtain adequate reinforcement from their environment. Use of BA was based research suggesting that disengagement/avoidance is related to prolonged pathology after loss
Placebo Comparator: DELAY START GROUP; Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study	Behavioral: Behavioral Activation; Behavioral Activation for Major Depressive Disorder (BA; Martell, Addis, & Jacobson, 2001) is based on behavioral theories of depression, which posit that psychopathology occurs when active, goal-directed behavioral repertoires have been either unreinforced or punished. These aversive consequences tend to reinforce escape and avoidance behavior, such as passively ruminating on unmet needs and/or deprivations, rather than actively engaging the environment. BA employs operant conditioning principles to increase active, goal-directed behavioral strategies and decrease passive or avoidant behavioral strategies to help people engage with and obtain adequate reinforcement from their environment. Use of BA was based research suggesting that disengagement/avoidance is related to prolonged pathology after loss

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anthony Papa
• Investigators: Principal Investigator: Antony Papa, Ph.D., University of Nevada, Reno

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 16, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Posttraumatic Stress Disorder; Bereavement; Behavior therapy; Complicated grief
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Trauma and Stressor Related Disorders; Depressive Disorder; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depressive Disorder, Major
• Other Study ID Numbers: SA08/09-07