Pilot Study of Behavioral Activation for Prolonged Grief

NCT ID: NCT01556048

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-05-31

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.

Conditions

Complicated Grief; Prolonged Grief Disorder; Major Depressive Disorder; Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMMEDIATE START GROUP

Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

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

DELAY START GROUP

Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study

Group Type: PLACEBO_COMPARATOR

Behavioral Activation

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anthony Papa

OTHER

Sponsor Role: lead

Responsible Party

Anthony Papa

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antony Papa, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Reno

Locations

University of Nevada, Reno

Reno, Nevada, United States

Countries

United States

Other Identifiers

SA08/09-07

Identifier Type: -

Identifier Source: org_study_id