Pilot Study of Behavioral Activation for Prolonged Grief

Anthony Papa

Status and phase: Completed; Phase 1

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

Treatments: Behavioral: Behavioral Activation

Study type: Interventional

Funder types: Other

Identifiers

NCT01556048

SA08/09-07

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

IMMEDIATE START GROUP

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral Activation

DELAY START GROUP

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Behavioral Activation