Pilot Study of Behavioral Activation for Prolonged Grief

Sponsor

Anthony Papa (Other)

Overall Status

Completed

CT.gov ID

NCT01556048

Collaborator

(none)

Enrollment

Location

Arms

38.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complicated Grief Prolonged Grief Disorder Major Depressive Disorder Posttraumatic Stress Disorder	Behavioral: Behavioral Activation	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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