Pilot Study of Behavioral Activation for Prolonged Grief

Study Overview
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Brief Summary
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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
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Complicated Grief, Prolonged Grief Disorder, Major Depressive Disorder, Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Behavioral Activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMMEDIATE START GROUP<br>Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study | Behavioral: Behavioral Activation<br>* 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<br>|
| Placebo Comparator: DELAY START GROUP<br>Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study | Behavioral: Behavioral Activation<br>* 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<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior therapy, Bereavement, Complicated grief, Depression, Posttraumatic Stress Disorder