Clinical trial NCT01556048: Pilot Study of Behavioral Activation for Prolonged Grief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Complicated Grief
Prolonged Grief Disorder
Major Depressive Disorder
Posttraumatic Stress Disorder
Keywords: Behavior therapy
Bereavement
Complicated grief
Depression
Posttraumatic Stress Disorder
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization
timeFrame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
measure: Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization
timeFrame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
measure: Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization
timeFrame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Secondary outcomes:
measure: Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization
timeFrame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
measure: Therapy credibility and client expectancy for improvement after treatment
timeFrame: Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Antony Papa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: