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Pilot Study of Behavioral Activation for Prolonged Grief

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01556048
Enrollment
25
Registered
2012-03-16
Start date
2009-02-28
Completion date
2012-05-31
Last updated
2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Behavior therapy, Bereavement, Complicated grief, Depression, Posttraumatic Stress Disorder

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.

Interventions

BEHAVIORALBehavioral 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

Sponsors

Anthony Papa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomizationAssessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomizationInventory of Complicated Grief-Revised
Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomizationAssessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomizationPTSD Checklist-Specific
Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomizationAssessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomizationDepression Anxiety Stress Scales

Secondary

MeasureTime frameDescription
Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomizationAssessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomizationRuminative Response Scale
Therapy credibility and client expectancy for improvement after treatmentAssessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)Credibility/ Expectancy Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026