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Completed

NCT Number: NCT01556048

Pilot Study of Behavioral Activation for Prolonged Grief

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation

Behavioral

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

Primary outcomes

  1. Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization

    Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization

    Inventory of Complicated Grief-Revised

  2. Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization

    Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization

    PTSD Checklist-Specific

  3. Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization

    Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization

    Depression Anxiety Stress Scales

Secondary outcomes

  1. Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization

    Time frame: Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization

    Ruminative Response Scale

  2. Therapy credibility and client expectancy for improvement after treatment

    Time frame: Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)

    Credibility/ Expectancy Questionnaire

Sponsors and collaborators

Lead sponsor

Anthony Papa

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2012
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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