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Pilot Study of Behavioral Activation for Prolonged Grief

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Nevada, Las Vegas.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Anthony Papa, University of Nevada
ClinicalTrials.gov Identifier:
NCT01556048
First received: March 12, 2012
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Complicated Grief
Prolonged Grief Disorder
Major Depressive Disorder
Posttraumatic Stress Disorder
Behavioral: Behavioral Activation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Inventory of Complicated Grief-Revised

  • 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 ] [ Designated as safety issue: No ]
    PTSD Checklist-Specific

  • 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 ] [ Designated as safety issue: No ]
    Depression Anxiety Stress Scales


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Ruminative Response Scale

  • 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) ] [ Designated as safety issue: No ]
    Credibility/ Expectancy Questionnaire


Enrollment: 25
Study Start Date: February 2009
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556048

Locations
United States, Nevada
University of Nevada, Reno
Reno, Nevada, United States, 89557
Sponsors and Collaborators
Anthony Papa
Investigators
Principal Investigator: Antony Papa, Ph.D. University of Nevada, Reno
  More Information

No publications provided

Responsible Party: Anthony Papa, Assistant Professor, University of Nevada
ClinicalTrials.gov Identifier: NCT01556048     History of Changes
Other Study ID Numbers: SA08/09-07
Study First Received: March 12, 2012
Last Updated: April 13, 2012
Health Authority: Institutional Review Board: Office of Human Research Protection, University of Nevada Reno

Keywords provided by University of Nevada, Las Vegas:
Behavior therapy
Bereavement
Complicated grief
Depression
Posttraumatic Stress Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014