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Pilot Study of Behavioral Activation for Prolonged Grief

Primary Purpose

Complicated Grief, Prolonged Grief Disorder, Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Sponsored by
Anthony Papa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Grief focused on measuring Behavior therapy, Bereavement, Complicated grief, Depression, Posttraumatic Stress Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nevada, Reno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMMEDIATE START GROUP

DELAY START GROUP

Arm Description

Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study

Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study

Outcomes

Primary Outcome Measures

Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization
Inventory of Complicated Grief-Revised
Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization
PTSD Checklist-Specific
Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization
Depression Anxiety Stress Scales

Secondary Outcome Measures

Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization
Ruminative Response Scale
Therapy credibility and client expectancy for improvement after treatment
Credibility/ Expectancy Questionnaire

Full Information

First Posted
March 12, 2012
Last Updated
December 1, 2014
Sponsor
Anthony Papa
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1. Study Identification

Unique Protocol Identification Number
NCT01556048
Brief Title
Pilot Study of Behavioral Activation for Prolonged Grief
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anthony Papa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Grief, Prolonged Grief Disorder, Major Depressive Disorder, Posttraumatic Stress Disorder
Keywords
Behavior therapy, Bereavement, Complicated grief, Depression, Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMMEDIATE START GROUP
Arm Type
Experimental
Arm Description
Randomized to participate in Behavioral Activation for pathological grief starting at Week 1 of entry into the study
Arm Title
DELAY START GROUP
Arm Type
Placebo Comparator
Arm Description
Randomized to participate in Behavioral Activation for pathological grief starting at Week 12 of entry into the study
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization
Description
Inventory of Complicated Grief-Revised
Time Frame
Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Title
Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization
Description
PTSD Checklist-Specific
Time Frame
Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Title
Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization
Description
Depression Anxiety Stress Scales
Time Frame
Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Secondary Outcome Measure Information:
Title
Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization
Description
Ruminative Response Scale
Time Frame
Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization
Title
Therapy credibility and client expectancy for improvement after treatment
Description
Credibility/ Expectancy Questionnaire
Time Frame
Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antony Papa, Ph.D.
Organizational Affiliation
University of Nevada, Reno
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States

12. IPD Sharing Statement

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Pilot Study of Behavioral Activation for Prolonged Grief

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