Pilot Study of Behavioral Activation for Prolonged Grief

Major Depressive Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556048
• Other study ID #: SA08/09-07
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2012
• Last updated: December 1, 2014
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2014
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board: Office of Human Research Protection, University of Nevada Reno
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complicated Grief
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Posttraumatic Stress Disorder
• Prolonged Grief Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	University of Nevada, Reno	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Anthony Papa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in grief symptoms at weeks 12, 24, and 36 post randomization	Inventory of Complicated Grief-Revised	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	No
Primary	Change from Baseline in PTSD symptoms at weeks 12, 24, and 36 post randomization	PTSD Checklist-Specific	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	No
Primary	Change from Baseline in symptoms of Major Depressive Disorder at Weeks 12, 24, and 36 post randomization	Depression Anxiety Stress Scales	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	No
Secondary	Change from Baseline in levels of rumination at Weeks 12, 24, and 36 post randomization	Ruminative Response Scale	Assessments occurring in Weeks 1 (Baseline), 12, 24, and 36 post randomization	No
Secondary	Therapy credibility and client expectancy for improvement after treatment	Credibility/ Expectancy Questionnaire	Assessments occurring post-treatment (12 weeks for immediate start group, 24 weeks for delay start group)	No