Pilot Study of Behavioral Activation for Prolonged Grief

NCT01556048 | Completed Phase 1

• 1 other identifier: SA08/09-07
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

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

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

• Therapy credibility and client expectancy for improvement after treatment

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

Study Arms (2)

IMMEDIATE START GROUP

EXPERIMENTAL

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

Behavioral: Behavioral Activation

DELAY START GROUP

PLACEBO COMPARATOR

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

Behavioral: Behavioral Activation

Interventions

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

DELAY START GROUP; IMMEDIATE START GROUP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• presence of active suicidal or homicidal ideation
• a history of psychotic symptoms
• current participation in psychosocial treatment focused on grief symptoms
• active substance abuse

Sponsors & Collaborators

• Anthony Papa: lead

Study Sites (1)

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

MeSH Terms

Conditions

Prolonged Grief Disorder; Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Stress Disorders, Traumatic; Behavioral Symptoms; Behavior

Study Officials

• Antony Papa, Ph.D.

  University of Nevada, Reno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 16, 2012
• Study Start: February 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)