Accelerated Resolution Therapy for Complicated Grief

Accelerated Resolution Therapy for Treatment of Complicated Grief in Senior Adults

This study will examine whether accelerated resolution therapy (ART) is effective for the treatment of prolonged and complicated grief and associated psychological trauma among older adult hospice caregivers who have experienced the death of an immediate family member at least 12 months ago.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms; Grief; Trauma, Psychological
• Intervention / Treatment: Behavioral: Accelerated Resolution Therapy

Detailed Description

ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers. Mental health professionals are delivering ART in clinical practice to assist with grief; however, there is a need for formal research evaluation of the effects of ART on complicated grief and psychological distress.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Harleah Buck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult age 60 years of age or older
• previous primary caregiver of immediate family member who died after enrollment in hospice with the death occurring at least 12 months prior to enrollment
• current symptoms indicative of proposed diagnostic criteria for complicated grief disorder, as proposed by Shear et al. (2011)
• current score of >25 on the 19-item Inventory of Complicated Grief
• current symptoms indicative of significant psychological trauma, as documented by score >33on the 20-item DSM-5 PTSD checklist (PCL-5)26 or score >4 on the PDSQ PTSD subscale
• denial of suicidal ideation or intent, with no evidence of psychotic behavior

Exclusion Criteria:

• engaged in another psychotherapy regimen that could also influence symptoms of PCG - - major psychiatric disorder (e.g. bipolar disorder) deemed likely to interfere with treatment delivery
• current substance abuse dependence (alcohol and/or drug) treatment anticipated to interfere with treatment delivery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Accelerated Resolution Therapy; ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers
Active Comparator: Wait list controlled	Behavioral: Accelerated Resolution Therapy; ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in complicated grief symptoms	Response on the 19-item Inventory of Complicated Grief (ICF) over the course of the 4-week intervention period. Scores range from 0-76 with a score >24 indicating presence of complicated grief.	4 weeks, follow up at 12 weeks
change in psychological trauma	The PCL-5 (PTSD Patient Checklist)26 is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma)(corresponding to criteria B-E). The total symptom severity score ranges from 0 to . A diagnostic cut-point for PTSD of 33 has been recommended. In addition, it is generally accepted that a reduction of 10 points or more on the PCL-5 is indicative of statistical and clinically meaningful improvement.	4 weeks, follow up at 12 weeks
change in depressive symptoms	The Center for Epidemiologic Studies Depression Scale(CES-D)37is a widely used 20-item scale that has proven useful both as a screening instrument to detect individuals at risk for depression, and to measure the symptoms of depression.	4 weeks, follow up at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in stress response	For the biomarkers of sAA and IL-6, measurement will occur using the protocols listed in the Salimetrics® α-Amylase Kinetic Enzyme Assay Kit for kinetic measurement of sAA activity (Appendix B) and Salimetrics® Salivary Interleukin-6 Elisa Kit KIT (Appendix C). The unstimulated passive drool method will be used. Participants will be asked to tilt head forward, allowing the saliva to pool on the floor of the mouth, and then pass the saliva through the SalivaBio Collection Aid (SCA) into a polypropylene vial.	weekly pre to post ART and over the 4 week intervention period

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Harleah Buck, PhD, University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Psychological Trauma
• Other Study ID Numbers: 1R21AG056584-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No