Accelerated Resolution Therapy for Complicated Grief

Not Applicable

Completed

• Conditions: Depressive Symptoms; Grief; Trauma, Psychological
• Interventions: Behavioral: Accelerated Resolution Therapy

• Registration Number: NCT03484338
• Lead Sponsor: University of South Florida

Brief Summary

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.

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 Timeline

• Study Start: 2018-02-20
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Primary Completion: 2019-07-31
• Study Completion: 2019-10-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Accelerated Resolution Therapy	-
Wait list controlled	Accelerated Resolution Therapy	-

Primary Outcome Measures

Name	Time	Method
change in complicated grief symptoms	4 weeks, follow up at 12 weeks	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.
change in psychological trauma	4 weeks, follow up at 12 weeks	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.
change in depressive symptoms	4 weeks, follow up at 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
change in stress response	weekly pre to post ART and over the 4 week intervention period	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.

Trial Locations

Locations (1)

Harleah Buck; 🇺🇸 Tampa, Florida, United States