Accelerated Resolution Therapy for Complicated Grief

Depressive Symptoms Clinical Trial

Official title:

Accelerated Resolution Therapy for Treatment of Complicated Grief in Senior Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484338
• Other study ID #: 1R21AG056584-01
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2020
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Grief
• Psychological Trauma
• Trauma, Psychological

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

Locations

Country	Name	City	State
United States	Harleah Buck	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	change in stress response	For the biomarkers of sAA and IL-6, measurement will occur using the protocols listed in the Salimetrics® a-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