Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03484338
Other study ID # 1R21AG056584-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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 SalimetricsĀ® a-Amylase Kinetic Enzyme Assay Kit for kinetic measurement of sAA activity (Appendix B) and SalimetricsĀ® 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
See also
  Status Clinical Trial Phase
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05702086 - Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT06100146 - Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls N/A
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT04403126 - To Increase Psychological Well-being by the Implementation of Forgiveness Education N/A
Recruiting NCT05078424 - Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong N/A
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Recruiting NCT04082052 - Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike N/A
Completed NCT04011540 - Digital Data in Mental Health Therapy N/A
Not yet recruiting NCT06413849 - Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers N/A
Not yet recruiting NCT03659591 - Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost N/A
Not yet recruiting NCT02133170 - "Mindfulness vs Psychoeducation in Bipolar Disorder" N/A
Completed NCT02314390 - Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial N/A
Completed NCT01628016 - The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms N/A