Shortened Prolonged Exposure Therapy for Chronic PTSD in Taiwanese Adults

Shortened Prolonged Exposure Therapy for Chronic PTSD: A Systematic Case Study

The present study aimed to investigate the efficacy of 60-minute sessions of prolonged exposure (PE) for patients with posttraumatic stress disorder (PTSD) in Taiwan. A systematic case study will be employed to compare the efficacy of 60-minute PE session versus standard 90-minute session with eight Taiwanese PTSD patients. Participants will include the individuals aged 18 or older who meet a diagnosis of DSM-5 PTSD and to experience moderate to severe symptoms for at least 3 months. Those who have current substance dependence, psychosis, and acute suicidality (i.e., recent suicidal ideation with intent and plan) will be excluded. Participants will receive 10-15 weekly session of PE treatment with 60- or 90-minute sessions. The investigators hypothesized that: (a) 60-minute PE is as effective as 90-minute PE in reducing PTSD and depressive symptoms as well as in promoting posttraumatic growth (PTG); and (b) the treatment gains will be maintained at 3-month follow-up.

Study Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Prolonged Exposure Therapy

Detailed Description

Background: Posttraumatic stress disorder (PTSD) is a common psychological disorder following trauma and disaster. Due to the frequent occurrence of disasters induced by natural hazards, many Taiwanese people suffer from post-disaster mental health problems, suggesting the necessity of promoting evidence-based psychotherapies for PTSD in Taiwan. However, there has been little concern about this necessity over the past decades. To date, several evidence-based psychotherapies for PTSD have been developed, and prolonged exposure treatment (PE) has the largest number of studies supporting its efficacy and effectiveness. PE has been found effective with the widest range of trauma populations and has been studies across cultures. Given its strong evidence base, the investigators tested the efficacy and feasibility of PE for Taiwanese PTSD patients. It is noted that the original length of PE session is 90 minutes, which is difficult to get reimbursement by insurance and may prevent mental health professionals to use PE. Recent researchers shortened the length of PE session to 60 minutes and found its efficacy was non-inferior to standard 90-minute PE session (Nacasch et al., 2015; van Minnen & Foa, 2006). Accordingly, this study aims to examine the efficacy of 60-minute PE sessions versus standard 90-minute session for patients with PTSD in Taiwan.

Study Hypothesis: (a) 60-minute PE session is as effective as 90-minute PE session in reducing PTSD and depressive symptoms as well as in promoting posttraumatic growth (PTG); and (b) the treatment gains will be maintained at 3-month follow-up. A systematic case study will be employed to test the hypotheses.

Participants: Participants will include eight individuals aged 18 or older who meet a diagnosis of DSM-5 PTSD and to experience moderate to severe symptoms for at least 3 months. Those who have current substance dependence, psychosis, and acute suicidality (i.e., recent suicidal ideation with intent and plan) will be excluded.

Study Design: All enrolled participants will attend 10-15 weekly 60- or 90-minute PE sessions. Independent evaluators will assess PTSD diagnosis using the PTSD Symptoms Scale Interview for DSM-5 (PSSI-5) at pre- and post-treatment and at the three-month follow-up. Psychiatric comorbidity will be assessed using the MINI 7.0.2 at pretreatment. Participants will complete the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), Posttraumatic Cognitions Inventory (PTCI), and Posttraumatic Growth Inventory -Extended version (PTGI-X) at pre- and post-treatment and at the three-month follow-up. The PDS-5 and BDI-II will also be administered every two weeks during treatment.

Statistical Analysis: The nonparametric tests will be used given the small sample size. Wilcoxon signed-rank test will be conducted to test pre-post differences. Mann-Whitney U test will be conducted examine whether 60-minute PE session is as effective as 90-minute PE session in reducing PTSD and depressive symptoms as well as increasing PTG at post-treatment and three-month follow-up.

Expected Outcome: The investigators except that shortened PE will result in substantial improvement in PTSD and depressive symptoms in patients with PTSD in Taiwan.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Jen Su, Ph.D.; Phone Number: 3421 +886-3-2118800; Email: suyijen@mail.cgu.edu.tw

Study Locations

• Taiwan
  • Guishan Dist.
    • Taoyuan, Guishan Dist., Taiwan, 33302
      • Recruiting
      • Graduate Institute of Behavioral Sciences, Chang Gung University
      • Contact: Yi-Jen Su, Ph.D.; Phone Number: 3421 +886-3-2118800; Email: suyijen@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary diagnosis of DSM-5 PTSD, with moderate to severe symptoms for at least 3 months

Exclusion Criteria:

• organic mental disorder, current substance dependence, psychosis, acute suicidality (i.e., suicidal ideation with intent and plan), and severe dissociation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 60-minute Prolonged Exposure Therapy; This condition is a modified version of Prolonged Exposure Therapy for PTSD. It consists of weekly 60-minute sessions, with at least 20 minutes imaginal exposure.	Behavioral: Prolonged Exposure Therapy; PE consists of 10-15 treatment sessions. Treatment includes psychoeducation, in vivo exposure (i.e., confronting trauma-related situations and objects that are being avoided), imaginal exposure (i.e., revisiting and recounting traumatic memory) followed by processing (discussing the experience of revisiting the trauma memory, with a focus on new learning and changed beliefs or perspectives).
ACTIVE_COMPARATOR: 90-minute Prolonged Exposure Therapy; This condition is standard Prolonged Exposure Therapy. It consists of 10 to 15 weekly sessions, each lasting about 90 minutes, with 40-60 minutes imaginal exposure.	Behavioral: Prolonged Exposure Therapy; PE consists of 10-15 treatment sessions. Treatment includes psychoeducation, in vivo exposure (i.e., confronting trauma-related situations and objects that are being avoided), imaginal exposure (i.e., revisiting and recounting traumatic memory) followed by processing (discussing the experience of revisiting the trauma memory, with a focus on new learning and changed beliefs or perspectives).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interviewer-assessed PTSD diagnosis and symptoms	as measured by the Chinese version of the PTSD Symptoms Scale Interview for DSM-5 (PSSI-5) (Foa et al., 2016). The tota score ranged from 0 to 80, with higher scores indicating greater PTSD symptoms.	Pre-treatment through three-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported PTSD symptoms	as measure by the Chinese version of the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5; Foa et al., 2016). The tota score ranged from 0 to 80, with higher scores indicating greater PTSD symptoms.	Pre-treatment through three-month follow-up
Self-reported depressive symptoms	as measure by the Chinese version of the Beck Depression Inventory-II (Beck, Steer, & Brown, 1996). The tota score ranged from 0 to 63, with higher scores indicating greater depressive symptoms.	Pre-treatment through three-month follow-up
Self-reported posttraumatic growth	as measured by the Chinese version of the Expanded Posttraumatic Growth Inventory. The total score ranged from 0 to 75, with higher scores indicating greater trauma-related growth.	Pre-treatment through three-month follow-up
Self-reported posttraumtic negative cognitions	as measured by the Chinese version of the Posttraumatic Cognition Inventory. The total score ranged from 33 to 231, with higher scores indicating greater posttraumatic negative cognitions.	Pre-treatment through three-month follow-up

Collaborators and Investigators

• Sponsor: Chang Gung University
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Yi-Jen Su, Ph.D., Chang Gung University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 10, 2018
• Primary Completion (ANTICIPATED): November 30, 2018
• Study Completion (ANTICIPATED): November 30, 2018

Study Registration Dates

• First Submitted: December 30, 2017
• First Submitted That Met QC Criteria: December 30, 2017
• First Posted (ACTUAL): January 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: PTSD; prolonged exposure; posttraumatic growth
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MOST 106-2628-H-182-001-SS2

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