Shortened Prolonged Exposure Therapy for Chronic PTSD in Taiwanese Adults
Primary Purpose
Posttraumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD; prolonged exposure; posttraumatic growth
Eligibility Criteria
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.
Sites / Locations
- Graduate Institute of Behavioral Sciences, Chang Gung UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
60-minute Prolonged Exposure Therapy
90-minute Prolonged Exposure Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03391297
First Posted
December 30, 2017
Last Updated
January 4, 2018
Sponsor
Chang Gung University
Collaborators
Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03391297
Brief Title
Shortened Prolonged Exposure Therapy for Chronic PTSD in Taiwanese Adults
Official Title
Shortened Prolonged Exposure Therapy for Chronic PTSD: A Systematic Case Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2018 (Anticipated)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University
Collaborators
Ministry of Science and Technology, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD; prolonged exposure; posttraumatic growth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prolonged exposure therapy (PE), a specific exposure therapy for PTSD, has been proved an effective treatment for PTSD. PE usually consists of 10-15 individual 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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
60-minute Prolonged Exposure Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
90-minute Prolonged Exposure Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Interviewer-assessed PTSD diagnosis and symptoms
Description
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.
Time Frame
Pre-treatment through three-month follow-up
Secondary Outcome Measure Information:
Title
Self-reported PTSD symptoms
Description
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.
Time Frame
Pre-treatment through three-month follow-up
Title
Self-reported depressive symptoms
Description
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.
Time Frame
Pre-treatment through three-month follow-up
Title
Self-reported posttraumatic growth
Description
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.
Time Frame
Pre-treatment through three-month follow-up
Title
Self-reported posttraumtic negative cognitions
Description
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.
Time Frame
Pre-treatment through three-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Jen Su, Ph.D.
Phone
+886-3-2118800
Ext
3421
Email
suyijen@mail.cgu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Su, Ph.D.
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Institute of Behavioral Sciences, Chang Gung University
City
Taoyuan
State/Province
Guishan Dist.
ZIP/Postal Code
33302
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Su, Ph.D.
Phone
+886-3-2118800
Ext
3421
Email
suyijen@mail.cgu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shortened Prolonged Exposure Therapy for Chronic PTSD in Taiwanese Adults
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