Shortened Prolonged Exposure Therapy for Chronic PTSD in Taiwanese Adults

NCT03391297 | Unknown DMC

• 1 other identifier: MOST 106-2628-H-182-001-SS2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; prolonged exposure; posttraumatic growth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Self-reported PTSD symptoms

  Pre-treatment through three-month follow-up

• Self-reported depressive symptoms

  Pre-treatment through three-month follow-up

• Self-reported posttraumatic growth

  Pre-treatment through three-month follow-up

• Self-reported posttraumtic negative cognitions

  Pre-treatment through three-month follow-up

Study Arms (2)

60-minute Prolonged Exposure Therapy

EXPERIMENTAL

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

90-minute Prolonged Exposure Therapy

ACTIVE COMPARATOR

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

Interventions

Prolonged Exposure Therapy BEHAVIORAL

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).

60-minute Prolonged Exposure Therapy; 90-minute Prolonged Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Graduate Institute of Behavioral Sciences, Chang Gung University

Taoyuan District, Guishan Dist., 33302, Taiwan

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yi-Jen Su, Ph.D.

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Jen Su, Ph.D.

CONTACT

+886-3-2118800; suyijen@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: January 5, 2018
• Study Start: January 10, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)