Posttraumatic Stress DisorderNCT03391297
Shortened Prolonged Exposure Therapy for Chronic PTSD in Taiwanese Adults
A study testing Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder, run by Chang Gung University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of DSM-5 PTSD, with moderate to severe symptoms for at least 3 months
Who cannot join
- organic mental disorder, current substance dependence, psychosis, acute suicidality (i.e., suicidal ideation with intent and plan), and severe dissociation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Graduate Institute of Behavioral Sciences, Chang Gung University
Taoyuan, Guishan Dist., 33302
Yi-Jen Su, Ph.D., +886-3-2118800 ext. 3421, suyijen@mail.cgu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Prolonged Exposure Therapy
- Keywords
- PTSD; prolonged exposure; posttraumatic growth
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment through three-month follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment through three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start10 Jan 2018 (estimated)
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Yi-Jen Su, Chang Gung University
- Investigators
- Yi-Jen Su, Ph.D., Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391297
- Sponsor's protocol ID
- MOST 106-2628-H-182-001-SS2
- Status last verified
- Jan 2018
- First submitted
- 30 Dec 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortened Prolonged Exposure Therapy for Chronic PTSD: A Systematic Case Study
- ClinicalTrials.gov ID
- NCT03391297
- Acronym / sponsor ID
- MOST 106-2628-H-182-001-SS2
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD; prolonged exposure; posttraumatic growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 10 Jan 2018 (estimated)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 60-minute Prolonged Exposure Therapy | Experimental | Behavioral: Prolonged Exposure TherapyThis 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. |
| 90-minute Prolonged Exposure Therapy | Active comparator | Behavioral: Prolonged Exposure TherapyThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary diagnosis of DSM-5 PTSD, with moderate to severe symptoms for at least 3 months
Key exclusion criteria (1 listed)
- organic mental disorder, current substance dependence, psychosis, acute suicidality (i.e., suicidal ideation with intent and plan), and severe dissociation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyPE 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). | Behavioural | 60-minute Prolonged Exposure Therapy, 90-minute Prolonged Exposure Therapy |
Primary outcome
Interviewer-assessed PTSD diagnosis and symptoms
Time frame: Pre-treatment through three-month follow-up
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.
4 secondary outcomes
Self-reported PTSD symptoms
Time frame: Pre-treatment through three-month follow-up
Self-reported depressive symptoms
Time frame: Pre-treatment through three-month follow-up
Self-reported posttraumatic growth
Time frame: Pre-treatment through three-month follow-up
Self-reported posttraumtic negative cognitions
Time frame: Pre-treatment through three-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Jen Su, Ph.D. principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Jen Su, Ph.D. (+886-3-2118800 ext. 3421, suyijen@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interviewer-assessed PTSD diagnosis and symptoms (time frame: Pre-treatment through three-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.