Psychological TraumaNCT05670405
The Trauma PORTAL Project: a Virtual Asynchronous Treatment for Interpersonal Trauma
A study testing The Trauma PORTAL in people with Psychological Trauma, run by Women's College Hospital at 1 site in Canada.
Trial summary
Virtual delivery of mental health care is an emerging strategy for increasing access and enhancing the delivery of mental health services; however, evidence that virtual interventions are an efficacious form of therapy is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- The Trauma PORTAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2023to 20 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18 years old; and
- Self-report childhood interpersonal trauma (physical, sexual, emotional, neglect) prior to age 18; and
- A diagnosis of PTSD aligned with the Mini International Neuropsychiatric Interview Module H; and
- Access to appropriate device and internet connection to access the intervention; and
- Attended an orientation session for the Trauma Therapy Program at WCH; and
- Suitable for Trauma PORTAL intervention (confirmed by clinical assessment with a TTP Therapist)*
- Participants will not be included if, based on a clinical assessment with a TTP therapist, there is a concern that the participant has: (1) significant difficulty with self-regulation which make them unsuitable for an outpatient asynchronous intervention, (2) cognitive impairments that would impede understanding and processing of educational material, (3) significant case management needs that would result in lack of suitability for asynchronous online group therapy, or (4) for any other clinical reason, at the discretion of the assessing TTP therapist.
Who cannot join
- Have had active alcohol or substance use disorder in the past 3 months; or
- Have active symptoms of mania or psychosis, or active suicidal ideation; or
- Have had psychiatric hospitalization in the past 6 months; or
- Are unable to complete study procedures in English (intervention not yet translated)
- Previously completed an R\&R group with an approved provider
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Trauma PORTAL Project: A Randomized Controlled Trial of a Virtual Asynchronous Psychoeducational Psychotherapy Treatment for Survivors of Childhood Interpersonal Trauma
Virtual delivery of mental health care is an emerging strategy for increasing access and enhancing the delivery of mental health services; however, evidence that virtual interventions are an efficacious form of therapy is limited. An asynchronous virtual treatment program that allows patients to access program material at any time could be a widely accessible, cost-effective alternative to in-person or synchronous virtual group therapy. The Trauma Therapy Program (TTP) at Women's College Hospital (WCH) follows clinical guidelines for the treatment of complex post-traumatic stress disorder that recommend a staged approach to treatment for adults suffering from the sequelae of childhood interpersonal trauma (CIT). The initial stage is safety and stabilization; in TTP, this begins with the Resourced and Resilient (R\&R) group, a stage 1 trauma-focused psychoeducational psychotherapy group. Psychoeducational psychotherapy is a widely used approach to help patients understand the impact of trauma, challenge maladaptive behaviour patterns, learn safer coping skills and reduce trauma-related symptoms as part of a comprehensive approach to the treatment of PTSD. To address gaps in equitable access to trauma-focused care, the investigators developed the Trauma PORTAL: Providing Online tRauma Therapy using an Asynchronous Learning platform. The investigators developed an asynchronous virtual multimedia version of R\&R consisting of 8 modules, called the Trauma PORTAL; previously called electronic Resourced and Resilient or e-R\&R. The investigators then conducted an open-label pilot study where the Trauma PORTAL intervention was offered that included access to the asynchronous virtual modules, along with an optional weekly 1-hour synchronous virtual group that offers patients an opportunity to ask questions about content from the modules. Preliminary data from the investigators' open-label eR\&R pilot study demonstrates feasibility, usability, and acceptability, as well as a significant improvement in PTSD symptoms from pre- to post-group. This phase of the Trauma PORTAL project seeks to test the efficacy and further assess the intervention processes, including recruitment, retention, acceptability, and adherence to the Trauma PORTAL intervention through a randomized controlled trial.
Read the detailed description
The investigators aim to conduct a randomized controlled trial to determine the efficacy of the Trauma PORTAL intervention. The Trauma PORTAL is an asynchronous virtual multimedia version of the stage 1 trauma-focused psychoeducational psychotherapy group called Resourced \& Resilient (R\&R) in the Trauma Therapy Program (TTP) at Women's College Hospital (WCH). The TTP is a specialized trauma-focused therapy service for persons with childhood histories of trauma. The program offers confidential, time-limited and primarily group-based psychotherapy to adults who have experienced childhood interpersonal trauma, including physical, sexual, and emotional abuse and/or neglect that occurred between the ages of 0-18. The TTP comprises an interdisciplinary team of trauma therapists with backgrounds in psychiatry, psychotherapy, psychology, social work, and nursing.
The Trauma PORTAL intervention consists of 8 online modules that participants can complete at the participants own pace, with optional once-weekly "live" virtual sessions facilitated by trauma therapists in the TTP. The investigators specifically aim to measure clinical symptoms to generate estimates of the effect of the Trauma PORTAL intervention on clinical measures of PTSD, depression, anxiety, and emotion regulation compared to a care-as-usual condition. The investigators will also evaluate the intervention processes, including recruitment, retention, acceptability and adherence to inform spread and scale post-trial if the intervention is demonstrated to be effective.
Individuals will be recruited from the waitlist for the "live" synchronous virtual or in-person R\&R group in the TTP.
Individuals will be randomized to receive the Trauma PORTAL intervention (immediate treatment condition, ITC) or treatment as usual while on a waitlist (care-as-usual condition, CUC). Participants randomized to CUC will remain on the waitlist for live R\&R and complete clinical measures at the same time points as the ITC group. All participants will complete clinical measures at baseline, 8 weeks, and 16 weeks.
- Conditions
- Psychological Trauma
- Being tested
- The Trauma PORTAL
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Trauma PORTALOther
Participants will have 9 weeks to complete the 8 modules which each take on average 45 minutes to complete. Each module consists of psychoeducational handouts, videos, interactive exercises, and discussion topics that has been adapted from the R\&R curriculum. The participants will also receive a pdf of the handouts from the modules, which can be used to take notes or refer back to in the future.
There will be an optional 60-minute weekly virtual group session for participants to engage with other participants in their group and for group facilitator providers to discuss the materials covered and answer any questions. Participants will join a Zoom video group visit to access the group. Each weekly group will be facilitated by 2 clinicians specializing in trauma-focused therapy within the WCH TTP who have extensive experience with in-person and virtual synchronous R\&R.
| Study group | Role | What they receive |
|---|---|---|
| Trauma PORTAL Intervention | Experimental | The treatment group will complete the Trauma PORTAL intervention in 9 weeks. The participants will be asked to complete clinical measures at baseline, 8 weeks, and 16 weeks. Receives: Other: The Trauma PORTAL |
| Care-as-Usual | No intervention | The control group will receive care-as-usual, remaining on the waitlist for the regular TTP R\&R groups. Participants in the CUC group will be asked to complete clinical measures at time points corresponding to the ITC group's baseline (prior to starting week one) and post-intervention (i.e. primary endpoint, end of week 8). Both groups will complete the clinical measures eight weeks later (16-week time point). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The min and max values are 0 and 80, with higher scores indicating worse outcome.
Measured: At baseline, week 8 and week 16
Secondary outcomes (3)
Change in Clinician-Administered Post-Traumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Past Month score (CAPS-5 Past Month) score
The CAPS-5 - Past Month score is a 30-item structured interview that can be used to make a current (past month) or lifetime diagnosis of PTSD and assess PTSD symptoms over the past week. The min and max values are 0 to 80, with higher scores indicating worse outcome.
Measured: At baseline, week 8 and week 16
Change in Difficulties in Emotion Regulation Scale (DERS-18) score
The DERS-18 is a multi-dimensional assessment of emotion regulation and dysregulation. It consists of a self-reported 18-item questionnaire that assesses 6 subscales: lack of awareness of one's emotions, lack of clarity about the nature of one's emotions, lack of acceptance of one's emotions, lack of access to effective emotion regulation strategies, lack of ability to engage in goal-directed activities during negative emotions, and lack of ability to manage one's impulses during negative emotions. Each subscale consists of 3 items, which are rated on a scale of 1 (almost never) to 5 (almost always). The min and max values are 18 and 90, with higher scores indicating worse outcome.
Measured: At baseline, week 8 and week 16
Change in Short Self-Compassion Scale (Short SCS) score
The Short SCS is a 12-item survey assessing 6 subscales: self-judgement, self-kindness, common humanity, isolation, mindfulness, and overidentification. Questions are rated on a 5-point scale ranging from 1 (almost never) to 5 (almost always) with subscale scores computed by calculating the mean of subscale item responses. The min and max values are 12 and 60, with higher scores indicating greater self-compassion.
Measured: At baseline, week 8 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start16 Jan 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological TraumaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Ross, Women's College Hospital
- Investigators
- Dana C. Ross, MD, MSc, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670405
- Sponsor's protocol ID
- 2022-0083-E
- Status last verified
- May 2024
- First submitted
- 30 Nov 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ross DC, Sayrafizadeh N, Waliji LA, Farhat K, Truuvert AK, Musheer M, Vigod SN, Chu C, Soklaridis S, Rojas D, McCallum N. Efficacy of a hybrid psychoeducational and skills-based therapy (Trauma PORTAL) for adults with PTSD related to childhood interpersonal trauma: a parallel-group, randomised controlled trial. EClinicalMedicine. 2026 Jun 5;96:104003. doi: 10.1016/j.eclinm.2026.104003. eCollection 2026 Jun.
PubMed 42306493
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trauma PORTAL Project: A Randomized Controlled Trial of a Virtual Asynchronous Psychoeducational Psychotherapy Treatment for Survivors of Childhood Interpersonal Trauma
- ClinicalTrials.gov ID
- NCT05670405
- Acronym / sponsor ID
- 2022-0083-E
- Conditions
- Psychological Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 4 Jan 2023 (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.
Virtual delivery of mental health care is an emerging strategy for increasing access and enhancing the delivery of mental health services; however, evidence that virtual interventions are an efficacious form of therapy is limited. An asynchronous virtual treatment program that allows patients to access program material at any time could be a widely accessible, cost-effective alternative to in-person or synchronous virtual group therapy. The Trauma Therapy Program (TTP) at Women's College Hospital (WCH) follows clinical guidelines for the treatment of complex post-traumatic stress disorder that recommend a staged approach to treatment for adults suffering from the sequelae of childhood interpersonal trauma (CIT). The initial stage is safety and stabilization; in TTP, this begins with the Resourced and Resilient (R\&R) group, a stage 1 trauma-focused psychoeducational psychotherapy group. Psychoeducational psychotherapy is a widely used approach to help patients understand the impact of trauma, challenge maladaptive behaviour patterns, learn safer coping skills and reduce trauma-related symptoms as part of a comprehensive approach to the treatment of PTSD. To address gaps in equitable access to trauma-focused care, the investigators developed the Trauma PORTAL: Providing Online tRauma Therapy using an Asynchronous Learning platform. The investigators developed an asynchronous virtual multimedia version of R\&R consisting of 8 modules, called the Trauma PORTAL; previously called electronic Resourced and Resilient or e-R\&R. The investigators then conducted an open-label pilot study where the Trauma PORTAL intervention was offered that included access to the asynchronous virtual modules, along with an optional weekly 1-hour synchronous virtual group that offers patients an opportunity to ask questions about content from the modules. Preliminary data from the investigators' open-label eR\&R pilot study demonstrates feasibility, usability, and acceptability, as well as a significant improvement in PTSD symptoms from pre- to post-group. This phase of the Trauma PORTAL project seeks to test the efficacy and further assess the intervention processes, including recruitment, retention, acceptability, and adherence to the Trauma PORTAL intervention through a randomized controlled trial.
Detailed description
The investigators aim to conduct a randomized controlled trial to determine the efficacy of the Trauma PORTAL intervention. The Trauma PORTAL is an asynchronous virtual multimedia version of the stage 1 trauma-focused psychoeducational psychotherapy group called Resourced \& Resilient (R\&R) in the Trauma Therapy Program (TTP) at Women's College Hospital (WCH). The TTP is a specialized trauma-focused therapy service for persons with childhood histories of trauma. The program offers confidential, time-limited and primarily group-based psychotherapy to adults who have experienced childhood interpersonal trauma, including physical, sexual, and emotional abuse and/or neglect that occurred between the ages of 0-18. The TTP comprises an interdisciplinary team of trauma therapists with backgrounds in psychiatry, psychotherapy, psychology, social work, and nursing.
The Trauma PORTAL intervention consists of 8 online modules that participants can complete at the participants own pace, with optional once-weekly "live" virtual sessions facilitated by trauma therapists in the TTP. The investigators specifically aim to measure clinical symptoms to generate estimates of the effect of the Trauma PORTAL intervention on clinical measures of PTSD, depression, anxiety, and emotion regulation compared to a care-as-usual condition. The investigators will also evaluate the intervention processes, including recruitment, retention, acceptability and adherence to inform spread and scale post-trial if the intervention is demonstrated to be effective.
Individuals will be recruited from the waitlist for the "live" synchronous virtual or in-person R\&R group in the TTP.
Individuals will be randomized to receive the Trauma PORTAL intervention (immediate treatment condition, ITC) or treatment as usual while on a waitlist (care-as-usual condition, CUC). Participants randomized to CUC will remain on the waitlist for live R\&R and complete clinical measures at the same time points as the ITC group. All participants will complete clinical measures at baseline, 8 weeks, and 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma PORTAL Intervention | Experimental | Other: The Trauma PORTALThe treatment group will complete the Trauma PORTAL intervention in 9 weeks. The participants will be asked to complete clinical measures at baseline, 8 weeks, and 16 weeks. |
| Care-as-Usual | No intervention | –The control group will receive care-as-usual, remaining on the waitlist for the regular TTP R\&R groups. Participants in the CUC group will be asked to complete clinical measures at time points corresponding to the ITC group's baseline (prior to starting week one) and post-intervention (i.e. primary endpoint, end of week 8). Both groups will complete the clinical measures eight weeks later (16-week time point). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged > 18 years old; and
- Self-report childhood interpersonal trauma (physical, sexual, emotional, neglect) prior to age 18; and
- A diagnosis of PTSD aligned with the Mini International Neuropsychiatric Interview Module H; and
- Access to appropriate device and internet connection to access the intervention; and
- Attended an orientation session for the Trauma Therapy Program at WCH; and
Key exclusion criteria (5 listed)
- Have had active alcohol or substance use disorder in the past 3 months; or
- Have active symptoms of mania or psychosis, or active suicidal ideation; or
- Have had psychiatric hospitalization in the past 6 months; or
- Are unable to complete study procedures in English (intervention not yet translated)
- Previously completed an R\&R group with an approved provider
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 |
|---|---|---|
| The Trauma PORTALParticipants will have 9 weeks to complete the 8 modules which each take on average 45 minutes to complete. Each module consists of psychoeducational handouts, videos, interactive exercises, and discussion topics that has been adapted from the R\&R curriculum. The participants will also receive a pdf of the handouts from the modules, which can be used to take notes or refer back to in the future. There will be an optional 60-minute weekly virtual group session for participants to engage with other participants in their group and for group facilitator providers to discuss the materials covered and answer any questions. Participants will join a Zoom video group visit to access the group. Each weekly group will be facilitated by 2 clinicians specializing in trauma-focused therapy within the WCH TTP who have extensive experience with in-person and virtual synchronous R\&R. | Other | Trauma PORTAL Intervention |
Primary outcome
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
Time frame: At baseline, week 8 and week 16
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The min and max values are 0 and 80, with higher scores indicating worse outcome.
3 secondary outcomes
Change in Clinician-Administered Post-Traumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Past Month score (CAPS-5 Past Month) score
Time frame: At baseline, week 8 and week 16
Change in Difficulties in Emotion Regulation Scale (DERS-18) score
Time frame: At baseline, week 8 and week 16
Change in Short Self-Compassion Scale (Short SCS) score
Time frame: At baseline, week 8 and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 42306493Ross DC, Sayrafizadeh N, Waliji LA, Farhat K, Truuvert AK, Musheer M, Vigod SN, Chu C, Soklaridis S, Rojas D, McCallum N. Efficacy of a hybrid psychoeducational and skills-based therapy (Trauma PORTAL) for adults with PTSD related to childhood interpersonal trauma: a parallel-group, randomised controlled trial. EClinicalMedicine. 2026 Jun 5;96:104003. doi: 10.1016/j.eclinm.2026.104003. eCollection 2026 Jun.
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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.
Dana C. Ross, MD, MSc principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Trauma PORTAL in people with Psychological Trauma, run by Women's College Hospital at 1 site in Canada.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 3 May 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score (time frame: At baseline, week 8 and week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670405, which also lists 1 linked publication.
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 3 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.