Exploring outcomes of a self-guided online course for adults with posttraumatic stress symptoms
| ISRCTN | ISRCTN53622359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53622359 |
| Sponsor | Brigham Young University |
| Funder | Brigham Young University |
- Submission date
- 21/07/2026
- Registration date
- 22/07/2026
- Last edited
- 22/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Posttraumatic stress can affect a person's thoughts, emotions, relationships, and daily life. Cognitive Processing Therapy (CPT) is a well-established and well-validated psychological treatment that helps people identify and reconsider unhelpful beliefs linked to traumatic experiencs. It is usually delivered via a psychotherapist, whether individually or in groups. However, many people experience barriers to accessing this and other psychological interventions because of cost, location, waiting lists, limited availability, or concerns about stigma.
This study explored the outcomes of a fully self-led online version of a CPT workbook that was published by Guilford Press in 2023. This modality has been under studied. The main aim of this study was to examine whether adults report changes in PTSD symptoms and general psychological functioning while completing the treatment course. The study compared people who received immediate access to the treatment with people who waited before receiving it. It also examined participation in and completion of the course.
Who can participate?
Adults ages 18 years or older of any sex/gender, provided they:
1. live in the US
2. can complete the study materials in English
3. report at least one traumatic experience involving actual or threatened death, serious injury, or sexual violence
4. had elevated PTSD symptoms on a screening questionnaire
What does the study involve?
All study activities take place online. After completing screening and initial questionnaires, eligible participants are assigned by a compter program to one of two groups: the Intervention and the Waitlist. All participants complete questionnaires about their PTSD symptoms and broader psychological funcitoning before and after the course.
The Intervention group receives immediate access to the 12-week treatment via an online course platform that divided the content into modules. The materials include educational material, structured exercises, videos, and biographical examples.
The waitlist group receives delayed access. Each week for 12 weeks, they are sent a PCL-5 with which to track their symptoms. After 12 weeks, the waitlist group receive access to the treatment.
What are the possible risks and benefits of participating?
Participants may gain a better understanding of their trauma-related thoughts, emotions, and coping patterns. They might also experience improvement in their symptoms or daily functioning, but direct benefit was not guaranteed. The study could help researchers understand whether a self-guided course may offer a more accessible form of support for people struggling with PTSD symptoms.
However, thinking about traumatic experiences and completing course exercises may cause temporary emotional discomfort or distress. Repeated questionnaires could also cause tiredness or frustration. As with any online study, there is also a small risk that private information could be exposed via data breaches.
Participants receive information about crisis and support services, and the research team is prepared to intervene if a participant discloses imminent harm to vulnerable populations. Participants are informed of possible emotional distress, fatigue, privacy concerns, and these reporting responsibilities. Those who completed all required course activities and assessments are offered a $100 electronic gift card. Partial payment is not provided for incomplete participation.
Where is the study run from?
The Department of Psychology at Brigham Young University in Provo, Utah, United States of America.
When is the study starting and how long is it expected to run for?
February 2025 to December 2025.
Who is funding the study?
The Department of Psychology at Brigham Young University in Provo, Utah, United States of America.
Who is the main contact?
Melissa Goates-Jones, cpt-study@byu.edu
Contact information
Principal investigator, Scientific, Public
Campus Dr 1001 KMBL
Provo
84604
United States of America
| Phone | +1 (801) 422-4287 |
|---|---|
| cpt-study@byu.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Randomized delayed-access waitlist design; participants were assigned to immediate intervention or a 12-week waitlist followed by access to the same intervention. |
| Purpose | Treatment |
| Participant information sheet | 49964 PIS.pdf |
| Scientific title | Posttraumatic stress and psychological functioning among trauma-exposed adults receiving immediate or delayed access to a self-led online cognitive processing therapy workbook |
| Study objectives | To evaluate whether a fully self-led online course with content of a Cognitive Processing Therapy recovery workbook is associated with reductions in posttraumatic stress symptoms and improvements in overall psychological functioning among trauma-exposed adults with clinically elevated PTSD symptoms. The study also examines course engagement and completion. Participants assigned to delayed access served as a waitlist comparison during the initial 12-week period and subsequently received access to the intervention. |
| Ethics approval(s) |
Approved 24/01/2025, Brigham Young University Institutional Review Board; Human Research Protection Program (Room 121, South Campus Office Building (SCOB)735 N 500 E, Provo, 84602, United States of America; +1 8014221461; BYU.HRPP@byu.edu), ref: IRB2024-420 |
| Health condition(s) or problem(s) studied | Posttraumatic stress symptoms following exposure to a DSM-5 Criterion A traumatic event |
| Intervention | Eligible participants are allocated to either immediate access to a 12-week self-led online course or a 12-week delayed-access waitlist condition. The online course uses exact content from the Guilford Press workbook: "Getting Unstuck from PTSD: Using Cognitive Processing Therapy to Guide Your Recovery." Participants are asked to complete one module per week, with each module taking approximately 60 minutes. They were also asked to take weekly PCL-5 measures (per "Getting Unstuck" protocol). Getting Unstuck from PTSD Chapter Titles Chapter Title Part 1: Introduction: How People Get Stuck In PTSD and How to Get Unstuck 1 Overview of CPT 2 How PTSD Keeps You Stuck 3 Making a Plan to Get Unstuck from PTSD Part 2: Identifying Where You Are Stuck 4 Introduction to PTSD and Trauma Recovery 5 Processing the Meaning of Your Trauma and Building a Stuck Point Log 6 Identifying Thoughts and Feelings Part 3: Getting Unstuck from Beliefs about the Trauma 7 Beginning to Examine Your Worst Traumatic Event 8 The Exploring Questions Worksheet 9 Introducing Thinking Patterns Part 4: Getting Unstuck from Trauma-Related Beliefs about the Present and Future 10 Using the Alternative Thoughts Worksheet to Balance Your Thinking 11 Safety 12 Trust 13 Power and Control 14 Esteem 15 Intimacy Part 5: Moving Forward 16 Finishing Cognitive Processing Therapy 17 Conclusion Participants in the immediate-access group begin the course after baseline assessment via the Outcome Questionnaire-45 (OQ-45) and Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5). Participants in the delayed-access group complete weekly PCL-5 assessments during a 12-week no-intervention waiting period and then received access to the same course. Participants in the Intervention group also complete weekly PCL-5 assessments. Overall psychological functioning is assessed using the Outcome Questionnaire-45 at baseline and at the end of the intervention or waitlist period. Course engagement and completion are also recorded. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 05/12/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 182 |
| Total final enrolment | 1027 |
| Key inclusion criteria | 1. Ages 18+years 2. Residing in the United States 3. Able to read and complete study procedures in English 4. Exposure to at least one DSM-5-TR Criterion A traumatic event, assessed using the Life Events Checklist for DSM-5 (LEC-5) 5. Clinically Elevated PTSD symptoms, defined as a PTSD Checklist for DSM-5 score of 31 or higher 6. Able to access and complete the study procedures and intervention online 7. Not currently receiving psychotherapy or other psychological treatment |
| Key exclusion criteria | 1. Younger than 18 years old 2. Not residing in the United States 3. Self-reported low proficiency in English reading and/or writing 4. No qualifying DSM-5 Criterion A traumatic event 5. PTSD Checklist for DSM-5 score below 31 6. Currently receiving psychotherapy or psychological treatment for PTSD 7. Recent active suicidality (self-reported) 8. Change in psychotropic medication during the preceding 6 weeks, or change in medication during the study 9. Imminent risk of harm to self or others (self-reported) 10. Unable to complete the online study procedures as outline in the informed consent (e.g., completion of the intervention) |
| Date of first enrolment | 20/02/2025 |
| Date of final enrolment | 30/05/2025 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 22/07/2026 | No | Yes |
Additional files
- 49964 PIS.pdf
- Participant information sheet
Editorial Notes
22/07/2026: Trial's existence confirmed by Brigham Young University Institutional Review Board.
