Posttraumatic Stress DisorderNCT05625126
Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series
A study testing Rumination Intervention for individuals with PTSD in people with Posttraumatic Stress Disorder and Rumination - Thoughts, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
After a traumatic event, it is common for thoughts to run through our minds over and over again. Typically, these include unanswerable questions like "why did this happen to me?", "what if I had done something differently?" Dwelling or ruminating on the past like this is often unhelpful and research has shown that it… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Rumination - Thoughts
- What is being tested?
- Rumination Intervention for individuals with PTSD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Dec 2022to 30 Jun 2023
- 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
- Willing and able to give informed consent for participation in the trial.
- Willing and able to complete an online measures, online training and a phone or video call (this includes access to internet and to a computer, laptop, tablet or phone).
- Aged 18-65 years.
- English speakers and ability to read and write in English.
- Availability to participate in 6-8 weeks of this study.
- Suspected primary diagnosis of PTSD
Show all 10Show fewer
- Currently on the waitlist for Step 3 individual PTSD treatment in an Improving Access to Psychological Therapies (IAPT) service at the Oxford Health NHS Trust or Berkshire Healthcare Foundation Trust
- Individuals must still have 9+ weeks left on the waitlist so start of PTSD treatment will not interfere with the study.
- Score above cut-off for PTSD symptoms at screening (by scoring 33 or above on the PCL-5 scores)
- Showing high rumination (by scoring "often" or "always" on any item of the RIQ)
Who cannot join
- If it appears that a different disorder/mental health condition (not PTSD) is primary (e.g. depression, substance use).
- Any other significant disease or disorder which, in the opinion of the investigators, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Talking Therapies, Berkshire Healthcare NHS Foundation Trust
Bracknell, Berkshire, RG12 1QB
Healthy Minds, Oxford Health NHS Foundation Trust
High Wycombe, HP13 6LA
About this study
After a traumatic event, it is common for thoughts to run through our minds over and over again. Typically, these include unanswerable questions like "why did this happen to me?", "what if I had done something differently?" Dwelling or ruminating on the past like this is often unhelpful and research has shown that it increases our chances of developing posttraumatic stress disorder (PTSD), a debilitating stress reaction. Once PTSD is in place, research shows that ruminating keeps the disorder going. It is unknown to what extent targeting rumination with an intervention to reduce its recurrence may help to alleviate PTSD symptoms. While rumination interventions using evidence-based cognitive behavioural therapy (CBT) have shown highly promising results in depression and anxiety research, no previous study has evaluated a stand-alone rumination intervention for individuals with PTSD.
The aim of this study is to examine the impact of a one-session online Rumination Intervention designed to reduce rumination in a small sample of 14 individuals who are currently awaiting treatment for PTSD in a British national mental health (NHS) service. The study will explore whether the Rumination Intervention reduces PTSD-related rumination, as well as PTSD and depression symptoms. It will also investigate how feasible and acceptable the intervention is for participants.
If the findings are promising, the intervention could be tested in a larger clinical study in the future. Results may help inform online interventions for PTSD.
Read the detailed description
Please note: This study adopts a within and between-subjects concurrent multiple baseline A-B design will be used for this study. Due to the format of a case series, there will be no control group and no blinding. Participants will be compared to their own baseline (within) and between groups (delayed baseline for arm 2), meaning that individuals with a 3-week baseline will be compared to individuals with a 5-week baseline. This will be an experimental framework.
- Being tested
- Rumination Intervention for individuals with PTSD
- 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.
Rumination Intervention for individuals with PTSDOther
The intervention utilises evidence-based cognitive behavioural therapy (CBT) techniques.
| Study group | Role | What they receive |
|---|---|---|
| Rumination Invervention - 3 week baseline | Experimental | Baseline measures will be collected weekly for 3 weeks.
All participants will then receive a one-session online Rumination Intervention for PTSD with a follow-up call to clarify/solidify learning. Receives: Other: Rumination Intervention for individuals with PTSD |
| Rumination Invervention - 5 week baseline | Experimental | Baseline measures will be collected weekly for 5 weeks.
All participants will then receive a one-session online Rumination Intervention for PTSD with a follow-up call to clarify/solidify learning. Receives: Other: Rumination Intervention for individuals with PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly change of rumination: Response to Intrusion Questionnaire (RIQ; Clohessy & Ehlers, 1999; Murray et al., 2002; Steil & Ehlers, 2000)
The RIQ is a 19-item self-report measure which examines responses to intrusive memories. It is divided into three subscales: suppression (6 items), rumination (6-8 items) and dissociation (5 items) which are scored on a scale from 0=never to 3=always. The scales have demonstrated adequate reliability and predictive validity in a range of studies (Beierl et al., 2019; Ehring, Ehlers, et al., 2008; Kleim et al., 2007). The internal consistency of the rumination subscale was between α=.80-.86. For the current study, only the 6-item rumination subscale will be used, in line with the measure recommended on the website of the Oxford Centre for Anxiety Disorder and Trauma (OxCADAT), who developed the measure. For the current study, the "high rumination" inclusion criteria was defined as individuals marking 2 (often) or 3 (always) on any of the 6 items.
Measured: At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Secondary outcomes (6)
Weekly change of repetitive negative thinking: Repetitive Thinking Questionnaire (RTQ-10; Mahoney et al., 2012; McEvoy et al., 2010)
The RTQ-10 is a transdiagnostic measure of repetitive negative thinking, focused on a distressing event. Items are rated along a 5-point scale: Not at all true (1), Somewhat true (3), or Very true (5). It showed good internal consistency (α=.72-.93), convergent validity, and predictive utility in a student sample (McEvoy et al., 2010). For the current study the 10-item short form is used (Mahoney et al., 2012) instead of the longer 31-item (McEvoy et al., 2010). The short scale was highly correlated with the full scale (r=.95, p < .001) in Mahoney et al., 2012.
Measured: Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Weekly change of time spent ruminating
One-item question assessing time spent ruminating per week (estimated hours/minutes)
Measured: Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Weekly change of PTSD: PTSD Scale for DSM-5 (PCL-5; Blevins et al., 2015)
The PCL-5 is a 20-item measure of PTSD symptoms directly corresponding to the DSM-5 PTSD criteria (American Psychiatric Association, 2013). Initial psychometric evaluation of the PCL-5 with university students exposed to trauma showed strong internal consistency (α=.94), and test- retest reliability (r=.82; Blevins et al., 2015). Symptoms are rated on a scale from 0=not at all to 4=extremely. A total score of 33 or more (out of a maximum score of 80) has been recommended as the preliminary clinical cut-off with higher scores indicting greater PTSD symptoms.
Measured: At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Pre-post change of depression: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
The PHQ-9 is a 9-item self-report questionnaire based on DSM-IV (American Psychiatric Association, 1994) criteria for depression. Scores range from 0=not at all to 3=nearly every day, with a score of 10 or more on the PHQ-9 indicating possible clinically significant depression with a sensitivity and specificity of 88% (Kroenke et al., 2001). Kroenke and team reported good internal reliability (α=.89) and test-retest reliability with a kappa of .84 after 48 hours.
Measured: Baseline week 1 and post-intervention week 2 (pre-post measure)
Adherence measure
One-item question on adherence (using the learned rumination techniques) post-intervention. The question on adherence is in line with the "acceptability" area of focus within a feasibility assessment, as recommended by Bowen and colleagues (2009).
Measured: Week 2 post-intervention (end of study)
Feasibility and acceptability measure
Questions on feasibility and acceptability based on examples by other authors (March et al., 2018; Miner et al., 2016). Questions are in line with guidance by Bowen and colleagues on how to design feasibility studies (Bowen et al., 2009) and relate to the feasibility areas of focus of "Acceptability" and "Practicality".
Measured: Week 2 post-intervention (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start7 Dec 2022
- Primary completion31 Mar 2023
- Study completion30 Jun 2023 (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.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Multiple baseline case series
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Health NHS Foundation Trust, Berkshire Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jennifer Wild, BS MEd DClin, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625126
- Sponsor's protocol ID
- 318316
- Status last verified
- Mar 2023
- First submitted
- 2 Nov 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series
- ClinicalTrials.gov ID
- NCT05625126
- Acronym / sponsor ID
- 318316
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford Health NHS Foundation Trust, Berkshire Healthcare NHS Foundation Trust
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Nov 2022 (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.
After a traumatic event, it is common for thoughts to run through our minds over and over again. Typically, these include unanswerable questions like "why did this happen to me?", "what if I had done something differently?" Dwelling or ruminating on the past like this is often unhelpful and research has shown that it increases our chances of developing posttraumatic stress disorder (PTSD), a debilitating stress reaction. Once PTSD is in place, research shows that ruminating keeps the disorder going. It is unknown to what extent targeting rumination with an intervention to reduce its recurrence may help to alleviate PTSD symptoms. While rumination interventions using evidence-based cognitive behavioural therapy (CBT) have shown highly promising results in depression and anxiety research, no previous study has evaluated a stand-alone rumination intervention for individuals with PTSD.
The aim of this study is to examine the impact of a one-session online Rumination Intervention designed to reduce rumination in a small sample of 14 individuals who are currently awaiting treatment for PTSD in a British national mental health (NHS) service. The study will explore whether the Rumination Intervention reduces PTSD-related rumination, as well as PTSD and depression symptoms. It will also investigate how feasible and acceptable the intervention is for participants.
If the findings are promising, the intervention could be tested in a larger clinical study in the future. Results may help inform online interventions for PTSD.
Detailed description
Please note: This study adopts a within and between-subjects concurrent multiple baseline A-B design will be used for this study. Due to the format of a case series, there will be no control group and no blinding. Participants will be compared to their own baseline (within) and between groups (delayed baseline for arm 2), meaning that individuals with a 3-week baseline will be compared to individuals with a 5-week baseline. This will be an experimental framework.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple baseline case series
| Arm | Type | Receives |
|---|---|---|
| Rumination Invervention - 3 week baseline | Experimental | Other: Rumination Intervention for individuals with PTSDBaseline measures will be collected weekly for 3 weeks. All participants will then receive a one-session online Rumination Intervention for PTSD with a follow-up call to clarify/solidify learning. |
| Rumination Invervention - 5 week baseline | Experimental | Other: Rumination Intervention for individuals with PTSDBaseline measures will be collected weekly for 5 weeks. All participants will then receive a one-session online Rumination Intervention for PTSD with a follow-up call to clarify/solidify learning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to give informed consent for participation in the trial.
- Willing and able to complete an online measures, online training and a phone or video call (this includes access to internet and to a computer, laptop, tablet or phone).
- Aged 18-65 years.
- English speakers and ability to read and write in English.
- Availability to participate in 6-8 weeks of this study.
Key exclusion criteria (2 listed)
- If it appears that a different disorder/mental health condition (not PTSD) is primary (e.g. depression, substance use).
- Any other significant disease or disorder which, in the opinion of the investigators, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
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 |
|---|---|---|
| Rumination Intervention for individuals with PTSDThe intervention utilises evidence-based cognitive behavioural therapy (CBT) techniques. | Other | Rumination Invervention - 3 week baseline, Rumination Invervention - 5 week baseline |
Primary outcome
Weekly change of rumination: Response to Intrusion Questionnaire (RIQ; Clohessy & Ehlers, 1999; Murray et al., 2002; Steil & Ehlers, 2000)
Time frame: At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
The RIQ is a 19-item self-report measure which examines responses to intrusive memories. It is divided into three subscales: suppression (6 items), rumination (6-8 items) and dissociation (5 items) which are scored on a scale from 0=never to 3=always. The scales have demonstrated adequate reliability and predictive validity in a range of studies (Beierl et al., 2019; Ehring, Ehlers, et al., 2008; Kleim et al., 2007). The internal consistency of the rumination subscale was between α=.80-.86. For the current study, only the 6-item rumination subscale will be used, in line with the measure recommended on the website of the Oxford Centre for Anxiety Disorder and Trauma (OxCADAT), who developed the measure. For the current study, the "high rumination" inclusion criteria was defined as individuals marking 2 (often) or 3 (always) on any of the 6 items.
6 secondary outcomes
Weekly change of repetitive negative thinking: Repetitive Thinking Questionnaire (RTQ-10; Mahoney et al., 2012; McEvoy et al., 2010)
Time frame: Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Weekly change of time spent ruminating
Time frame: Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Weekly change of PTSD: PTSD Scale for DSM-5 (PCL-5; Blevins et al., 2015)
Time frame: At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Pre-post change of depression: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Time frame: Baseline week 1 and post-intervention week 2 (pre-post measure)
Adherence measure
Time frame: Week 2 post-intervention (end of study)
Feasibility and acceptability measure
Time frame: Week 2 post-intervention (end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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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.
Jennifer Wild, BS MEd DClin principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rumination Intervention for individuals with PTSD in people with Posttraumatic Stress Disorder and Rumination - Thoughts, run by University of Oxford at 2 sites in United Kingdom.
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 10 inclusion and 2 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 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
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?
Weekly change of rumination: Response to Intrusion Questionnaire (RIQ; Clohessy & Ehlers, 1999; Murray et al., 2002; Steil & Ehlers, 2000) (time frame: At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention). 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 4 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.