- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05625126
Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hjördis S Lorenz, BA PhD
- Phone Number: 01865 225145
- Email: hjordis.lorenz@psy.ox.ac.uk
Study Contact Backup
- Name: Jennifer Wild, BS MEd DClin
- Phone Number: 01865 225145
- Email: jennifer.wild@psy.ox.ac.uk
Study Locations
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High Wycombe, United Kingdom, HP13 6LA
- Healthy Minds, Oxford Health NHS Foundation Trust
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Berkshire
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Bracknell, Berkshire, United Kingdom, RG12 1QB
- Talking Therapies, Berkshire Healthcare NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rumination Invervention - 3 week baseline
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. |
The intervention utilises evidence-based cognitive behavioural therapy (CBT) techniques.
|
Experimental: Rumination Invervention - 5 week baseline
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. |
The intervention utilises evidence-based cognitive behavioural therapy (CBT) techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
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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
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One-item question assessing time spent ruminating per week (estimated hours/minutes)
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Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
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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
|
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.
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At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
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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)
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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.
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Baseline week 1 and post-intervention week 2 (pre-post measure)
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Adherence measure
Time Frame: Week 2 post-intervention (end of study)
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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).
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Week 2 post-intervention (end of study)
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Feasibility and acceptability measure
Time Frame: Week 2 post-intervention (end of study)
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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".
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Week 2 post-intervention (end of study)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic questions
Time Frame: At screening / pre
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Demographic questions relating to age, gender, ethnicity, time spent on waitlist, previous mental health diagnoses, and previous PTSD treatment.
Ethnicity will be collected in line with guidance by the National Institute for Health and Care Research (NIHR, 2020) to include underserved and minority groups in research.
By collecting data on ethnicity, research can later reflect on whether underserved and minority groups were included and, if applicable, highlight limitations of the research.
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At screening / pre
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Wild, BS MEd DClin, University of Oxford
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 318316
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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