Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series

NCT05625126 | Unknown

• 1 other identifier: 318316
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Posttraumatic Stress Disorder; Rumination - Thoughts

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  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)

  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)

  Baseline week 1 and post-intervention week 2 (pre-post measure)

• Adherence measure

  Week 2 post-intervention (end of study)

Other Outcomes (1)

• Demographic questions

  At screening / pre

Study Arms (2)

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.

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.

Other: Rumination Intervention for individuals with PTSD

Interventions

Rumination Intervention for individuals with PTSD OTHER

The intervention utilises evidence-based cognitive behavioural therapy (CBT) techniques.

Rumination Invervention - 3 week baseline; Rumination Invervention - 5 week baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Health NHS Foundation Trust: collaborator
• Berkshire Healthcare NHS Foundation Trust: collaborator

Study Sites (2)

Talking Therapies, Berkshire Healthcare NHS Foundation Trust

Bracknell, Berkshire, RG12 1QB, United Kingdom

Location

Healthy Minds, Oxford Health NHS Foundation Trust

High Wycombe, HP13 6LA, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jennifer Wild, BS MEd DClin

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple baseline case series

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 22, 2022
• Study Start: December 7, 2022
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

GB (2)