Clinical trial NCT05625126: Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series
Official title: Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Rumination - Thoughts
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford Health NHS Foundation Trust
name: Berkshire Healthcare NHS Foundation Trust
First posted: 2022-11-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Multiple baseline case series
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weekly change of rumination: Response to Intrusion Questionnaire (RIQ; Clohessy & Ehlers, 1999; Murray et al., 2002; Steil & Ehlers, 2000)
timeFrame: 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:
measure: Weekly change of repetitive negative thinking: Repetitive Thinking Questionnaire (RTQ-10; Mahoney et al., 2012; McEvoy et al., 2010)
timeFrame: Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
measure: Weekly change of time spent ruminating
timeFrame: Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
measure: Weekly change of PTSD: PTSD Scale for DSM-5 (PCL-5; Blevins et al., 2015)
timeFrame: At screening, baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
measure: Pre-post change of depression: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
timeFrame: Baseline week 1 and post-intervention week 2 (pre-post measure)
measure: Adherence measure
timeFrame: Week 2 post-intervention (end of study)
measure: Feasibility and acceptability measure
timeFrame: Week 2 post-intervention (end of study)
Other outcomes:
measure: Demographic questions
timeFrame: At screening / pre
Locations:
city: Bracknell
country: United Kingdom
facility: Talking Therapies, Berkshire Healthcare NHS Foundation Trust
state: Berkshire
city: High Wycombe
country: United Kingdom
facility: Healthy Minds, Oxford Health NHS Foundation Trust
Study officials:
affiliation: University of Oxford
name: Jennifer Wild, BS MEd DClin
role: PRINCIPAL_INVESTIGATOR
References: