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

NCT ID: NCT05625126

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2023-06-30

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.

Conditions

Posttraumatic Stress Disorder; Rumination - Thoughts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rumination Intervention for individuals with PTSD

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Rumination Intervention for individuals with PTSD

Intervention Type: OTHER

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

Interventions

Rumination Intervention for individuals with PTSD

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford Health NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Berkshire Healthcare NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Wild, BS MEd DClin

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Talking Therapies, Berkshire Healthcare NHS Foundation Trust

Bracknell, Berkshire, United Kingdom

Healthy Minds, Oxford Health NHS Foundation Trust

High Wycombe, , United Kingdom

Countries

United Kingdom

Other Identifiers

318316

Identifier Type: -

Identifier Source: org_study_id