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

Primary Purpose

Posttraumatic Stress Disorder, Rumination - Thoughts

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Rumination Intervention for individuals with PTSD
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Talking Therapies, Berkshire Healthcare NHS Foundation Trust
  • Healthy Minds, Oxford Health NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rumination Invervention - 3 week baseline

Rumination Invervention - 5 week baseline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Weekly change of time spent ruminating
One-item question assessing time spent ruminating per week (estimated hours/minutes)
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.
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.
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).
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".

Full Information

First Posted
November 2, 2022
Last Updated
April 3, 2023
Sponsor
University of Oxford
Collaborators
Oxford Health NHS Foundation Trust, Berkshire Healthcare NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05625126
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford Health NHS Foundation Trust, Berkshire Healthcare NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Rumination - Thoughts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple baseline case series
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rumination Invervention - 3 week baseline
Arm Type
Experimental
Arm Description
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.
Arm Title
Rumination Invervention - 5 week baseline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rumination Intervention for individuals with PTSD
Intervention Description
The intervention utilises evidence-based cognitive behavioural therapy (CBT) techniques.
Primary Outcome Measure Information:
Title
Weekly change of rumination: Response to Intrusion Questionnaire (RIQ; Clohessy & Ehlers, 1999; Murray et al., 2002; Steil & Ehlers, 2000)
Description
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.
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
Secondary Outcome Measure Information:
Title
Weekly change of repetitive negative thinking: Repetitive Thinking Questionnaire (RTQ-10; Mahoney et al., 2012; McEvoy et al., 2010)
Description
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.
Time Frame
Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Title
Weekly change of time spent ruminating
Description
One-item question assessing time spent ruminating per week (estimated hours/minutes)
Time Frame
Baseline weeks 1, 2, 3, (weeks 4 & 5 for participants in 5-week baseline arm), and weeks 1 & 2 post intervention
Title
Weekly change of PTSD: PTSD Scale for DSM-5 (PCL-5; Blevins et al., 2015)
Description
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.
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
Title
Pre-post change of depression: Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Description
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.
Time Frame
Baseline week 1 and post-intervention week 2 (pre-post measure)
Title
Adherence measure
Description
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).
Time Frame
Week 2 post-intervention (end of study)
Title
Feasibility and acceptability measure
Description
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".
Time Frame
Week 2 post-intervention (end of study)
Other Pre-specified Outcome Measures:
Title
Demographic questions
Description
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.
Time Frame
At screening / pre

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Wild, BS MEd DClin
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Talking Therapies, Berkshire Healthcare NHS Foundation Trust
City
Bracknell
State/Province
Berkshire
ZIP/Postal Code
RG12 1QB
Country
United Kingdom
Facility Name
Healthy Minds, Oxford Health NHS Foundation Trust
City
High Wycombe
ZIP/Postal Code
HP13 6LA
Country
United Kingdom

12. IPD Sharing Statement

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

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