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Post Traumatic Stress SymptomsNPTSNCT06683027

Nonattachment Training for Post Traumatic Stress Recovery

A study testing Nonattachment for Post Traumatic Stress in people with Post Traumatic Stress Symptoms and PTSD, run by University of Derby at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This pilot study aims to investigate the effectiveness of a novel, co-created intervention based on principles of nonattachment for individuals recovering from Post-Traumatic Stress (PTS). Objectives include: 1. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Post Traumatic Stress Symptoms, PTSD
What is being tested?
Nonattachment for Post Traumatic Stress
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited Kingdom
Study dates
18 Nov 2024to 1 Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Current or recent (within 12 months) diagnosis of PTSD (self-disclosed) OR
  • Participants meeting diagnostic requirements of the ITQ OR
  • Participants meeting diagnostic requirements of the PCL-C
  • Participants willing and able to engage in self-directed course content (self-disclosed)
  • Participants willing and able to engage with contemplative principles and practices (self-disclosed)

Who cannot join

  • Non-English-speaking participants OR participants with a primary residence outside the UK
  • Under the age of 18
  • Participants with comorbidities such as drug or alcohol misuse which could prevent successful intervention engagement
  • Participants diagnosed with a psychotic disorder

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lindsay A Tremblay, MSc contact

321-888-6806

l.tremblay1@unimail.derby.ac.uk

William Van Gordon, Ph.D. contact

+44 (0)7375962731

w.vangordon@derby.ac.uk

United Kingdom1 site
  • University of Derby

    Derby, UK, DE22 1GB

    Lindsay Tremblay, MSc, 321-888-6806, l.tremblay1@unimail.derby.ac.uk

    William Van Gordon, PhD, +44 (0)7375962731, w.vangordon@derby.ac.uk

Other trials in United Kingdom

About this study

Official title: Nonattachment Training for Post Traumatic Stress Recovery: a Pilot Randomised Controlled Trial

This pilot study aims to investigate the effectiveness of a novel, co-created intervention based on principles of nonattachment for individuals recovering from Post-Traumatic Stress (PTS).

Objectives include:

  1. Determine whether participants undertaking nonattachment-based training have higher levels of nonattachment (as indicated by NAS Scale) after completing program.
  2. Determine whether nonattachment levels are impacted after 3 months
  3. Determine whether PTS symptoms are impacted by training/intervention
Read the detailed description

This study will be a pilot randomised controlled trial with an embedded qualitative arm, which will be used to analyse and refine the novel intervention for a second RCT in the future. The study will be registered in a trial registry upon confirmation of ethics approval.

Recruitment will take place primarily through PTSD UK, the organisation that has generously permitted access to social media followers for the co-creation of the intervention itself (Appendix B). Recruitment points will also include Reddit, Facebook, Instagram, and threads/X sites operated by the researcher and their supervisor as well as other relevant groups (permission to post the advert will be sought from the sight admin as appropriate).

Participants will be screened for exclusionary criteria, and then, upon meeting appropriate inclusionary criteria, be prompted to undertake the following baseline assessments:

  • Nonattachment Scale (NAS)- a 30-item Likert scale informed by Buddhist principles measuring aspects such as psychological flexibility, nonreactivity, and capacity for recovery after emotional disturbance.
  • The Acceptance and Action Questionnaire - version II (AAQ-II) - a 7-item Likert scale measuring psychological inflexibility and experiential avoidance.
  • FFMQ- a 39-item Likert scale derived from factor analysis of multiple existing assessments designed to measure mindfulness in daily life.
  • Posttraumatic Stress Disorder Checklist (PCL-5) in which participants are prompted to rate on a 5-point Likert scale how much each of the 20 included problems or complaints.
  • International Trauma Questionnaire (ITQ) - an 18-item Likert scale based on the World Health Organisation's ICD-11 principles for PTSD and CPTSD.

These assessments (except for NAS) were commonly utilised in the systematic review of nonattachment in clinical applications.

Following these assessments, users can access an online version of the NPTS intervention.

Pre-screening will be hosted by Qualtrics for data security, and the course itself will be hosted by Squarespace, a fully GDPR compliant platform, which also permits the researcher access to analytics to ensure participants have actually completed the course content, and to analyse for data related to module popularity and user feedback. There are 8 modules, which can be completed in any order, on the preferred schedule of the user. The user will be informed that they have 8 weeks to complete the program, after which time their data will not be included in the analysis if they have not completed the program. Each module could take as little as 10 minutes, or as long as an hour depending on the pace and depth at which the user chooses to engage with the content. Following the 8-week open access, the user will be thanked for their participation, and will be asked to re-take the assessments taken at baseline to determine intervention impact.

GDPR Compliance and data privacy and protection features of Squarespace can be found here: https://support.squarespace.com/hc/en-us/articles/360000851908-GDPR-and-Squarespace?platform=v6\&websiteId=6703dafa02530b592b6006ba

However, no personal, identifiable participant information will be collected or stored on Squarespace.

Outline of study methods

Procedure:

Invitations to participate (Appendix C) will be advertised on social media platforms designed for groups who are likely to have been exposed to traumatic events or suffering from PTS-type symptoms.

Participants interested in participating will be invited to click on a link taking them to Qualtrics and the following forms:

  1. Participant Information sheet informing them on what their participation entails, including the potential for delayed timing of the training to account for conditions of study design (also contained within Appendix C) ii. Data protection and rights form (Appendix D) iii. Consent form (Appendix E) iv. Demographic and screening questions (Appendix F)

Participants will be asked to acknowledge their reading and understanding of this material.

Participants will be asked for details on their age, country of residence, mental health status, a brief description of any interventions currently being undertaken (e.g., psychotherapy, CBT, EMDR), and gender. Participants will be asked if they are willing and able to engage in self-directed course content, as well as contemplative principles and practices (a brief definition of this will be offered). Participants under the age of 18, having used antipsychotic medications or recreational psychotropics, non-residents of the United Kingdom, not English speaking or diagnosed with a psychotic disorder will be thanked for their time and prevented from proceeding further with the survey. Any data gathered will be excluded from the analysis and purged.

  • Participants proceeding with the study will then be asked to generate an anonymised ID code to facilitate safe handling of data storage and withdrawal.
  • Participants will then be presented with baseline assessments and provided access to Squarespace-hosted NPTS. Participants meeting inclusionary criteria will be directed to a debrief sheet (Appendix G) following the baseline assessments, reminding them of their right to withdraw and the associated process, the controls around the handling of their data, and details for local mental health organisations that they may reach out to for support should their participation have raised any concerns, including:
  • Mind.org.uk - 0300 123 3393 or Email info@mind.org.uk
  • Counselling-directory.org.uk - 0333 325 2500 or via their website
  • Rethink Advice and Information line - 0300 5000 927

Assignment to intervention or control conditions will be set as random logic in Qualtrics.

The control group (group 2) will be on a waitlist and have access to treatment as usual (TAU), ensuring no deception, so all participants can eventually undergo the training. Following a single-blinding procedure, the TAU group will be informed that they will have access to the training (NPTS) after the end of all assessment phases (i.e., which will not take place under research conditions).

The Squarespace-hosted NPTS will remain open for a minimum of 8 weeks, during which participants in the intervention group will receive weekly email prompts reminding them to log in and engage with the content for completion of the course (once a week for 8 weeks, directly from Qualtrics).

At the post intervention 9-week mark, both groups will be prompted to retake the baseline assessments and will receive an email reminder to log in accordingly. Furthermore, a follow up assessment will be scheduled to take place 3-months after then end of the intervention, in which the same measures will be administered to the intervention and control group accordingly.

Following completion of all assessment phases, participants will receive a debrief form (Appendix H) which details the names and contact details of the researcher and supervisor and reminds participants of details for relevant mental health support resources, and thanks them for their participation. Participants will be invited to email the researcher directly should they wish to participate in a brief interview regarding their experience of NPTS. The interview schedule for the qualitative subset can be found in Appendix I. Participants will be informed that interviews will be transcribed to permit analysis for themes and feedback at a later date. This data will help to inform refinements and improvements to the program. The researcher will not video record the interview and the choice of camera on or camera off is entirely theirs.

Materials:

  • Qualtrics
  • Microsoft Teams
  • NAS
  • AAQ-II
  • FFMQ
  • PCL-5
  • ITQ

Planned Analysis:

Within-group effects on PTSD symptoms in the Nonattachment and W/L groups will be examined using two-tailed paired samples t-tests of pre-, post and follow-up intervention scores for all measures, and within group effect sizes (Hedge's g) will be calculated. Between group effects over time will be examined using repeated-measures analyses of variance, and between group effect sizes calculated accordingly. Independent sample t-tests and chi-squared analyses will be used to examine differences between demographics and symptom measures at intake. Data will be analysed on an intention-to-treat basis.

Qualitative data will be transcribed and, through a social constructionist epistemological lens, analysed using thematic analysis following the six-phase approach:

  1. Familiarisation with data
  2. Searching for themes
  3. Reviewing themes
  4. Defining and naming themes
  5. Producing the report
Being tested
Nonattachment for Post Traumatic Stress
Keywords
nonattachment, post traumatic stress, co-creation, NPTS, nonattachment for post traumatic stress, PTSD
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nonattachment for Post Traumatic StressBehavioural

    This study seeks to cultivate nonattachment specifically for the alleviation of symptoms of post-traumatic stress. This is an 8-week online intervention where, following a Qualrics-hosted pre-screen, users are directed to www.npts.online to use as they wish. Users are then solicited to re-take quantitative assessments, and a subset of 10 (target number) will be recruited for a qualitative interview regarding their experience of the intervention.

    A final prompt for assessment re-takes will follow at 3 months post-intervention to determine longitudinal efficacy.

Study groups in NCT06683027
Study groupRoleWhat they receive
Treatment Group 1ExperimentalThis group will receive the first round of access to the program.
Receives: Behavioral: Nonattachment for Post Traumatic Stress
Treatment as UsualActive comparatorThis group will be given access to the program 10 weeks after group 1 so that data from each condition can be compared.
Receives: Behavioral: Nonattachment for Post Traumatic Stress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nonattachment Scale

    This study seeks to understand the impact of the program on levels of nonattachment. Details of the Nonattachment scale (NAS)can be found here: DOI: 10.1080/00223890903425960 NAS is a 30-item Likert scale informed by Buddhist principles measuring aspects such as psychological flexibility, nonreactivity, and capacity for recovery after emotional disturbance. Minimum value is 30 (all answers =1). Maximum value is 180 (all answers = 6). Higher score values are associated with better outcomes.

    Measured: From enrollment to the end of treatment at 8 weeks, and again 3 months later.

Secondary outcomes (1)
  1. Self-reported experiences of Post Traumatic Stress Symptoms using a combination of established trauma-based assessments, and qualitative analysis.

    This study seeks to determine participants' experiences of trauma symptoms after accessing the intervention. The primary metric associated with assessing this outcome will be the Posttraumatic Stress Disorder 5 Checklist (PCL-5; Weathers et al., 2013) in which participants are prompted to rate on a 5-point Likert scale how much each of the 20 included problems or complaints. Higher scores indicate worse outcomes. Minimum values = 0 (20 selections of 0). Maximum values = 80 (20 selections of 4).

    Measured: From enrollment to the end of treatment at 8 weeks, and again 3 months later.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start18 Nov 2024 (estimated)
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
There are two conditions. 1: Experimental group receives access to the online intervention immediately. 2. Treatment as Usual (TAU) group receives delayed (10 weeks) access to the intervention.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06683027
Sponsor's protocol ID
ETH2425-0417
Acronym
NPTS
Status last verified
Nov 2024
First submitted
7 Nov 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Research Ethics Committee of the College of Health, Psychology and Social Care at the University of Derby in accordance with the British Psychological Society (BPS) guidelines for research (2021) has reviewed and approved this study on the condition of participant anonymity. The nature of the qualitative data collected may be particularly sensitive, and there is no need to identify participants for data analysis.

Publications

  • Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.

  • Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.

    PubMed 18310597
  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PubMed 22035996

Questions about this trial

What is this clinical trial studying?

A study testing Nonattachment for Post Traumatic Stress in people with Post Traumatic Stress Symptoms and PTSD, run by University of Derby at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lindsay A Tremblay, MSc (321-888-6806, l.tremblay1@unimail.derby.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nonattachment Scale (time frame: From enrollment to the end of treatment at 8 weeks, and again 3 months later.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06683027, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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