NCT06683027

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 7, 2024

Last Update Submit

November 8, 2024

Conditions

Keywords

nonattachmentpost traumatic stressco-creationNPTSnonattachment for post traumatic stressPTSD

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Self-reported experiences of Post Traumatic Stress Symptoms using a combination of established trauma-based assessments, and qualitative analysis.

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

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

This group will receive the first round of access to the program.

Behavioral: Nonattachment for Post Traumatic Stress

Treatment as Usual

ACTIVE COMPARATOR

This group will be given access to the program 10 weeks after group 1 so that data from each condition can be compared.

Behavioral: Nonattachment for Post Traumatic Stress

Interventions

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.

Treatment Group 1Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Derby

Derby, UK, DE22 1GB, United Kingdom

Location

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    PMID: 18310597BACKGROUND
  • 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.

    PMID: 22035996BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • William Van Gordon, PhD

    University of Derby

    STUDY CHAIR

Central Study Contacts

Lindsay A Tremblay, MSc

CONTACT

William Van Gordon, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 12, 2024

Study Start

November 18, 2024

Primary Completion

January 31, 2025

Study Completion

March 1, 2025

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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.

Locations