A Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
A Mixed-Methods Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
1 other identifier
observational
17
1 country
1
Brief Summary
This mixed-methods pilot study aim to assess the changes in symptoms of post-traumatic stress disorder (PTSD), complex post-traumatic stress disorder (CPTSD), dissociative symptoms, self-critique, and self-compassion following participation in a 16-week trauma-sensitive mindfulness and compassion (TMC) intervention. Adverse experiences of participation are also explored explicitly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedAugust 21, 2023
August 1, 2023
1 year
June 26, 2023
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD Checklist for Diagnostic Statistical Manual (DSM) -5
The Posttraumatic checklist (PCL-5) is a measure of perceived PTSD symptom severity in the past month. It was used to assess the likelihood of a PTSD diagnosis given 20 symptom descriptions (items) reflecting the DSM-5 criteria. Clients rated the extent to which they were troubled by PTSD symptoms on a 5-point Likert-type scale (0 for "Not at all" to 4 for "Extremely").
Change from pre-treatment to immediately after the intervention
Secondary Outcomes (5)
The International Trauma Questionnaire (ITQ)
Change from pre-treatment to immediately after the intervention
Trauma-Related Altered States of Consciousness (TRASC):
Change from pre-treatment to immediately after the intervention
General Anxiety Disorder-7 (GAD-7)
Change from pre-treatment to immediately after the intervention
Patient Health Questionnaire-9 (PHQ 9)
Change from pre-treatment to immediately after the intervention
Self-Compassion Scale (SCS)
Change from pre-treatment to immediately after the intervention
Study Arms (2)
TMC - group 1
TMC - group 1 was a closed group treated at a specialized outpatient facility for adult clients with CPTSD and complex dissociative disorders. Group 1 was led by two clinical psychologists
TMC - group 2
TMC - group 2 was connected to specialized mental health services, but the intervention itself was carried out at a community centre. The community centre has collaborated with the District Psychiatric Centre (DPS) for many years, hosting an TMC group open to anyone attending the community centre in addition to clients connected to the DPS. This open concept was continued through the study intervention, but only clients connected to the DPS were included in the study.
Interventions
The TMC approach consists of 16 weekly group sessions, each lasting 2 hours. The first 10 sessions focus mainly on building mindfulness capacities, and the last 6 sessions on developing compassion toward self and others. Between sessions, participants are encouraged to do exercises with the support of audio files. The approach was developed with a transdiagnostic perspective, including clients with a variety of trauma-related symptoms.
Eligibility Criteria
The inclusion criteria in each group were in accordance with the institution's clinical practice
You may qualify if:
- report traumatic experiences and trauma related symptoms
- be between 18 and 65 years of age
- give informed consent to participate in the study
You may not qualify if:
- acute suicidality
- serious psychotic symptoms
- substance abuse interfering with treatment
- crisis interfering with treatment
- violent behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Modum Badlead
Study Sites (1)
Modum Bad
Vikersund, 3371, Norway
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research director
Study Record Dates
First Submitted
June 26, 2023
First Posted
August 15, 2023
Study Start
January 1, 2019
Primary Completion
January 1, 2020
Study Completion
March 1, 2023
Last Updated
August 21, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- It is already available at a secure server at modum bad. Hopefully, it will be published within next fall, 2023
- Access Criteria
- Placing the results of studies in a broader context: (for example, meta-analysis) Using the data as a convenience sample to address issues different from our research objectives Collaborating directly with other researchers where data need to be transferred to an alternative location for planned analyses connection of individual outcomes
The ethical approval granted by the Regional Committees for Medical and Health Research Ethics in Norway (REK and NSD) and in accordance with the information given to the participants in the informed consent form regarding the use of data, does not allow the authors to submit the data to a public repository. In line with the ethics approval, the data are to be kept at a secure server only accessible by the authors of this study. Access to the data can be granted following ethical approval of suggested project plan for the use of data from Modum Bad. The data will then be anonymized and further stored at a secure system. Such requests are to be sent to research leader, KariAnne Vrabel, Modum Bad, email: karianne.vrabel@modum-bad.no.