A Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention

August 16, 2023 updated by: KAVrabel, Modum Bad

A Mixed-Methods Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Seventeen clients most female with severe childhood abuse and PTSD and CPTSD participated in the TMC intervention. A mixed-methods design was used. All clients completed questionnaires before (pre) and after (post) the intervention to gain information on symptom change, self-critique, and self-compassion. Second, a qualitative interview addressing clients' experiences of participation, including an explicit focus on adverse experiences, was conducted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Vikersund, Norway, 3371
        • Modum Bad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The inclusion criteria in each group were in accordance with the institution's clinical practice

Description

Inclusion Criteria:

  • report traumatic experiences and trauma related symptoms
  • be between 18 and 65 years of age
  • give informed consent to participate in the study

Exclusion Criteria:

  • acute suicidality
  • serious psychotic symptoms
  • substance abuse interfering with treatment
  • crisis interfering with treatment
  • violent behavior

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: TMC Treatment Approach
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.
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.
Other: TMC Treatment Approach
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PTSD Checklist for Diagnostic Statistical Manual (DSM) -5
Time Frame: Change from pre-treatment to immediately after the intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The International Trauma Questionnaire (ITQ)
Time Frame: Change from pre-treatment to immediately after the intervention
A 17-item self-report measure of ICD-11 PTSD and CPTSD were used to assess the CPTSD symptoms. Clients rated the extent to which they were troubled by CPTSD symptoms in the previous one month period on a 5-point Likert-type scale (0 for "Not at all to 4 for "Extremely"), reflecting the three clusters of disturbances in self-organization (DSO) in CPTSD (affective dysregulation, negative self-concept, and disturbances in relationships).
Change from pre-treatment to immediately after the intervention
Trauma-Related Altered States of Consciousness (TRASC):
Time Frame: Change from pre-treatment to immediately after the intervention
A 10-item self-report measure was used to survey a spectrum of dissociative experiences. Clients rated the extent to which they were troubled by TRASC symptoms on a 5-point Likert-type scale (0 for "Not at all" to 4 for "Extremely"). A total score was calculated across the items 1, 3, 5, 6, and 10 . Two items assessed depersonalization and derealization as in the Dissociative-PTSD subtype and the other items assessed the phenomenology of TRASC more broadly in reference to the subjective dimensions of time, thought, body, and emotion as per the 4-D model of trauma-related dissociation
Change from pre-treatment to immediately after the intervention
General Anxiety Disorder-7 (GAD-7)
Time Frame: Change from pre-treatment to immediately after the intervention
This symptom assessment tool measures anxiety with seven items in GAD-7 on a 4-point scale that assesses the impact on daily life.
Change from pre-treatment to immediately after the intervention
Patient Health Questionnaire-9 (PHQ 9)
Time Frame: Change from pre-treatment to immediately after the intervention
This symptom assessment tool measures depression with nine items in PHQ-9 on a 4-point scale that assesses the impact on daily life.
Change from pre-treatment to immediately after the intervention
Self-Compassion Scale (SCS)
Time Frame: Change from pre-treatment to immediately after the intervention
The 26-item SCS consists of three positive subscales, namely Self-Kindness (5 items), Common Humanity (4 items), and Mindfulness (4 items) and three negative subscales, namely Self-Judgment (5 items), Isolation (4 items), and Over-Identification (4 items). Respondents rate their agreement with items on a 5-point Likert-type scale from "Almost always" (5) to "Almost never" (1).
Change from pre-treatment to immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Modum Bad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Trauma Outpatient Unit

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

It is already available at a secure server at modum bad. Hopefully, it will be published within next fall, 2023

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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