Complex Post-Traumatic Stress DisorderNCT05993468
A Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
An observational study of Complex Post-Traumatic Stress Disorder, run by Modum Bad at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder
- What is being tested?
- TMC Treatment Approach
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2019to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The inclusion criteria in each group were in accordance with the institution's clinical practice
Who may be able to join
- report traumatic experiences and trauma related symptoms
- be between 18 and 65 years of age
- give informed consent to participate in the study
Who cannot join
- acute suicidality
- serious psychotic symptoms
- substance abuse interfering with treatment
- crisis interfering with treatment
- violent behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Complex Post-Traumatic Stress Disorder
- Being tested
- TMC Treatment Approach
- Keywords
- mindfullness, treatment, compassion, trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC Treatment ApproachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: TMC Treatment Approach | |
| 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. Receives: Other: TMC Treatment Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Change from pre-treatment to immediately after the intervention
Secondary outcomes (5)
The International Trauma Questionnaire (ITQ)
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).
Measured: Change from pre-treatment to immediately after the intervention
Trauma-Related Altered States of Consciousness (TRASC):
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
Measured: Change from pre-treatment to immediately after the intervention
General Anxiety Disorder-7 (GAD-7)
This symptom assessment tool measures anxiety with seven items in GAD-7 on a 4-point scale that assesses the impact on daily life.
Measured: Change from pre-treatment to immediately after the intervention
Patient Health Questionnaire-9 (PHQ 9)
This symptom assessment tool measures depression with nine items in PHQ-9 on a 4-point scale that assesses the impact on daily life.
Measured: Change from pre-treatment to immediately after the intervention
Self-Compassion Scale (SCS)
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).
Measured: Change from pre-treatment to immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KAVrabel, Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993468
- Sponsor's protocol ID
- Trauma Outpatient Unit
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-Methods Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
- ClinicalTrials.gov ID
- NCT05993468
- Acronym / sponsor ID
- Trauma Outpatient Unit
- Conditions
- Complex Post-Traumatic Stress Disorder
- Keywords
- mindfullness, treatment, compassion, trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMC - group 1 | – | Other: TMC Treatment ApproachTMC - 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 | – | Other: TMC Treatment ApproachTMC - 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion criteria in each group were in accordance with the institution's clinical practice
Key inclusion criteria (3 listed)
- report traumatic experiences and trauma related symptoms
- be between 18 and 65 years of age
- give informed consent to participate in the study
Key exclusion criteria (5 listed)
- acute suicidality
- serious psychotic symptoms
- substance abuse interfering with treatment
- crisis interfering with treatment
- violent behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMC Treatment ApproachThe 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. | Other | TMC - group 1, TMC - group 2 |
Primary outcome
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").
5 secondary outcomes
The International Trauma Questionnaire (ITQ)
Time frame: 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
General Anxiety Disorder-7 (GAD-7)
Time frame: 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
Self-Compassion Scale (SCS)
Time frame: Change from pre-treatment to immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Complex Post-Traumatic Stress Disorder
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
Recruiting
Psychological Prehabilitation for Complex Gastrointestinal Surgery
Post-traumatic Stress Symptoms, Anxiety
Not yet recruiting
RECONNECT - Treatments for Complex PTSD
Complex Post-Traumatic Stress Disorder (CPTSD)
Active, not recruitingObservational study
Using Data Science To Center Patient Perspectives in Mechanism Discovery
Posttraumatic Stress Disorder, Complex Post-Traumatic Stress Disorder
RecruitingObservational study
Attachment and Post-Traumatic Stress Disorder in Military Personnel: Characterization of the French Military Population, Exploration of Biopsychosocial Factors, and Study of the Impact of Security Priming on Emotional Contagion Capacities
Post-traumatic Stress Disorder (PTSD), Emotional Contagion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Post-Traumatic Stress Disorder, run by Modum Bad at 1 site in Norway.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 21 Aug 2023. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for Diagnostic Statistical Manual (DSM) -5 (time frame: Change from pre-treatment to immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.