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

Complex Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05993468
• Other study ID #: Trauma Outpatient Unit
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: August 2023
• Source: Modum Bad
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Adverse experiences of participation are also explored explicitly.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Norway	Modum Bad	Vikersund

Sponsors (1)

Lead Sponsor	Collaborator
Modum Bad

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Change from pre-treatment to immediately after the intervention
Secondary	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	Change from pre-treatment to immediately after the intervention
Secondary	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.	Change from pre-treatment to immediately after the intervention
Secondary	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.	Change from pre-treatment to immediately after the intervention
Secondary	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).	Change from pre-treatment to immediately after the intervention