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

Completed

• Conditions: Complex Post-Traumatic Stress Disorder

• Registration Number: NCT05993468
• Lead Sponsor: Modum Bad

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.

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2023-03-01
• Study First Submitted: 2023-06-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-15
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for Diagnostic Statistical Manual (DSM) -5	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").

Secondary Outcome Measures

Name	Time	Method
The International Trauma Questionnaire (ITQ)	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).
Trauma-Related Altered States of Consciousness (TRASC):	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
Patient Health Questionnaire-9 (PHQ 9)	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.
General Anxiety Disorder-7 (GAD-7)	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.
Self-Compassion Scale (SCS)	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).

Trial Locations

Locations (1)

Modum Bad; 🇳🇴 Vikersund, Norway