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Completed

NCT Number: NCT05993468

A 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.

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Key information

Conditions

Complex Post-Traumatic Stress Disorder Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Modum Bad

Vikersund, 3371, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMC Treatment Approach

Other

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.

Primary outcomes

  1. 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").

Secondary outcomes

  1. 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).

  2. 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

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Aug 15, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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