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

Sponsor
Modum Bad (Other)
Overall Status
Completed
CT.gov ID
NCT05993468
Collaborator
(none)
17
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49.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: TMC Treatment Approach

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

Study Type:
Observational
Actual Enrollment :
17 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Mixed-Methods Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. 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

  3. 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.

  4. 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.

  5. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Modum Bad Vikersund Norway 3371

Sponsors and Collaborators

  • Modum Bad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
KAVrabel, Research director, Modum Bad
ClinicalTrials.gov Identifier:
NCT05993468
Other Study ID Numbers:
  • Trauma Outpatient Unit
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by KAVrabel, Research director, Modum Bad
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023