Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD

NCT02755103 | Completed Results DMC

• 2 other identifiers: Pro00048115R01DA040968
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will modify an already existing therapy for individuals with substance use disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance use disorders (SUD) treatment who suffer with both PTSD and SUD. Mindfulness meditation has been shown to help individuals to cope with stress and regulate emotions. Through meditation practice women will experience less distress related to PTSD symptoms and reduced substance use in response to emotional triggers. Women enrolled in intensive SUD treatment at a community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone. The MBRP group sessions will replace 90 minutes of TAU group therapy. Measures of feasibility of implementation, acceptance and adherence will be obtained. Preliminary efficacy for substance use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months' follow-up.

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Keywords

Mindfulness; Comorbid PTSD and SUD; Meditation

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5

  The Clinician-Administered Post Traumatic Stress Disorder Scale fifth edition (CAPS-5) is a 20 item structured interview that assesses the frequency and severity of Post Traumatic Stress Disorder (PTSD) symptoms on a scale of 0 (absent) to 4 (extreme/incapacitating). Scores are summed for a total score and higher scores represent higher symptom severity. Score range is 0-80.

  8 weeks (60 days baseline to end of treatment). Missing scores were imputed. Scores presented are controlled for baseline scores.

Secondary Outcomes (14)

• Clinician Administered Posttraumatic Stress Disorder Scale-5 (CAPS-5)

  3 (90 days from end of treatment to 3 month follow-up) and 6 (90 days from 3 month follow-up to 6 month follow-up) month follow-up. Missing scores are imputed. Scores presented are controlled for baseline scores.

• Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR)

  weekly during treatment, end of treatment 8 weeks, 3 and 6 month follow-up. Missing scores were imputed at different time periods. Scores presented are controlled for baseline scores.

• Time Line Follow Back (TLFB)

  8 weeks (60 days from baseline to end of treatment).

• Time Line Follow Back (TLFB)

  3 month follow-up mean percent days using alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended (n=53) and reported any use at the 3 month follow-up (90 days from 3 to 6 month) visit.

• Time Line Follow Back (TLFB)

  6 month follow-up mean percent days using alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended (n=52) and reported any use at the 6 month follow-up (90 days from 3 to 6 month follow-up) visit.

Study Arms (2)

Women receiving MBRP plus TAU

EXPERIMENTAL

Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group).

Behavioral: Mindfulness Based Relapse Prevention (MBRP)

Women receiving TAU

NO INTERVENTION

Women will only receive treatment as usual (TAU less trauma focused group).

Interventions

Mindfulness Based Relapse Prevention (MBRP) BEHAVIORAL

MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses.

Women receiving MBRP plus TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between 18 and 65 years of age enrolled in the Charleston Center (CC) intensive outpatient and New Life program treatment.
• Able to comprehend English.
• Meets fifth edition Diagnostic and Statistical Manual V (DSM V) criteria for current alcohol or substance use disorder and have used alcohol/substances in the 30 days prior to clinic treatment entry.
• Meets DSM V criteria for current PTSD with a score greater than or equal to 25 on the CAPS 5.0.
• Participants may also meet criteria for a mood or anxiety disorder. Participants on psychotropic medications for a mood or anxiety disorder must have been stabilized on medications for at least 4 weeks before therapy initiation.
• Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• Willing to commit to 8 therapy sessions, baseline, weekly and follow-up assessments.

You may not qualify if:

• Current primary psychotic or thought disorder (i.e. Schizophrenia or schizoaffective disorder, mania), major depression with suicidal ideation, dissociative identity disorder and/or homicidal ideations.
• Present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study.
• In ongoing therapy for PTSD either within or outside of the CC, who are not willing to discontinue these therapies for the duration of the study therapy,
• Unstable medical condition or one that may require hospitalization during the course of the study.
• Women who are pregnant or planning to become pregnant.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Charleston Center

Charleston, South Carolina, 29401, United States

Location

Related Publications (1)

• Killeen TK, Wen CC, Neelon B, Baker N. Predictors of Treatment Completion among Women Receiving Integrated Treatment for Comorbid Posttraumatic Stress and Substance Use Disorders. Subst Use Misuse. 2023;58(4):500-511. doi: 10.1080/10826084.2023.2170183. Epub 2023 Jan 27.

  PMID: 36705433 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Therese K Killeen PhD, Principal Investigator
• Organization: Medical University of South Carolina

killeent@musc.edu

843-792-5232

Study Officials

• Therese K Killeen, PhD APRN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 28, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 3, 2023
• Results First Posted: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)