Creating Change

3  — Promising Research Evidence
Medium
3  — Promising Research Evidence
Medium

About This Program

Target Population: Adults ages 18 and above who have experienced trauma and addiction

Program Overview

Creating Change is a past-focused model for trauma and addiction for a very broad range of clients. It can be conducted in individual or group format by any provider. The program is designed to be highly accessible, flexible, and engaging from a public health standpoint. Each treatment topic helps clients face their past by addressing a theme such as:

  • Honor Your Survival
  • Break the Silence
  • Understand Memory
  • Identify Influences (Family, Community, Culture)
  • Knowing and Not Knowing
  • Balance Dark and Light
  • What You Want People to Understand

Creating Change has the same format and compassionate tone as Seeking Safety (a present-focused model for trauma and/or addiction) and can be used with that model if desired.

Program Goals

The goals of Creating Change are:

  • Reduce trauma symptoms.
  • Reduce substance use or other addictive behavior.
  • Reduce other mental health symptoms (e.g., depression).
  • Increase functioning (e.g., work, social).
  • Increase self-compassion.

Logic Model

The program representative did not provide information about a Logic Model for Creating Change.

Essential Components

The essential components of Creating Change include:

  • Individual or group intervention
  • Flexible delivery:
    • Topics can be done in any order and, if the goal is to mirror the clinical trial method, clients should be offered all topics.
    • Session length and pacing can vary based on the setting.
  • Integrated treatment: Addresses trauma and addiction at the same time
  • Seven key principles:
    • A goal of lasting change—By facing the past, clients can achieve sustainable recovery.
      • Public health relevance—
        • Flexible
        • Low cost
        • Designed for a broad range of clients who have experienced trauma and addiction
        • Designed for a broad range of providers
      • Skill development—Teaching clients how to process painful life events so they can continue to do so on their own
      • Inspiration—The use of quotations and poignant language to help build hope and convey the message that clients can succeed
      • Balancing positive and negative life experiences—Encouraging clients to integrate the full range of their experiences, both what was difficult and what allowed them to survive
      • Safeguards—Emphasis on best practices when working with trauma and/or addiction:
        • Explicit strategies to ensure safety
        • Letting clients set the pace in what they share
      • Convergence with Seeking Safety—Has the same format and compassionate tone as Seeking Safety and can be used with that model if desired. Seeking Safety (www.seekingsafety.org) is a present-focused model for trauma and/or addiction.
    • Numerous treatment topics, each with a clinician guide and client handouts. Examples of topics are:
      • Create Change
      • Reassurance
      • Honor your survival
      • Break the silence
      • Identify influences (family, community, culture)
      • Understand memory
      • Untangle the web of trauma and addiction
      • Notice survival patterns
      • Shift perspective
      • Knowing and Not Knowing
      • Heal your relationship with your body
      • What you want people to understand Imagine a conversation
      • Explore a reminder of the past
      • Balance dark and light

Program Delivery

Adult Services

Creating Change directly provides services to adults (regardless of whether they are parents or caregivers) and addresses the following:

  • Trauma symptoms and substance abuse (or other addiction) symptoms

Recommended Intensity:

Session length and pacing are flexible to adapt to the setting. An individual session might be 50-60 minutes and a group 60-90 minutes or whatever length is typically done. Sessions can be weekly, twice-weekly, or any other pacing.

Recommended Duration:

Duration is flexible as long as all topics are offered in the course offering, but 12 sessions or more is suggested.

Delivery Settings

This program is typically conducted in a(n):

  • Community Daily Living Setting
  • Hospital
  • Outpatient Clinic
  • Group or Residential Care
  • Justice Setting (Juvenile Detention, Jail, Prison, Courtroom, etc.)
  • School Setting (Including: Day Care, Day Treatment Programs, etc.)
  • Shelter (Domestic Violence, Homeless, etc.)
  • Virtual (Online, Telephone, Video, Zoom, etc.)

Homework

Creating Change includes a homework component:

There is optional homework that is chosen by the recipient.

Resources Needed to Run Program

The typical resources for implementing the program are:

No special equipment needed.

Manuals and Training

Prerequisite/Minimum Provider Qualifications

Any provider can conduct Creating Change and/or obtain training on it, regardless of degree, licensure, etc.

Manual Information

There is a manual that describes how to deliver this program.

Program Manual(s)

Najavits, L. M. (in press). Creating Change: A past-focused model for trauma and/or addiction. Guilford Press.

The book is coming out in 2022 and, in the meantime, people can contact the program contact (see bottom of page) for information or a prepublication sample

Training Information

There is training available for this program.

Training Contact:
Training Type/Location:

Training occurs in whatever form is best for the agency and can include webinars, onsite, phone consultation, or a combination. Training is optional unless a research study is being conducted.

Number of days/hours:

The typical training is 1 day for providers. For fidelity and supervisor training, this is typically done via phone consultation and varies in length as it is a structured plan using work samples or role-plays for the staff person to demonstrate competence.

Implementation Information

Pre-Implementation Materials

There are no pre-implementation materials to measure organizational or provider readiness for Creating Change.

Formal Support for Implementation

There is formal support available for implementation of Creating Change as listed below:

Treatment Innovations provides implementation assistance for Creating Change in the form of:

  • Fidelity monitoring and training of implementing agency personnel to conduct fidelity monitoring
  • Implementation phone consultation to help an agency with support and coaching for conducting Creating Change
  • Program evaluation (e.g., design and consultation services for studies of Creating Change at all levels, including randomized controlled trials, pilot studies, quality assurance, etc.)
  • Supervisor development to help supervisors provide feedback to their staff who are implementing Creating Change

The format for the consultations above is typically by phone (but can be onsite or via webinar). It is available ongoing for as long as an agency would like. For the fidelity and supervisor components listed above, there is a structured plan using work samples or role-plays for the staff person to demonstrate competence to receive a certificate.

Fidelity Measures

There are fidelity measures for Creating Change as listed below:

The Creating Change Fidelity Scale can be completed by an observer or used as a self-assessment. Training on it is optional, unless a research study is being conducted on Creating Change, in which case training on the scale and use of it during the research gathering timeframe is required (contact the training contact above for more information on that). The measure is publicly available at: https://www.treatment-innovations.org/uploads/2/5/5/5/25555853/creating_chg_adher_scale_10-21-2010_adherence_scale_for_creating_change.doc

Implementation Guides or Manuals

There are no implementation guides or manuals for Creating Change.

Implementation Cost

There are no studies of the costs of Creating Change.

Research on How to Implement the Program

Research has not been conducted on how to implement Creating Change.

Relevant Published, Peer-Reviewed Research

Child Welfare Outcome: Child/Family Well-Being

Najavits, L. M., Krinsley, K., Waring, M. E., Gallagher, M. W., & Skidmore, W. (2018). A randomized controlled trial for veterans with PTSD and substance use disorder: Creating Change versus Seeking Safety. Substance Use and Misuse, 53(11), 1788-1800. https://doi.org/10.1080/10826084.2018.1432653

Type of Study: Randomized controlled trial
Number of Participants: 52

Population:

  • Age — Mean=48.75 years
  • Race/Ethnicity — 60% Caucasian/non-Hispanic, 30.1% African American, 4.0% Hispanic, 3.9% Mixed race, and 2.0% Pacific Islander
  • Gender — 73% Male
  • Status — Participants were veterans with posttraumatic stress disorder (PTSD) and substance use disorders.

Location/Institution: Not specified

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of this study was to compare a new past-focused treatment (Creating Change; CC), to a present-focused treatment for PTSD/SUD (Seeking Safety; SS), on symptoms of both disorders. Participants were randomized (n = 26 per treatment) into two groups and assessed at baseline, end-of-treatment, and 3-month follow-up. In this study, there were 17 weekly 1-hour individual sessions. Measures utilized include the Mini Neuoropsychiatric Interview, the Addiction Severity Index-Lite (ASI), the Beliefs about Substance Use, a Nicotine Screen, the Trauma Related Guilt Inventory, the World Assumptions Scale, the Coping Self-Efficacy Scale, the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, the General Self-Efficacy Scale, the Global Severity Index of the Brief Symptom Inventory, the Clinical Global Impressions Scale-Patient version, the Structured Clinical Interview for DSM-IV Personality Disorders, the Suicidal Behaviors Questionnaire, the Client Satisfaction Questionnaire and the Helping Alliance Scale. Results indicated that both conditions improved over time, with no difference between conditions, on PTSD, alcohol use, and drug use (the primary outcomes) as well as mental health symptoms, quality of life, self-efficacy, and SUD cognitions. Effect sizes were medium except for alcohol use, which was large. Change over time reflected improvement from baseline to end-of-treatment, with gains sustained at follow-up, although alcohol use showed continued improvement from end-of-treatment to follow-up. Both treatments evidenced a strong safety profile; and attendance, alliance, and treatment satisfaction were also very strong.). Effect sizes were consistently large, including for both alcohol and drug problems. No adverse events were reported. Limitations include small sample size, did not have a solely treatment-as-usual or no-treatment control arm in this study, and length of follow-up.

Length of postintervention follow-up: 3 months.

The following studies were not included in rating Creating Change on the Scientific Rating Scale...

Najavits, L. M., Schmitz, M., Gotthardt, S., & Weiss, R. D. (2005). Seeking Safety plus exposure therapy: An outcome study on dual diagnosis men. Journal of Psychoactive Drugs, 37(4), 425–435. https://doi.org/10.1080/02791072.2005.10399816

The purpose of this study was to examine Creating Change with men with posttraumatic stress disorder (PTSD) and substance use disorder (SUD). Measures utilized include the Structured Clinical Interview for DSM-IV, the Trauma History Questionnaire, the Addiction Severity Index-Fifth Edition, the Trauma Symptom Checklist‐40 (TSC‐40), the Brief Symptom Inventory (BSI), the Suicidal Behaviors Questionnaire (SBQ), the Social Adjustment Scale, the Global Assessment of Functioning scale, the World Assumptions Scale, the Patient Preference Questionnaire, the Helping Alliance Questionnaire II, the Client Satisfaction Questionnaire, the Seeking Safety Feedback Questionnaire, and the Exposure Therapy Revised-Feedback Questionnaire. Results indicated significant improvements in drug use, family/social functioning, trauma symptoms, anxiety, disassociation, sexuality, hostility, overall functioning, meaningfulness, and feelings and thoughts related to safety. Trends indicating improvement on 11 other outcome variables were also found. Treatment attendance, satisfaction, and alliance were extremely high. Limitations include small sample size, lack of control condition, and no follow-up. Note: Since this study did not use a control condition, this article was not used in the rating/review process.

Najavits, L. M., & Johnson, K. M. (2014). Pilot study of Creating Change, a new past-focused model for PTSD and substance abuse. The American Journal on Addictions, 23(5), 415–422. https://doi.org/10.1111/j.1521-0391.2014.12127.x

The purpose of this study was to examine Creating Change with men and women outpatients diagnosed with posttraumatic stress disorder (PTSD) and substance use disorder (SUD). Measures utilized include the Substance Use Disorder/PTSD Timeline, the Addiction Severity Index (ASI25), the Beliefs about Substance Abuse Scale (BSAS), the Treatment Services Review (TSR), the Trauma History Questionnaire (THQ), the PTSD Checklist—Civilian Version (PCL), the Trauma Symptom Checklist‐40 (TSC‐40), the World Assumptions Scale (WAS), the Mini‐International Neuropsychiatric Interview (MINI), the Behavior and Symptom Identification Scale (BASIS‐32), the Brief Symptom Inventory (BSI), the Coping Strategies Inventory (CSI), the New‐Buss Aggression Questionnaire, the Suicidal Behaviors Questionnaire (SBQ), the Clinical Global Improvement Scale, the Helping Alliance Questionnaire (HAQ), the Client Satisfaction Questionnaire (CSQ), and the End‐of‐Session and the Creating Change End‐of‐Treatment Questionnaire. Results indicated significant improvements were found in multiple domains including some PTSD and trauma‐related symptoms (e.g., dissociation, anxiety, depression, and sexual problems); broader psychopathology (e.g., paranoia, psychotic symptoms, obsessive symptoms, and interpersonal sensitivity); daily life functioning; cognitions related to PTSD; coping strategies; and suicidal ideation (altogether 19 variables, far exceeding the rate expected by chance). Effect sizes were consistently large, including for both alcohol and drug problems. No adverse events were reported. Limitations include small sample size, lack of control condition, and no follow-up. Note: Since this study did not use a control condition, this article was not used in the rating/review process.

Additional References

Najavits, L. M. (2014). Creating Change: A new past-focused model for PTSD and substance abuse. In P. Ouimette & J. P. Read (Eds.), Trauma and substance abuse: Causes, consequences, and treatment of comorbid disorders (pp. 281–303). American Psychological Association Press. https://doi.org/10.1037/14273-014 and https://www.treatment-innovations.org/uploads/2/5/5/5/25555853/2013_creating_change_in_ouimette_book.pdf

Contact Information

Jamie Miller
Agency/Affiliation: Treatment Innovations
Website: www.creating-change.org
Email:
Phone: (617) 299-1610

Date Research Evidence Last Reviewed by CEBC: February 2021

Date Program Content Last Reviewed by Program Staff: November 2021

Date Program Originally Loaded onto CEBC: December 2021