Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy (IFS)

November 30, 2021 updated by: Justice Resource Institute

Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy for Trauma-related Symptoms Among Complexly Traumatized Adults

Study examining the effectiveness of 16 weeks of Internal Family Systems (IFS) therapy for adults with posttraumatic stress disorder (PTSD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluation study of IFS therapy among trauma-impacted adults in order to explore the applicability of IFS with this population, ensure fidelity of treatment administration, and examine initial efficacy. Evaluate the utility of IFS in reducing symptoms of PTSD, dissociation and depression and increasing self-regulatory capacity, self-awareness and self-compassion. 15 subjects between the ages of 18 and 56 who are receiving 16, 90-minute sessions of IFS therapy by certified IFS practitioners in the community will be recruited for this evaluation study. Blind evaluators will assess treatment effects at pre-treatment, mid-treatment, post-treatment and at one-month follow-up, measuring change in symptoms of PTSD, dissociation and depression, as well as self-regulation, self-compassion, and interoceptive awareness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals between 18 and 58 years old, any race.
  • A minimum two traumatic events prior to the age of 18 years.
  • Current PTSD diagnosis per CAPS assessment with total symptom scores indicative of a moderate degree of severity (i.e. CAPS total score between 55 and 80).
  • Clinically significant depressive symptoms as indicated by a total score of 14 or above on the BDI.

Exclusion Criteria:

  • GAF < 40.
  • Diagnosis of schizophrenia, DID, Bipolar Disorder or other psychotic disorder not stated above.
  • Substance dependence or abuse in the past 6 months, as defined by DSM IV criteria and judged by the PI.
  • Current legal proceedings resulting from the traumatic events.
  • Previous treatment in IFS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IFS
Internal Family Systems (IFS)
Behavioral: Internal Family Systems (IFS)
Weekly individual psychotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Clinician Administered PTSD Scale (CAPS) total score from pre- to post-treatment and 1-month follow up
Time Frame: Change from baseline in PTSD symptom severity at up to 16 weeks of treatment and 1-month follow up.
A 30-item validated instrument that contains frequency and intensity scales for PTSD symptoms . Subscales assess intrusion, avoidance, arousal and associated affective features.
Change from baseline in PTSD symptom severity at up to 16 weeks of treatment and 1-month follow up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PTSD symptoms per the Davidson Trauma Scale (DTS) across four study time points
Time Frame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
Self-report of PTSD symptoms per DSM IV criteria.
Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
Change in symptoms of depression per the Beck Depression Inventory (BDI) across 4 study time points
Time Frame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
21-item, self-report measure of symptoms of depression.
Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
Change in interoceptive awareness per the Multidimensional Assessment of Interoceptive Awareness (MAIA) across 4 study time points
Time Frame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
32-item, self-report measure that assesses interoceptive body awareness across eight distinct but related dimensions: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting.
Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
Change in symptoms of dissociation per the Structured Interview for Disorders of Extreme Stress, Self-Report Version (SIDES-SR) over 4 study time points
Time Frame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
45 item, validated self-report measure assessing six domains of impairment secondary to complex trauma exposure. Assessed areas include alterations in (a) regulation of affect and impulses, (b) attention and consciousness, (c) self-perception, (d) relation with others, (e) somatization, and (f) systems of meaning.
Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
Change in self-compassion per the Self Compassion Scale over four study time points
Time Frame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
26 item self report outcome measure assessing components of compassion towards the self including self-kindness, common humanity, and mindfulness.
Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Justice Resource Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hilary Hodgdon, Ph.D., Trauma Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Hodgdon, H.B., Gustella-Anderson, F., Southwell, E., Hrubec, W., & Schwartz, R. (November, 2017). Pilot Study of Internal Family Systems Therapy for Adults with a History of Childhood Trauma and Chronic PTSD. Poster presented at the annual meeting of International Society of Traumatic Stress Studies (ISTSS),Chicago, IL.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JRI 2014-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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