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

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: Completed
• Conditions: Depression; PTSD
• Intervention / Treatment: Behavioral: Internal Family Systems (IFS)

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: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IFS; Internal Family Systems (IFS)	Behavioral: Internal Family Systems (IFS); Weekly individual psychotherapy

What is the study measuring?

Primary Outcome Measures

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	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

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms per the Davidson Trauma Scale (DTS) across four study time points	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	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	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	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	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

• Sponsor: Justice Resource Institute
• Investigators: Principal Investigator: Hilary Hodgdon, Ph.D., Trauma Center

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): March 18, 2014
• Primary Completion (Actual): July 15, 2016
• Study Completion (Actual): July 15, 2016

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID 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