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

• Sponsor: Justice Resource Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT05155930
• Collaborator: (none)
• Enrollment: 17
• Arm: 1
• Actual Duration (Months): 27.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
PTSD; Depression	Behavioral: Internal Family Systems (IFS)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The Internal Family Systems (IFS) model of psychotherapy is a trauma-informed promising practice that has shown promise for individuals who struggle with trauma related symptoms including PTSD, dissociation and depression, as well as disruptions in self-concept and self-regulation. IFS places a heavy emphasis on aiding individuals in building an internalized sense of self-efficacy and self-compassion that may then support the development of self-regulatory capacity and reductions in trauma-related symptoms.The Internal Family Systems (IFS) model of psychotherapy is a trauma-informed promising practice that has shown promise for individuals who struggle with trauma related symptoms including PTSD, dissociation and depression, as well as disruptions in self-concept and self-regulation. IFS places a heavy emphasis on aiding individuals in building an internalized sense of self-efficacy and self-compassion that may then support the development of self-regulatory capacity and reductions in trauma-related symptoms.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy for Trauma-related Symptoms Among Complexly Traumatized Adults
• Actual Study Start Date: Mar 18, 2014
• Actual Primary Completion Date: Jul 15, 2016
• Actual Study Completion Date: Jul 15, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Clinician Administered PTSD Scale (CAPS) total score from pre- to post-treatment and 1-month follow up [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.

Secondary Outcome Measures

1. Change in PTSD symptoms per the Davidson Trauma Scale (DTS) across four study time points [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.

2. Change in symptoms of depression per the Beck Depression Inventory (BDI) across 4 study time points [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.

3. Change in interoceptive awareness per the Multidimensional Assessment of Interoceptive Awareness (MAIA) across 4 study time points [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.

4. Change in symptoms of dissociation per the Structured Interview for Disorders of Extreme Stress, Self-Report Version (SIDES-SR) over 4 study time points [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.

5. Change in self-compassion per the Self Compassion Scale over four study time points [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 56 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Justice Resource Institute

Investigators

• Principal Investigator: Hilary Hodgdon, Ph.D., Trauma Center

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Justice Resource Institute
• ClinicalTrials.gov Identifier: NCT05155930
• Other Study ID Numbers: JRI 2014-02
• First Posted: Dec 14, 2021
• Last Update Posted: Dec 14, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Dec 14, 2021