Clinical trial NCT05155930: Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy
Official title: Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy for Trauma-related Symptoms Among Complexly Traumatized Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Depression
Lead sponsor: Justice Resource Institute
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS) total score from pre- to post-treatment and 1-month follow up
timeFrame: Change from baseline in PTSD symptom severity at up to 16 weeks of treatment and 1-month follow up.
Secondary outcomes:
measure: Change in PTSD symptoms per the Davidson Trauma Scale (DTS) across four study time points
timeFrame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
measure: Change in symptoms of depression per the Beck Depression Inventory (BDI) across 4 study time points
timeFrame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
measure: Change in interoceptive awareness per the Multidimensional Assessment of Interoceptive Awareness (MAIA) across 4 study time points
timeFrame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
measure: Change in symptoms of dissociation per the Structured Interview for Disorders of Extreme Stress, Self-Report Version (SIDES-SR) over 4 study time points
timeFrame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
measure: Change in self-compassion per the Self Compassion Scale over four study time points
timeFrame: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
Other outcomes:
Locations:
Study officials:
affiliation: Trauma Center
name: Hilary Hodgdon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.