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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05155930
Other study ID # JRI 2014-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 18, 2014
Est. completion date July 15, 2016

Study information

Verified date November 2021
Source Justice Resource Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 15, 2016
Est. primary completion date July 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 56 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Internal Family Systems (IFS)
Weekly individual psychotherapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Justice Resource Institute

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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