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CompletedNCT05155930IFSUpdated Dec 14, 2021

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

An interventional study of Internal Family Systems (IFS) in PTSD and Depression, sponsored by Justice Resource Institute. Completed. Open to participants aged 18 Years to 56 Years. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by Justice Resource Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Mar 2014, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 56 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • PTSD
  • Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 17 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Justice Resource Institute is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 56 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    IFS

    Internal Family Systems (IFS)

    Behavioral: Internal Family Systems (IFS)

Interventions

  • BehavioralInternal Family Systems (IFS)

    Weekly individual psychotherapy

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline in PTSD symptom severity at up to 16 weeks of treatment and 1-month follow up.

Secondary outcomes

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

    Self-report of PTSD symptoms per DSM IV criteria.

    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.

  2. 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.

    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.

  3. 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.

    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.

  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

    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.

    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.

  5. 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.

    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.

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Study locations

No study locations are listed for this record.

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References and documents

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.

Individual participant data

Plan to share: No — IPD will not be shared with other researchers.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05155930
Lead sponsor
Justice Resource Institute
Responsible party
Sponsor
First posted
Dec 14, 2021
Start date
Mar 18, 2014
Primary completion
Jul 15, 2016
Completion
Jul 15, 2016
Last update
Dec 14, 2021

Study contacts

Hilary Hodgdon, Ph.D.
principal investigator · Trauma Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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