NCT05155930

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
Last Updated

December 14, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

March 24, 2017

Last Update Submit

November 30, 2021

Conditions

Outcome Measures

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.

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

Secondary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (1)

IFS

EXPERIMENTAL

Internal Family Systems (IFS)

Behavioral: Internal Family Systems (IFS)

Interventions

Weekly individual psychotherapy

IFS

Eligibility Criteria

Age18 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Hilary Hodgdon, Ph.D.

    Trauma Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2017

First Posted

December 14, 2021

Study Start

March 18, 2014

Primary Completion

July 15, 2016

Study Completion

July 15, 2016

Last Updated

December 14, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers.