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Completed

NCT Number: NCT05155930

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

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

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Key information

Conditions

PTSD Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internal Family Systems (IFS)

Behavioral

Weekly individual psychotherapy

Primary outcomes

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

    Time frame: 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 outcomes

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

    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.

    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

    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.

    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

    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.

    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

    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.

    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

    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.

    26 item self report outcome measure assessing components of compassion towards the self including self-kindness, common humanity, and mindfulness.

Sponsors and collaborators

Lead sponsor

Justice Resource Institute

Other

Registry information

Official study title

Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy for Trauma-related Symptoms Among Complexly Traumatized Adults

Acronym: IFS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2021
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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