PTSDIFSNCT05155930
Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy
A study testing Internal Family Systems (IFS) in people with PTSD and Depression, run by Justice Resource Institute.
Trial summary
Study examining the effectiveness of 16 weeks of Internal Family Systems (IFS) therapy for adults with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 56 years
- Conditions the study is for
- PTSD, Depression
- What is being tested?
- Internal Family Systems (IFS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2014to 15 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy for Trauma-related Symptoms Among Complexly Traumatized Adults
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.
- Conditions
- PTSD, Depression
- Being tested
- Internal Family Systems (IFS)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Family Systems (IFS)Behavioural
Weekly individual psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| IFS | Experimental | Internal Family Systems (IFS) Receives: Behavioral: Internal Family Systems (IFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Self-report of PTSD symptoms per DSM IV criteria.
Measured: 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
21-item, self-report measure of symptoms of depression.
Measured: 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
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.
Measured: 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
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.
Measured: 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
26 item self report outcome measure assessing components of compassion towards the self including self-kindness, common humanity, and mindfulness.
Measured: Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start18 Mar 2014
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justice Resource Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilary Hodgdon, Ph.D., Principal investigator, Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155930
- Sponsor's protocol ID
- JRI 2014-02
- Acronym
- IFS
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2017
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy for Trauma-related Symptoms Among Complexly Traumatized Adults
- ClinicalTrials.gov ID
- NCT05155930
- Acronym / sponsor ID
- IFS / JRI 2014-02
- Conditions
- PTSD, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Justice Resource InstituteUniversity, hospital or other
- Study start
- 18 Mar 2014 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| IFS | Experimental | Behavioral: Internal Family Systems (IFS)Internal Family Systems (IFS) |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal Family Systems (IFS)Weekly individual psychotherapy | Behavioural | IFS |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- BackgroundHodgdon, 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 dataSharing planned: No. IPD will not be shared with other researchers.
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary Hodgdon, Ph.D. principal investigator
Trauma Center
Questions about this trial
What is this clinical trial studying?
A study testing Internal Family Systems (IFS) in people with PTSD and Depression, run by Justice Resource Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05155930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.