Posttraumatic Stress DisorderNCT01259921
EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD
A study testing neurofeedback in people with Posttraumatic Stress Disorder, run by Justice Resource Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether neurofeedback (NF) training can significantly reduce the symptoms of Posttraumatic Stress Disorder (PTSD) in individuals with significant affect dysregulation and chronic, treatment-resistant PTSD. The primary aims of this study include: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAPS score of 60 or over
- t-score of 70 or over on the affect dysregulation subscale of the IASC; AND
- Treatment-unresponsiveness as defined by having had at least 3 years of prior treatment focused on dealing with the consequences of the index trauma, or having been in treatment with more than three providers during the preceding decade
Who cannot join
- Serious non-stable medical illness
- GAF < 40
- Bipolar disorder, obsessive-compulsive disorder (OCD), schizophrenia, and other psychotic disorder, or documented organic impairment
- Active suicidal risk, self-injury or physical aggression toward others within the past year
- Substance dependence or abuse in the past 6 months, as defined by DSM IV criteria
- Individuals taking a benzodiazepine more than twice per week (non-response seen in pilot work) AND
- Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
the Trauma Center at JRI
Brookline, Massachusetts, 02446
About this study
Official title: Application of Neurofeedback as a Mechanism of Affect Regulation Treatment of Adults With Complex Adaptation to Chronic Interpersonal Trauma Exposure
The purpose of this study is to determine whether neurofeedback (NF) training can significantly reduce the symptoms of Posttraumatic Stress Disorder (PTSD) in individuals with significant affect dysregulation and chronic, treatment-resistant PTSD. The primary aims of this study include:
- To examine whether NF has the potential to significantly reduce symptoms of PTSD.
- To examine whether NF training can specifically target the area of affect regulation.
- To examine the mechanism of NF through elucidating the relationship between affect regulation and PTSD symptom change.
Read the detailed description
Deficits in affect regulation are associated with a high rate of treatment failure to well-established evidence-based treatments for Posttraumatic Stress Disorder (PTSD), and deficits in this domain are most frequently found in individuals with chronic treatment-resistant PTSD. Aside from one psychological treatment intervention for adult female survivors of child sexual abuse, no published study has targeted improving affect regulation in treatment refractory PTSD. The aim of this study is to test and refine EEG neurofeedback (NF) as an effective treatment for PTSD associated with high levels of affect dysregulation. We believe improved affect regulation will lead to an overall improvement in functioning by addressing deficits in executive functioning in PTSD.
Primary Aim: The primary goal of the research is to refine and evaluate NF training for adults with treatment-resistant PTSD, specifically targeting the domain of affect regulation. We will evaluate the following questions:
- Will NF decrease chronic PTSD symptoms in a treatment-resistant sample of adults with childhood onset PTSD, as measured with the CAPS and the DTS? Hypothesis 1: Subjects in the active treatment condition will show significantly greater decreases on the CAPS and DTS than subjects in the placebo condition.
- Will NF improve affect regulation, as measured by the IASC? Hypothesis 2: Subjects in the active treatment condition will show significantly greater improvement on the affect dysregulation subscale of the IASC than individuals in the placebo condition.
- Will affect regulation, as measured by the IASC, mediate the relationship of NF training and PTSD, as measured with the DTS? Hypothesis 3: The affect dysregulation subscale of the IASC will significantly mediate the relationship between NF and DTS scores while DTS scores will not significantly mediate affect dysregulation.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- neurofeedback
- Keywords
- EEG biofeedback, neurofeedback, PTSD, Affect Regulation, Chronic Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofeedbackBehavioural
Also called EEG Spectrum International, Thought Technologies, ProComp 2
Operant conditioning of the EEG provided by computer reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback T4-P4 | Experimental | 40 sessions of SMR neurofeedback training using T4-P4 placement administered twice weekly Receives: Behavioral: neurofeedback |
| Neurofeedback T3-T4 | Active comparator | 40 sessions of SMR neurofeedback using T3-T4 placement training administered twice weekly Receives: Behavioral: neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician Administered PTSD Scale Score
The CAPS is considered the gold standard for the assessment of PTSD (National Center for PTSD Research). It is a clinician administered 30-item interview that corresponds to DSM-IV criteria for PTSD. Each item of the CAPS has two parts, frequency and intensity, which are both scored on a 5-point scale from 0 to 4. A general cut-off rule of frequency greater than or equal to 1 and intensity greater than or equal to 2 for a symptom to count towards diagnosis will be employed in assigning PTSD diagnosis.
Measured: Participants are assessed at baseline (prior to beginning training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)
Secondary outcomes (2)
Change in Davidson Trauma Scale Score
This is a well validated self-report measure of PTSD with clinical reference norms for adults.
Measured: Participants are assessed at baseline (prior to beginning training), every 4 weeks (corresponding to 8 sessions of training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)
Change in Inventory of Altered Self-Capacities Score
The IASC is a 63-item standardized measure of disturbed functioning in relation to self and others. The IASC measures seven domains of functioning: Interpersonal Conflicts, Idealization-Disillusionment, Abandonment Concerns, Identity Impairment, Susceptibility to Influence, Affect Dysregulation, and Tension Reduction Activities.
Measured: Participants are assessed at baseline (prior to beginning training), every 4 weeks (corresponding to 8 sessions of training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionDec 2012
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 Posttraumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- EEG Biofeedback versus wait list control condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justice Resource Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bessel van der Kolk, M.D., Principal investigator, Justice Resource InstituteMark Gapen, Ph.D., Study director, Justice Resource Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259921
- Sponsor's protocol ID
- ANS2008-06
- Status last verified
- Jun 2011
- First submitted
- 13 Dec 2010
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Gapen M, van der Kolk BA, Hamlin E, Hirshberg L, Suvak M, Spinazzola J. A Pilot Study of Neurofeedback for Chronic PTSD. Appl Psychophysiol Biofeedback. 2016 Sep;41(3):251-61. doi: 10.1007/s10484-015-9326-5.
PubMed 26782083
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Neurofeedback as a Mechanism of Affect Regulation Treatment of Adults With Complex Adaptation to Chronic Interpersonal Trauma Exposure
- ClinicalTrials.gov ID
- NCT01259921
- Acronym / sponsor ID
- ANS2008-06
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- EEG biofeedback, neurofeedback, PTSD, Affect Regulation, Chronic Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Justice Resource InstituteUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Dec 2010 (estimated)
- 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.
The purpose of this study is to determine whether neurofeedback (NF) training can significantly reduce the symptoms of Posttraumatic Stress Disorder (PTSD) in individuals with significant affect dysregulation and chronic, treatment-resistant PTSD. The primary aims of this study include:
- To examine whether NF has the potential to significantly reduce symptoms of PTSD.
- To examine whether NF training can specifically target the area of affect regulation.
- To examine the mechanism of NF through elucidating the relationship between affect regulation and PTSD symptom change.
Detailed description
Deficits in affect regulation are associated with a high rate of treatment failure to well-established evidence-based treatments for Posttraumatic Stress Disorder (PTSD), and deficits in this domain are most frequently found in individuals with chronic treatment-resistant PTSD. Aside from one psychological treatment intervention for adult female survivors of child sexual abuse, no published study has targeted improving affect regulation in treatment refractory PTSD. The aim of this study is to test and refine EEG neurofeedback (NF) as an effective treatment for PTSD associated with high levels of affect dysregulation. We believe improved affect regulation will lead to an overall improvement in functioning by addressing deficits in executive functioning in PTSD.
Primary Aim: The primary goal of the research is to refine and evaluate NF training for adults with treatment-resistant PTSD, specifically targeting the domain of affect regulation. We will evaluate the following questions:
- Will NF decrease chronic PTSD symptoms in a treatment-resistant sample of adults with childhood onset PTSD, as measured with the CAPS and the DTS? Hypothesis 1: Subjects in the active treatment condition will show significantly greater decreases on the CAPS and DTS than subjects in the placebo condition.
- Will NF improve affect regulation, as measured by the IASC? Hypothesis 2: Subjects in the active treatment condition will show significantly greater improvement on the affect dysregulation subscale of the IASC than individuals in the placebo condition.
- Will affect regulation, as measured by the IASC, mediate the relationship of NF training and PTSD, as measured with the DTS? Hypothesis 3: The affect dysregulation subscale of the IASC will significantly mediate the relationship between NF and DTS scores while DTS scores will not significantly mediate affect dysregulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- EEG Biofeedback versus wait list control condition.
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback T4-P4 | Experimental | Behavioral: neurofeedback40 sessions of SMR neurofeedback training using T4-P4 placement administered twice weekly |
| Neurofeedback T3-T4 | Active comparator | Behavioral: neurofeedback40 sessions of SMR neurofeedback using T3-T4 placement training administered twice weekly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CAPS score of 60 or over
- t-score of 70 or over on the affect dysregulation subscale of the IASC; AND
- Treatment-unresponsiveness as defined by having had at least 3 years of prior treatment focused on dealing with the consequences of the index trauma, or having been in treatment with more than three providers during the preceding decade
Key exclusion criteria (7 listed)
- Serious non-stable medical illness
- GAF < 40
- Bipolar disorder, obsessive-compulsive disorder (OCD), schizophrenia, and other psychotic disorder, or documented organic impairment
- Active suicidal risk, self-injury or physical aggression toward others within the past year
- Substance dependence or abuse in the past 6 months, as defined by DSM IV criteria
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 |
|---|---|---|
| neurofeedbackAlso: EEG Spectrum International, Thought Technologies, ProComp 2Operant conditioning of the EEG provided by computer reinforcement. | Behavioural | Neurofeedback T3-T4, Neurofeedback T4-P4 |
Primary outcome
Change in Clinician Administered PTSD Scale Score
Time frame: Participants are assessed at baseline (prior to beginning training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)
The CAPS is considered the gold standard for the assessment of PTSD (National Center for PTSD Research). It is a clinician administered 30-item interview that corresponds to DSM-IV criteria for PTSD. Each item of the CAPS has two parts, frequency and intensity, which are both scored on a 5-point scale from 0 to 4. A general cut-off rule of frequency greater than or equal to 1 and intensity greater than or equal to 2 for a symptom to count towards diagnosis will be employed in assigning PTSD diagnosis.
2 secondary outcomes
Change in Davidson Trauma Scale Score
Time frame: Participants are assessed at baseline (prior to beginning training), every 4 weeks (corresponding to 8 sessions of training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)
Change in Inventory of Altered Self-Capacities Score
Time frame: Participants are assessed at baseline (prior to beginning training), every 4 weeks (corresponding to 8 sessions of training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)
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 15 Aug 2019.
- Background: PubMed 26782083Gapen M, van der Kolk BA, Hamlin E, Hirshberg L, Suvak M, Spinazzola J. A Pilot Study of Neurofeedback for Chronic PTSD. Appl Psychophysiol Biofeedback. 2016 Sep;41(3):251-61. doi: 10.1007/s10484-015-9326-5.
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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.
Bessel van der Kolk, M.D. principal investigator
Justice Resource Institute
Mark Gapen, Ph.D. study director
Justice Resource Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurofeedback in people with Posttraumatic Stress Disorder, run by Justice Resource Institute at 1 site in United States.
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 3 inclusion and 7 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Score (time frame: Participants are assessed at baseline (prior to beginning training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)). 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 NCT01259921, 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 15 Aug 2019.