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Stress Disorders, Post TraumaticNCT01244477

Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)

A study testing Group CPT-C in people with Stress Disorders, Post Traumatic and Trust, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Traumatic experiences can have a profound negative effect on the lives and well-being of both the people who experience them and their loved ones. For those who experience post-traumatic stress disorder (PTSD), their interpersonal difficulties and social support further impact the success of treatment such that… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Stress Disorders, Post Traumatic, Trust
What is being tested?
Group CPT-C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
16 May 2011to 30 Jun 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Meet criteria for PTSD on the Clinician Administered PTSD Scale (CAPS)
  • Priority will be given to Veterans aged 18-50 who have had an onset of symptoms in the past 10 years and are Veterans of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)
  • Have been referred for placement in CPT treatment by a clinician in the Trauma Recovery Program at the Michael E DeBakey VA Medical Center (MEDVAMC) or an eligible Veteran who contacts study staff.
  • Are able to see the computer display clearly with or without magnetic Resonance imaging (MRI)-compatible corrective lenses
  • Are free from current non-psychiatric medical problems impacting cognitive functioning.
  • Are cleared to participate by a treating MEDVAMC clinician
  • Are able to participate in functional MRI (fMRI)

Who cannot join

  • Meet Diagnostic and Statistical Manual-IV (DSM-IV)criteria for drug or alcohol abuse in the past 30 days
  • History of moderate to severe traumatic brain injury based on any of the following:
  • (i) Glasgow Coma Score < 13
  • (ii)alteration of consciousness > 24 hours; loss of consciousness,30 minutes
  • Presence of contraindications to MRI, including but not limited to:
  • claustrophobia
Show all 23Show fewer
  • pacemaker
  • metal in eyes
  • other implants
  • Current neurological or general medical conditions known to impact cognitive and/or emotional functioning, including but limited to:
  • epilepsy
  • Parkinson's disease
  • Huntington's disease
  • Alzheimer's disease
  • stroke
  • chemotherapy for cancer
  • Acute psychological instability as assessed by a Michael E DeBakey VA Medical Center (MEDVAMC) clinician or study staff
  • Concurrent diagnosis of:
  • schizophrenia
  • schizoaffective disorder
  • delusional disorder
  • organic psychosis
  • and subjects taking antipsychotic medication

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Neuroimaging the Impact of Treatment on Neural Substrates of Trust in PTSD

Traumatic experiences can have a profound negative effect on the lives and well-being of both the people who experience them and their loved ones. For those who experience post-traumatic stress disorder (PTSD), their interpersonal difficulties and social support further impact the success of treatment such that interpersonal difficulties are associated with mistrust and predict poor treatment outcome. In this proposal, the investigators use functional neuroimaging to understand the neurobiology of trust and mistrust in people with PTSD and to learn more about how successful treatment can improve trust and social functioning.

Read the detailed description

Substantial recent data highlight the role of social functioning as a primary moderator of therapeutic response in individuals with post-traumatic stress disorder (PTSD) such that interpersonal difficulties and mistrust significantly and negatively impact treatment efficacy (Forbes et al., 2003; Forbes et al., 2005; Forbes et al., 2008). In addition, ample evidence suggests that psychotherapy improves the social and interpersonal lives of psychotherapy clients through improving clients' abilities to regulate their emotions and reduce social isolation (Yalom \& Leszcz, 2005; Foy et al., 2000). While considerable research has been dedicated to exploring the neurobiology of emotional dysregulation associated with PTSD (Rauch, Shin, \& Phelps, 2006; Etkin \& Wager, 2007), and increasing data suggest that diverse psychotherapies affect neural functioning (Beauregard 2007), very little is understood about the neurobehavioral pathology underlying the debilitating interpersonal difficulties in PTSD, or the neurobiological mechanisms accompanying the improvements in social functioning that occur with efficacious therapy.

Thus, the broad goals of this project are two-fold. First, the investigators seek to examine the neural substrates associated with interpersonal dysfunction in PTSD using a social exchange game previously developed to assess interpersonal trust and cooperation in healthy (King-Casas et al., 2005) and psychiatric groups (Chiu et al., 2008; King-Casas et al., 2008). Second, the investigators seek to examine changes in neurobehavioral substrates of social functioning following treatment for Veterans with PTSD. Specifically, the investigators propose to use functional magnetic resonance imaging (fMRI) and behavior within a well-characterized Trust Game to examine the neural substrates associated with interpersonal trust and cooperation in Veterans with PTSD prior to and following empirically supported psychotherapy cognitive processing therapy (CPT) for PTSD.

Thus, the broad goals of this project are two-fold. First, the investigators seek to examine the neural substrates associated with interpersonal dysfunction in PTSD using a social exchange game previously developed to assess interpersonal trust and cooperation in healthy (King-Casas et al., 2005) and psychiatric groups (Chiu et al., 2008; King-Casas et al., 2008). Second, the investigators seek to examine changes in neurobehavioral substrates of social functioning following treatment for veterans with PTSD. Specifically, the investigators propose to use functional magnetic resonance imaging (fMRI) and behavior within a well-characterized Trust Game to examine the neural substrates associated with interpersonal trust and cooperation in veterans with PTSD prior to and following empirically supported psychotherapy cognitive processing therapy (CPT) for PTSD.

Being tested
Group CPT-C
Keywords
Stress Disorders, Post Traumatic, Trust, functional Magnetic Resonance Imaging (fMRI)
Medical subject headings
Combat Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group CPT-CBehavioural

    Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.

Study groups in NCT01244477
Study groupRoleWhat they receive
CPT-CExperimentalParticipants in group CPT-C
Receives: Behavioral: Group CPT-C
Treatment-as-UsualNo interventionParticipants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan

    Measured: Pre & post a 12 week treatment group

  2. The Clinician Administered PTSD Scale (CAPS)

    The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.

    Measured: Pre & post a 12 week treatment group

Secondary outcomes (2)
  1. Behavioral Expression of Trust on the Trust Game

    The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.

    Measured: Pre & post a 12 week treatment group

  2. PTSD Checklist (PCL)

    An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.

    Measured: Administered each week at weekly group sessions or pre-post treatment as usual

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2010 (estimated)
  2. Study start16 May 2011
  3. Primary completion31 May 2013
  4. Study completion30 Jun 2018

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244477
Sponsor's protocol ID
B7760-P
Status last verified
Jun 2019
First submitted
17 Nov 2010
Last updated
27 Jun 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group CPT-C in people with Stress Disorders, Post Traumatic and Trust, run by VA Office of Research and Development 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 7 inclusion and 23 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 27 Jun 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?

Yes. Results are posted in the registry (first posted 2 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan (time frame: Pre & post a 12 week treatment group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Jun 2019.

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