Intrusive Negative ThinkingNCT02394704
Intervention for Intrusive Negative Thinking
A study testing Sensory attention training in people with Intrusive Negative Thinking, run by University of Pittsburgh at 1 site in United States.
Trial summary
Intrusive negative thinking styles such as rumination are typical of many psychiatric disorders, are difficult to treat, and predict poor treatment outcome. The investigators propose to evaluate a new intervention for negative thinking that capitalizes and builds on the preserved ability to attend to physical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intrusive Negative Thinking
- What is being tested?
- Sensory attention training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 17 Aug 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed study consent document
- Native English speakers (learned English before age 5)
- Right handed
- 20/30 vision or better
- Free from benzodiazepines and betablockers within 8 hours of evaluations
- Subject specific Inclusion Criteria
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- Endorsement of chronic and intrusive negative thinking
- High scores on rumination; Response Style Questionnaire (RSQ >= 44)
- Automatic Negative Thoughts Questionnaire (ATQ >= 48)
- Dysphoria; Quick Inventory of Depressive Symptomatology (QIDS>= 8)
- Must be in current treatment (either Intensive Outpatient Therapy, regular therapy sessions with a licensed provider, or close care by a psychiatrist). This is to ensure the research team is not the patient's only care provider, as this intervention is intended to be adjunct with therapy.
Who cannot join
- Refusal or inability to provide informed consent
- Current alcohol or substance dependence
- Psychotic disorders or psychosis
- Neurological disorders (stroke, Alzheimer's, Parkinson's, epilepsy, etc.)
- Inability to complete questionnaires in English. The justification is that many of the primary analyses involve assessment of change in self-reported symptoms using measures normed in English. Participants must thus be able to read those measures to give valid indications of the extent to which they have responded to the intervention.
- Current use of any psychotropic drugs thought to affect learning, including antipsychotics, anticonvulsants, stimulants, and anti-Parkinsonian drugs. Current is defined as within 2 weeks of testing, 4 weeks for fluoxetine.
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- Chronic pain that could be exacerbated by transcutaneous electrical stimulation
- Having any eye problems or difficulties in corrected vision or hearing
- Having a North American Adult Reading Test (NAART) equivalent Full Scale Intelligence Quotient < 85
- Being pregnant. Determined by self-report at the interview and by a pregnancy test
- Severe or poorly controlled concurrent medical disorders that may cause thinking disruptions or require medication that could cause negative thinking
- Current use of medications that could cause affect thinking symptoms. That is, participants need to be able to think clearly to complete the proposed information processing tasks. And they need to be able to learn to be able to make use of the intervention. Medications which compromise clear thinking or which block learning will thus be considered exclusion criteria.
- Any implanted electrical device (pacemaker, vagus nerve stimulator implant, etc.) or prior treatment with a vagus nerve stimulator
- Underwent electroconvulsive therapy (ECT) < 9 months prior to study entry.
- People who have foreign objects in their body that are not cleared for safety at 3 Tesla scanning, such as aneurysm clips or pacemakers, will be excluded from the fMRI portion of the study.
- Participants deemed "not a good fit" for the study for other reasons (such as, but not limited to, continually arriving late or rescheduling, not being a trustworthy historian or accurate reporter of symptoms, being belligerent with study staff, or presenting an active suicide risk) can also be excluded.
- Any heart condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Graduated Sensory Salience as an Intervention for Intrusive Negative Thinking
Intrusive negative thinking styles such as rumination are typical of many psychiatric disorders, are difficult to treat, and predict poor treatment outcome. The investigators propose to evaluate a new intervention for negative thinking that capitalizes and builds on the preserved ability to attend to physical sensation. The investigators will examine changes in physiological mechanisms and symptoms.
Read the detailed description
Intrusive negative cognitions are key features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention capitalizing on a preserved neurocircuitry for attending to evolutionarily salient somatosensory stimuli can be used to train attentional mechanisms to override otherwise pre-potent negative cognitions. The initial period will involve open-label intervention refinement and mechanistic evaluation of mechanism; N=35 individuals with high levels of intrusive negative cognitions and dysphoria will be assessed pre/post intervention in the graded sensory training condition. Success will suggest a new intervention pathway for a traditionally treatment-resistant dimension of psychopathology. The second phase will be a randomized trial of 70 participants equally allocated to graded and non-graded training conditions.
- Conditions
- Intrusive Negative Thinking
- Being tested
- Sensory attention training
- Keywords
- Rumination, Sensory processing, Non-pharmacological intervention, Depression, Anxiety, PTSD
- Medical subject headings
- Rumination Syndrome, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory attention trainingOther
Participants will be instructed to attend to sensory stimuli and to press a button as quickly and accurately as possible while ruminating. Stimuli will consist of vibration via a wearable subwoofer or non-painful electrical muscle stimulation (10Hz biphasic current with a pulse width of 200us with rectangular 2" electrodes placed on the back near the shoulders) or vibratory stimulation with a vibroacoustic element placed on the back near the shoulders. Up to four sessions will be approximately 45 minutes, over the course of two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Graded sensory attention training | Experimental | Sensory stimuli will begin at a maximal tolerable intensity and decrease in intensity throughout the training, to shift from involuntary to voluntary attentional focus. Receives: Other: Sensory attention training |
| Non-graded sensory attention training | Active comparator | Sensory stimuli will begin and be maintained at a minimal detectable intensity to maximize voluntary attentional training. Receives: Other: Sensory attention training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained attention composite (computer based tasks and physiological measures)
Sustained attention is operationalized by performance on computer-based tasks (sensitivity, reaction times) and associated physiological measures (pupil dilation, eye movements, heart rate, EEG) and central measures (fMRI derived reactivity in affect, somatosensory, and attention networks). These metrics will be interpreted together as a meta-analytic composite by counting the number of component measures with significant change in association with the intervention in comparison to a permutation-test derived critical number of indices change under the null hypothesis given the autocorrelation of the administered measures.
Measured: two weeks (five intervention days)
Secondary outcomes (2)
Depressive severity (patient self-report)
Clinical variables determined by patient self-report.
Measured: two weeks (five intervention days)
Rumination (patient self-report)
Clinical variables determined by patient self-report.
Measured: two weeks (five intervention days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start1 Nov 2015
- Primary completion9 Jun 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusive Negative ThinkingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Liberos LLC
- Responsible party
- Principal investigator, Greg Siegle, University of Pittsburgh
- Investigators
- Greg J Siegle, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394704
- Sponsor's protocol ID
- PRO13040640
- Status last verified
- Dec 2021
- First submitted
- 3 Mar 2015
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graduated Sensory Salience as an Intervention for Intrusive Negative Thinking
- ClinicalTrials.gov ID
- NCT02394704
- Acronym / sponsor ID
- PRO13040640
- Conditions
- Intrusive Negative Thinking
- Keywords
- Rumination, Sensory processing, Non-pharmacological intervention, Depression, Anxiety, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Liberos LLC
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 20 Mar 2015 (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.
Intrusive negative thinking styles such as rumination are typical of many psychiatric disorders, are difficult to treat, and predict poor treatment outcome. The investigators propose to evaluate a new intervention for negative thinking that capitalizes and builds on the preserved ability to attend to physical sensation. The investigators will examine changes in physiological mechanisms and symptoms.
Detailed description
Intrusive negative cognitions are key features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention capitalizing on a preserved neurocircuitry for attending to evolutionarily salient somatosensory stimuli can be used to train attentional mechanisms to override otherwise pre-potent negative cognitions. The initial period will involve open-label intervention refinement and mechanistic evaluation of mechanism; N=35 individuals with high levels of intrusive negative cognitions and dysphoria will be assessed pre/post intervention in the graded sensory training condition. Success will suggest a new intervention pathway for a traditionally treatment-resistant dimension of psychopathology. The second phase will be a randomized trial of 70 participants equally allocated to graded and non-graded training conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graded sensory attention training | Experimental | Other: Sensory attention trainingSensory stimuli will begin at a maximal tolerable intensity and decrease in intensity throughout the training, to shift from involuntary to voluntary attentional focus. |
| Non-graded sensory attention training | Active comparator | Other: Sensory attention trainingSensory stimuli will begin and be maintained at a minimal detectable intensity to maximize voluntary attentional training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed study consent document
- Native English speakers (learned English before age 5)
- Right handed
- 20/30 vision or better
- Free from benzodiazepines and betablockers within 8 hours of evaluations
Key exclusion criteria (17 listed)
- Refusal or inability to provide informed consent
- Current alcohol or substance dependence
- Psychotic disorders or psychosis
- Neurological disorders (stroke, Alzheimer's, Parkinson's, epilepsy, etc.)
- Inability to complete questionnaires in English. The justification is that many of the primary analyses involve assessment of change in self-reported symptoms using measures normed in English. Participants must thus be able to read those measures to give valid indications of the extent to which they have responded to the intervention.
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 |
|---|---|---|
| Sensory attention trainingParticipants will be instructed to attend to sensory stimuli and to press a button as quickly and accurately as possible while ruminating. Stimuli will consist of vibration via a wearable subwoofer or non-painful electrical muscle stimulation (10Hz biphasic current with a pulse width of 200us with rectangular 2" electrodes placed on the back near the shoulders) or vibratory stimulation with a vibroacoustic element placed on the back near the shoulders. Up to four sessions will be approximately 45 minutes, over the course of two weeks. | Other | Graded sensory attention training, Non-graded sensory attention training |
Primary outcome
Sustained attention composite (computer based tasks and physiological measures)
Time frame: two weeks (five intervention days)
Sustained attention is operationalized by performance on computer-based tasks (sensitivity, reaction times) and associated physiological measures (pupil dilation, eye movements, heart rate, EEG) and central measures (fMRI derived reactivity in affect, somatosensory, and attention networks). These metrics will be interpreted together as a meta-analytic composite by counting the number of component measures with significant change in association with the intervention in comparison to a permutation-test derived critical number of indices change under the null hypothesis given the autocorrelation of the administered measures.
2 secondary outcomes
Depressive severity (patient self-report)
Time frame: two weeks (five intervention days)
Rumination (patient self-report)
Time frame: two weeks (five intervention days)
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 7 Dec 2021.
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.
Greg J Siegle, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory attention training in people with Intrusive Negative Thinking, run by University of Pittsburgh 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 11 inclusion and 17 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 7 Dec 2021. 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?
Sustained attention composite (computer based tasks and physiological measures) (time frame: two weeks (five intervention days)). 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 7 Dec 2021.