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Cognitive Training for Mood and Anxiety Disorders

19 juli 2017 bijgewerkt door: Icahn School of Medicine at Mount Sinai
The purpose of this study is to investigate the effects of a computerized cognitive training program (an attention and memory exercise performed on a computer) on thinking and memory in individuals with mood and anxiety disorders, and to begin to test whether this training affects symptoms of depression or anxiety.

Studie Overzicht

Gedetailleerde beschrijving

The objective of this research protocol is to collect feasibility and pilot data investigating the efficacy of a computerized cognitive training paradigm. The training paradigm aims to enhance cognitive control for emotional information-processing and reduce the negative affective biases observed among those experiencing mood and anxiety symptoms and disorders. This protocol will also investigate whether improvements in cognitive control and affective bias are associated with changes in mood and anxiety symptoms. Participants will undergo 6 weeks of cognitive training sessions, with three sessions per week.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

28

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • New York
      • New York, New York, Verenigde Staten, 10029
        • Icahn School of Medicine at Mount Sinai

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Primary, current Axis I diagnosis of a mood disorder (e.g., major depressive disorder (MDD); bipolar disorder, currently depressed) or anxiety disorder (PTSD; Generalized Anxiety Disorder (GAD); Social Phobia) according to DSM-IV criteria and SCID-IV diagnosis OR must be free of any psychiatric condition (for the healthy volunteer group)
  • Age 18-80
  • Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process

Exclusion Criteria:

  • A history of drug or alcohol abuse or dependence (DSM-IV criteria) within the previous 6 months
  • Visual impairment that would affect the ability to observe the computerized exercises
  • Motor impairment that would affect the ability to provide a response by quickly pressing a button
  • Patients with mood congruent or mood incongruent psychotic features
  • Primary, current Axis I diagnosis other than MDD, Bipolar Disorder (currently depressed), PTSD, GAD or Social Phobia
  • The presence of axis II personality disorder psychopathology that, in the opinion of the investigator, will interfere with study participation
  • Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
  • Pregnancy in women. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason. A urine pregnancy test will be administered at screening
  • Enrolled participants can be currently taking standard antidepressant or mood stabilizer medication regimens, or benzodiazepine treatment for sleep as needed but not exceeding 3 nights per week. Medication regimens must be stable at the time of study enrollment (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). No medications will be started or discontinued for the purpose of enrollment into the study
  • Subjects must exhibit no or only moderate alcohol use during study participation. Subjects with current excessive use of alcohol (> 8 ounces/day) or participants abusing substances will be ineligible for participation, as such drug use could confound the results. A urine toxicology test will be administered at screening to test for drugs of abuse
  • Participants exhibiting depression symptoms in the severe range (Ham-D > 27) will be excluded from participation as an investigational study such as this may not be suitable
  • Participants exhibiting chronic MDD episodes (defined as a current episode lasting 5+ years) will be excluded from participation as an investigational study such as this may not be suitable

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: emotional memory training exercise
study training exercise - Emotional Faces Memory Task (EFMT)
Actieve vergelijker: memory training exercise
an active control exercise (CT)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of completers to measure feasibility
Tijdsspanne: week 6
comparing the proportion of completers (15-18 sessions) between the in-person participants and the participants completing the exercise on their own computers
week 6

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Depression Symptom Severity
Tijdsspanne: baseline and week 6
Depression symptom severity comparison at week 6 to baseline as measured by the Hamilton Depression Rating Scale (Ham-D) and Quick Inventory of Depressive Symptoms (QIDS-C)
baseline and week 6
Change in Anxiety Symptom Severity
Tijdsspanne: baseline and week 6
Anxiety symptom severity comparison at week 6 to baseline as measured by the Hamilton Anxiety Rating Scale (Ham-A) and Treatment Outcome PTSD Scale (TOP-8)
baseline and week 6
Change in Negative Affective Bias
Tijdsspanne: baseline and week 6
Negative affective bias comparison at week 6 to baseline as measured by the Self-referential Information Processing Task, Affective Go/No-Go, Emotional Stroop, Emotion Faces Recognition Task, Cognitive Style Questionnaire, Ruminative Responses Scale, and Attention Bias Variability Task
baseline and week 6
Change in Neurocognition
Tijdsspanne: baseline and week 6
neurocognition comparison at week 6 to baseline using Digit Span, Letter-Number Sequencing, Hopkins Verbal Learning Test, and Intra-Extra Dimensional Set-Shifting
baseline and week 6

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Brian Iacoviello, PhD, Icahn School of Medicine at Mount Sinai

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2014

Primaire voltooiing (Werkelijk)

20 april 2016

Studie voltooiing (Werkelijk)

20 april 2016

Studieregistratiedata

Eerst ingediend

1 oktober 2014

Eerst ingediend dat voldeed aan de QC-criteria

2 oktober 2014

Eerst geplaatst (Schatting)

3 oktober 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

19 juli 2017

Laatst geverifieerd

1 juli 2017

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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