- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02330744
The Neurobiology of Approach Avoidance Training in Depression (ACTIV8)
31. august 2017 opdateret af: Charles Taylor, University of California, San Diego
The purpose of this study is to test the effects of a computerized approach/avoidance training (AAT) procedure on behavioral, affective, and brain mechanisms that are important for reward sensitivity and well-being in individuals diagnosed with major depression.
The training procedure is designed to modify automatic approach responses for positive social stimuli.
The primary aim is to determine the effects of approach/avoidance training on the functioning of brain systems during reward processing in individuals diagnosed with major depression.
A secondary aim will determine whether brain activation patterns following approach/avoidance training predict subsequent affective and behavioral responses during reward processing.
An exploratory aim will test whether completing the approach/avoidance training procedure in combination with a brief computer-delivered behavioral activation program for depression will produce larger changes in depression symptoms, positive emotions, and social relationship functioning from pre- to post-intervention compared to the control training procedure.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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San Diego, California, Forenede Stater, 92037-0855
- University of California, San Diego; Psychiatry Clinical Research
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ages 18-55
- Principal psychiatric diagnosis of major depressive disorder
- Patient Health Questionnaire - 9 item score ≥ 10
- Ability to read and speak English sufficiently to complete study procedures
Exclusion Criteria:
- History of psychosis, mania, or substance dependence
- Current severe medical disorder that requires inpatient treatment or frequent medical follow ups including but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, sever coronary artery disease, sever peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. HIV), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness > 30 minutes
- Current use of the following medications: antidepressants, benxodiazepines, antipsychotics, mood stabilizers, or other drugs that can acutely affect the hemodynamic response (methylphenidate and acetazolamide)
- Caffeine intake > 10 cups/day or recent significant changes in consumption
- MRI exclusions, including claustrophobia, cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, women who are or may be pregnant (determined by a positive pregnancy test), women using an intrauterine device, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear, tongue or face rings.
- Concurrent psychosocial treatment: Participants completing ongoing psychosocial treatment will be required to meet a 12-week stability criteria so that symptom changes as a result of other psychosocial treatments are not confounded with changes due to the research.
- Inability to complete the initial assessment battery or behavioral training sessions.
- Clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation). These criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Approach-positive AAT
Computerized AAT procedure designed to increase automatic approach responses for positive social cues.
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One session of approach-positive AAT (Aim 1 and 2) followed by 4 sessions of approach-positive AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).
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Placebo komparator: Control AAT
Computerized AAT procedure in which there is no contingency between arm movement and positive social cues.
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One session of control-AAT (Aim 1 and 2) followed by 4 sessions of control-AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from pre-training in blood oxygen level dependent (BOLD) response in the striatum, amygdala, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI) during reward trials on the Social Incentive Delay (SID) task.
Tidsramme: Post-training (5 minutes)
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Change from pre- to post-training in neural activation during social reward processing.
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Post-training (5 minutes)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Response bias to rewards on the Probabilistic Reward Task (PRT)
Tidsramme: Post-training (20 minutes) and 1 month
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Post-training (20 minutes; Aim 2) and post-AAT plus brief behavioral activation treatment (1 month; Aim 3) reward response bias on the PRT.
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Post-training (20 minutes) and 1 month
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Response to social interaction task
Tidsramme: Post-training (30 minutes) and 1 month
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Post-training (30 minutes; Aim 2) and post-AAT plus brief behavioral activation treatment (1 month; Aim 3) behavioral and emotional response to the social interaction task.
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Post-training (30 minutes) and 1 month
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in depression (Patient Health Questionnaire-9; Beck Depression Inventory II, composite)
Tidsramme: 1 month
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Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in symptoms of depression.
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1 month
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Change from baseline in positive affect (Positive and Negative Affect Schedule)
Tidsramme: 1 month
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Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in positive affect.
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1 month
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Change from baseline in social relationship functioning (Social Connectedness Scale - Revised; Interpersonal Outcomes Scale)
Tidsramme: 1 month
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Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in social relationship functioning.
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1 month
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Change from baseline in anhedonia (Mood and Symptom Anxiety Questionnaire; Environmental Reward Observation Scale)
Tidsramme: 1 month
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Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in anhedonia.
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1 month
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Change from baseline in anxiety (State Trait Anxiety Inventory).
Tidsramme: 1 month
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Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in anxiety.
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1 month
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2014
Primær færdiggørelse (Faktiske)
1. april 2017
Studieafslutning (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først indsendt
24. december 2014
Først indsendt, der opfyldte QC-kriterier
2. januar 2015
Først opslået (Skøn)
5. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 21695
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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