- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04038190
En adfærdsaktiveringsintervention administreret i et College Freshman-orienteringskursus
Et klynge-randomiseret forsøg med en adfærdsaktiveringsintervention administreret i et college Freshman-orienteringskursus
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Overgangen fra gymnasiet til gymnasiet er en udviklingsmæssigt følsom periode, der er høj risiko for eskalering af alkoholforbrug. Selvom risikofyldt drikkeri er et almindeligt problem blandt nybegyndere, er engagementet i behandlingstilbud meget lavt. Lav grad af engagement med behandlingsressourcer kan forekomme, fordi interventioner retter sig direkte mod drikkeri på et tidspunkt, hvor eleverne kan være uinteresserede i at ændre deres drikkeri. Desuden, med et målrettet fokus på alkoholbrug, adresserer de nuværende interventioner heller ikke bekymringerne hos kommende nybegyndere, såsom stress og søvn. Tilgange, der adresserer de problemer, eleverne er mest bekymrede over, og som også indirekte reducerer drikkeri, kan være særligt effektive.
Behavioural Activation (BA) er en intervention, der indirekte adresserer psykopati ved at vejlede individer til at identificere mål i deres liv og opmuntre individer til at engagere sig i forstærkende aktiviteter, der stemmer overens med deres mål (Lejuez et al, 2001). Mens BA oprindeligt blev brugt til at behandle depression, er BA blevet effektivt anvendt til stofbrug, fordi BA virker på den samme forstærkende proces, der er involveret i problemdrikning. BA behandler drikkeri uden specifik henvisning til alkoholbrug ved at fokusere på engagement i at styrke aktiviteter, der stemmer overens med elevernes mål. Et pilotstudie gav en indledende indikation af, at en kort BA-intervention administreret i et semesterlangt førsteårsorienteringskursus resulterede i et signifikant fald i drikkerelaterede problemer sammenlignet med standardorientering (Reynolds et al. 2011). Det er bemærkelsesværdigt, at tilgangen aldrig rejste spørgsmålet om at drikke, medmindre den blev rejst af en studerende selv.
Formålet med undersøgelsen er at udføre en fuldt powered klynge randomiseret forsøgstest BA administreret i et semesterlangt (16 ugers) førsteårsorienteringskursus sammenlignet med et standardorienteringskursus i 540 førsteårsstuderende fordelt på 36 kursusafsnit (18 sektioner hver af de BA og standard orienteringsformat). En 5-måneders efterbehandlingsvurdering vil måle virkningernes holdbarhed. Mediationsanalyser vil teste virkningsmekanismer, og moderationsanalyser vil undersøge faktorer relateret til effektivitet. En tilfældig stikprøve på 20 % af deltagerne vil gennemføre en 17 måneders opfølgning, som vil finde sted i slutningen af deres andet år på college, for at undersøge langsigtede effekter. Med denne foreslåede R01 vil efterforskerne teste en lovende intervention med BA, der adresserer faktorer, der begrænser deltagelse i andre programmer ved ikke at målrette alkohol direkte og ved at integrere en intervention i colleges pensum, med den ekstra fordel af at teste mediatorer til at guide det fremtidige arbejde. Denne applikation repræsenterer et første skridt i retning af at udvikle et interventionskursus, der kunne udbredes bredt for at løse det vedvarende college-drikproblem og dets mange konsekvenser.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Kansas
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Lawrence, Kansas, Forenede Stater, 66046
- University of Kansas
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- College freshmen tilmeldt UNIV 101 freshman seminar kurser ved University of Kansas tildelt undersøgelsen
Ekskluderingskriterier:
- Ingen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Adfærdsaktiveringskursus
Adfærdsaktiveringskursustilstand administreret i et orienteringsseminar for førsteårsstuderende på college
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Behavioural Activation (BA) er en intervention, der indirekte adresserer psykopati ved at vejlede individer til at identificere mål i deres liv og opmuntre individer til at engagere sig i forstærkende aktiviteter, der stemmer overens med deres mål (Lejuez et al, 2001).
Mens BA oprindeligt blev brugt til at behandle depression, er BA blevet anvendt effektivt til stofbrug, fordi BA virker på det samme forstærkningssystem, der er fælles for mange lidelser (Daughters et al., 2018).
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Ingen indgriben: Standard orienteringskursus
Standard førsteårs orientering seminar kursus tilstand
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Alcohol Consumption (AUDIT-C Score)
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Alcohol-Use Disorders Identification Test- Consumption Questions (AUDIT-C), which are the first three items of the AUDIT 10-item measure that asses frequency of drinking, typical quantity, and frequency of heavy drinking occasions (Saunders et al, 1993; Bush et al, 1998; DeMartini et al 2012).
Responses are on a likert scale ranging from 0-4.
The 3 items are summed for a total score with a possible range of 0-12, with higher scores indicating riskier drinking behavior.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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The Time Line Follow Back-Computerized (TLFB-C) assessment was used to measure alcohol consumption in the past 30 days (Sobell & Sobell, 2008), or since the prior measurement period.
The measure was used to obtain the number of days during which individuals engaged in high-intensity drinking of 8+ drinks for males or 10+ drinks for females per drinking occasion.
The number of days participants engaged in high intensity drinking was summed per measurement period, and converted to a rate to reflect the number of high intensity drinking days out of the number of days in the measurement period (high intensity drinking days/days in measurement period).
The rate was used because there could be slightly different numbers of days across measurement periods, depending on when participants completed the assessment.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Alcohol-related Problems (AUDIT-P) Score
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Alcohol-Use Disorders Identification Test- Problem questions (AUDIT-P) are the last 7 items of the full AUDIT that assess increased salience of drinking, morning drinking, guilt after drinking, blackouts, alcohol-related injuries, and drinking that others are concerned about (Saunders et al, 1993; O'Hare & Sherrer, 2005).
Responses are on a likert scale ranging from 0-4.
The 7 items were summed for a total score on the AUDIT-P, with a possible range of 0-28, with higher scores indicating greater alcohol-related problems.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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The Alcohol-Use Disorders Identification Test (AUDIT) is designed to assess hazardous alcohol use and alcohol-related problems.
The AUDIT has 10 items (Saunders et al, 1993) and responses are on a likert scale ranging from 0-4.
The 10 items are summed for a total score with a possible range of 0-40, with higher scores indicating greater likelihood of hazardous drinking behavior.
A total score of 8 or higher was used as a binary variable to identify participants with hazardous drinking (score 8+).
Outcome was the proportion of respondents exceeding the clinical cut point.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Depression
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Depression was measured using the Depression Anxiety Stress Scale (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995).
The measure provides scales for depression, anxiety, and stress and conceptualizes the difference between normal and clinical populations as a matter of degree.
The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia with 7 items.
Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21.
Higher scores indicate greater depression.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Binge Eating
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Binge eating was measured with the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013).
The binge eating subscale was used in the study, which includes items on overeating and loss of control eating.
The binge eating subscale has 8 items with Likert scale responses from 0=never to 4= very often.
Items are summed for a scale score ranging from 0-32.
Higher scores indicate more frequent experiences with binge eating behavior.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Stress
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Stress was measured using the Depression Anxiety Stress Scale-21 (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995).
The stress scale score was used to assess stress.
Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21.
Higher scores indicate greater stress.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Delay Discounting Rate
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Delay discounting was calculated from a computer adjusting delay discounting task that asked participants to choose between smaller immediate rewards and larger, delayed rewards.
The reward used in the task was hypothetical money.
Mazur's hyperbolic function, V = A/ 1 + kD, was used to estimate each participant's delay discounting rate (i.e., k) for use in analyses.
For this formula, V is the discounted value of a delayed reward (i.e., indifference point), A is the reward amount, D is the delay in days, and k represents the estimated delay discounting rate.
Greater k values indicated stronger discounting and a preference for immediate monetary rewards.
K values across the sample ranged from -11.06 to 2.43.
Negative values generally indicate stronger discounting, whereas positive values typically represent less steep discounting.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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The Adolescent Reinforcement Survey Schedule - Alcohol Use Version assesses the frequency of past-month engagement in and enjoyment derived from 45 activities (Hallgren et al, 2016).
Each question is posed twice - once to assess the frequency and enjoyment of the activity while using alcohol and the once to assess the frequency and enjoyment of the activity while not using alcohol.
Items range from 0-4.
Frequency and enjoyment items are summed to form respective scores.
From these scales, two subscales are created for alcohol-related reinforcement and alcohol-free reinforcement, calculated as the cross product between frequency and enjoyment items for alcohol-related and alcohol-free questions.
The two subscales were used to calculate the outcome, the total reinforcement ratio (TRR) between alcohol-related and alcohol-free reinforcement.
The ratio has values between 0 and 1, with higher values indicating more relative enjoyment of activities when using alcohol.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Moderator: The Drinking Motives Questionnaire-Revised (DMQ-R) is designed to measure the relative frequency of drinking for four distinct reason motives: enhancement, social, conformity, and coping (Cooper, 1994; Cox & Klinger, 1988). The study used the coping motives scale, which contains 5 items. Items are assessed on a Likert scale ranging from 1-5 and are summed for form a scale score, which higher scores indicating greater endorsement of drinking to cope with stress/distress. Outcome: The outcome used in the analysis was the Alcohol Use Disorder Identification Test (AUDIT) total score; we originally planned to use AUDIT-Consumption and AUDIT-Problems subscales for two separate analyses and outcomes (in parallel with other moderation analyses); however the models did not converge. Therefore, AUDIT total score was used as the outcome in analyses. |
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Grade Point Average (GPA)
Tidsramme: GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)
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Academic performance was measured using participant self-reported grade point average (GPA).
College freshmen first received their GPA in the spring semester of college, which was at the 5 month follow up.
Thus, we examined whether there were significant differences in GPA across treatment and control conditions at 5 month adn 17 month follow ups.
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GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)
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Moderation of Treatment Effects (AUDIT-C) by Sex
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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The moderator used in analyses was sex.
The outcome was the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) subscale score.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Moderation of Treatment Effects (AUDIT-P) by Sex
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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The moderator in the model was sex.
The outcome was the Alcohol Use Disorder Identification Test-Problems (AUDIT-P) subscale score
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tera L Fazzino, PhD, University of Kansas
Publikationer og nyttige links
Generelle publikationer
- Fazzino TL, Lejuez CW, Yi R. A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol. Contemp Clin Trials. 2020 Mar;90:105950. doi: 10.1016/j.cct.2020.105950. Epub 2020 Jan 23.
- Jun D, Fazzino TL. Associations between Alcohol-Free Sources of Reinforcement and the Frequency of Alcohol and Cannabis Co-Use among College Freshmen. Int J Environ Res Public Health. 2023 Feb 7;20(4):2884. doi: 10.3390/ijerph20042884.
- Exum AC, Sutton CA, Bellitti JS, Yi R, Fazzino TL. Delay discounting and substance use treatment outcomes: A systematic review focused on treatment outcomes and discounting methodology. J Subst Use Addict Treat. 2023 Jun;149:209037. doi: 10.1016/j.josat.2023.209037. Epub 2023 Apr 16.
- Fazzino TL, Kunkel A, Bellitti J, Romine RS, Yi R, McDaniel C, Lejuez CW. Engagement with Activity Monitoring During a Behavioral Activation Intervention: A Randomized Test of Monitoring Format and Qualitative Evaluation of Participant Experiences. Behav Change. 2023 Jun;40(2):103-116. doi: 10.1017/bec.2022.7. Epub 2022 Jun 16.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00143954
- 1R01AA027791-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med Depression
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Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RekrutteringAngst | Angst Depression | Depression Angstlidelse | Depression - svær depressiv lidelseNorge
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University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Aktiv, ikke rekrutterendeDepression Moderat | Depression Mild | Depression, teenagerForenede Stater
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ProgenaBiomeTrukket tilbageDepression | Depression, postpartum | Depression, angst | Depression Moderat | Depression Alvorlig | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskForenede Stater
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Bekelu Teka WorkuJimma UniversityIkke rekrutterer endnuPrænatal depression | Mental sundhedsrelateret livskvalitet | Mødre postpartum depression | Faders postpartum depressionEtiopien
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Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryAktiv, ikke rekrutterendeDepression | Depression Moderat | Depression Alvorlig | Depression MildForenede Stater
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Fondation FondaMentalGYNOVIkke rekrutterer endnuDepression | Depression hos voksne | Depression lidelseFrankrig
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University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RekrutteringMild depressionForenede Stater
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Massachusetts General HospitalRekrutteringDepression | Depression - svær depressiv lidelse | Depression Kronisk | Depression hos voksne | Depressionslidelser | Depression lidelseForenede Stater
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Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRekrutteringDepression | Depression Moderat | Depression Alvorlig | Depression MildForenede Stater
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University of MinnesotaAfsluttetDepression SymptomerForenede Stater
Kliniske forsøg med adfærdsaktivering
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Lovisenberg Diakonale HospitalOslo Metropolitan UniversityAfsluttet
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Truway Health, Inc.Tilmelding efter invitationStillesiddende adfærd | Sundhedsadfærd | AdfærdsaktiveringForenede Stater
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Boston UniversityUkendtDepressionForenede Stater
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Education University of Hong KongThe University of Hong Kong; Columbia University; The Hong Kong Polytechnic... og andre samarbejdspartnereIkke rekrutterer endnu
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Williams CollegeTemple UniversityAfsluttetFedme | VægttabForenede Stater
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Harvard School of Public Health (HSPH)Africa Academy for Public HealthIkke rekrutterer endnu
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Hospital Clinic of BarcelonaAktiv, ikke rekrutterende
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Lahore University of Management SciencesRekruttering
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Medical University of South CarolinaCVRx, Inc.Trukket tilbageKongestiv hjertesvigtForenede Stater
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Northwestern UniversityAfsluttetDepression | Anhedonia | ManiodepressivForenede Stater