- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01532219
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders (ATLAS)
23. april 2013 opdateret af: Gerhard Andersson, Linkoeping University
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders: A Randomized Controlled Trial
The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with major depression and/or anxiety disorders and compare its efficacy to an active control group.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
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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Linköping, Sverige, 58183
- Linköping University, Department of Behavioral Sciences and Learning
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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 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of Major Depressive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety disorder, Depressive Disorder NOS or Anxiety Disorder NOS
- 10 or higher on the PHQ-9 or on the GAD-7 at pre-treatment
Exclusion Criteria:
- Primary diagnosis of Obsessive Compulsive Disorder or Post-traumatic Stress Disorder
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Alcohol abuse (more than 16 on the AUDIT)
- Suicidal (measured in diagnostic interview)
- Changed medication during the last three months
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Internet-delivered Psychodynamic Treatment
Participants in the experimental condition will receive 8 text-modules delivered as guided self-help, via the Internet.
The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail.
The treatment is a short-term psychodynamic treatment psychodynamic treatment.
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Ten weeks of guided self-help + therapist contact, via the Internet.
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Aktiv komparator: Internet-delivered structured support
Participants in the active control condition will receive a structured support treatment via the Internet.
The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail.
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Ten weeks of therapist contact, via the Internet.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Tidsramme: Two weeks before the treatment starts
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Two weeks before the treatment starts
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Tidsramme: Two weeks before the treatment starts
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Two weeks before the treatment starts
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9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Tidsramme: At treatment start (0 weeks)
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At treatment start (0 weeks)
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Tidsramme: At treatment start (0 weeks)
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At treatment start (0 weeks)
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9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Tidsramme: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Tidsramme: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Tidsramme: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
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7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Tidsramme: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Emotional Processing Scale (EPS-25)
Tidsramme: Two weeks before the treatment starts
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Two weeks before the treatment starts
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Emotional Processing Scale (EPS-25)
Tidsramme: At treatment start (0 weeks)
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At treatment start (0 weeks)
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Emotional Processing Scale (EPS-25)
Tidsramme: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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Five Facets of Mindfulness Questionnaire (FFMQ)
Tidsramme: Two weeks before the treatment starts
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Two weeks before the treatment starts
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Five Facets of Mindfulness Questionnaire (FFMQ)
Tidsramme: At treatment start (0 weeks)
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At treatment start (0 weeks)
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Five Facets of Mindfulness Questionnaire (FFMQ)
Tidsramme: At treatment termination (10 weeks)
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At treatment termination (10 weeks)
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Emotional Processing Scale (EPS-25)
Tidsramme: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
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Five Facets of Mindfulness Questionnaire (FFMQ)
Tidsramme: At treatment follow-up (7 months)
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At treatment follow-up (7 months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. februar 2012
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
9. februar 2012
Først indsendt, der opfyldte QC-kriterier
9. februar 2012
Først opslået (Skøn)
14. februar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. april 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. april 2013
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GA-DEPANX2012-APT
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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