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Internet Intervention for the Prevention of Depression - Approaches to Improving Mood (AIM)

29. Juni 2012 aktualisiert von: David Mohr, Northwestern University

Technology Assisted Behavioral Intervention for the Prevention of Depression

This study will develop and evaluate the effectiveness of a technology-assisted behavioral intervention, consisting of Internet-based cognitive behavioral therapy combined with telephone and email support, in preventing depressive symptoms and improving treatment adherence in individuals at risk of major depressive disorder.

Studienübersicht

Detaillierte Beschreibung

Depression is common, with one-year prevalence rates of major depressive disorder (MDD) estimated to be between 6.6-10.3% in the general population. Depression imposes a very high societal burden in terms of cost, morbidity, suffering, and mortality. Yet only about 20% of all patients referred for psychotherapy ever enter treatment, and of those who initiate treatment, nearly half drop out before completion. Given the limitations of treatment and the significant burden of depression, research into the prevention of depression is needed. There is a dearth of research related to the effective prevention of depression.

Delivering an intervention through telecommunication technologies, such as the telephone and Internet, has the potential to overcome many of the barriers to existing depression prevention interventions. For example, telephone- and Web-based interventions can reduce cost, extend specialized treatment over broad geographic areas, and permit considerable flexibility in scheduling of treatment components. Approaches to Improving Mood (AIM) is a specific form of a telecommunication behavioral intervention that incorporates Web-based Internet, e-mail, and telephone intervention. Further study is needed to determine the effectiveness of AIM in preventing depressive symptoms and improving attrition from treatment rates in people at risk for MDD. The study will compare the effectiveness of the AIM program with a one year surveillance follow up with the effectiveness of the AIM program alone and a website offering information on depression prevention in preventing depressive symptoms and improving treatment adherence in individuals at risk of MDD.

Participation in the treatment phase of this study will last 12 weeks. All participants will first undergo initial assessments that will include a telephone interview and a series of questionnaires about mood. Eligible participants will then be assigned randomly to receive AIM + surveillance, AIM alone, or the education website. All participants will undergo 12 weeks of a Web-based Internet intervention consisting of modules to help them learn skills to manage their moods. Participants will be asked to access the Web site every day or two to complete the modules and to practice the learned techniques. Participants assigned to AIM + surveillance and AIM alone will also receive a weekly telephone-based motivational intervention from a coach and will be able to communicate with the coach via email throughout the first 12 weeks of treatment. Participants assigned to the education group will be given access to a website but no assistance from a coach. All participants will undergo repeat initial assessments at Weeks 6, 12 (end of treatment) and at 3 months, 6 months, 9 months and 12 months following the completion of treatment.

Studientyp

Interventionell

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Northwestern University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

19 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • PredictD Risk Score of .130
  • Has a telephone, e-mail account, computer, and broadband access to the Internet.
  • Is able to speak and read English.
  • Is at least 19 years of age.
  • Is able to give informed consent.

Exclusion Criteria:

  • Has DSM-IV diagnosis of Major Depressive Episode assessed using the MINI
  • Has hearing or voice impairment that would prevent participation in psychotherapy.
  • Has visual impairment that would prevent use of the workbook and completion of assessment materials.
  • Meets criteria for dementia by scoring < 25 on the Telephone Interview for Cognitive Status (TICS).
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous. Patients with substance abuse diagnoses who have been clean and sober for 3 months will be admitted if otherwise eligible.
  • Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 12-week treatment phase of the study.
  • Is planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time.
  • Exhibits severe suicidality, including ideation, plan, and intent.
  • Has initiated treatment with an antidepressant in past 10 days. Once patients have been on a stable dose for 10 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: AIM + surveillance
Participants will receive access to the AIM website and calls from a motivational coach for 12 weeks plus an additional year of surveillance and optional coach support.
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach. Surveillance will consist of monthly screening of depression symptoms and outreach from the coach should there be an increase in symptoms.
Experimental: AIM intervention
Participants will receive access to the AIM web based intervention and calls from a motivational coach for 12 weeks
The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach.
Aktiver Komparator: Educational website
Participants will be given access to a static website with depression prevention related materials and handouts.
Participants will receive access to a static educational website for 12 weeks.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Depression, as assessed by Quick Inventory of Depressive Symptoms (QIDS), the Patient Health Questionnaire-9 (PHQ-9), and the Mini International Neuropsychiatric Interview (MINI) Disorders-Major Depressive Disorders Module
Zeitfenster: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Website utilization (e.g., number of logins, average visit length, total time spent on the site, number of exercises completed), Attrition and cost effectiveness.
Zeitfenster: From baseline through 12 month follow-up
From baseline through 12 month follow-up

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Anxiety, impact on work, social support
Zeitfenster: Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12
Measured at baseline, week 6, week 12 and month 3, month 6, month 9 and month 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: David C. Mohr, Ph.D., Northwestern University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2012

Primärer Abschluss (Voraussichtlich)

1. Dezember 2013

Studienabschluss (Voraussichtlich)

1. Dezember 2013

Studienanmeldedaten

Zuerst eingereicht

2. März 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. März 2010

Zuerst gepostet (Schätzen)

3. März 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

3. Juli 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2012

Zuletzt verifiziert

1. Juni 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • NU IRB STU00020637

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur AIM Web based intervention + surveillance

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