- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00951340
Desensitization and Cognitive Therapy in General Anxiety.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal functioning. Some research has shown cognitive behavioral therapy (CBT) as an effective treatment for GAD, but only half of people treated with CBT for GAD experience treatment benefits long-term. Standard CBT for GAD may lose effectiveness over time because it does not address interpersonal and emotional processing problems. This study will determine the safety and feasibility of training therapists to deliver a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing.
Participation in this study will include 14 weekly, 2-hour, individual therapy sessions. During the first hour of each session, all participants will receive standard CBT for GAD. Participants will be randomly assigned to receive one of two therapies during the second hour: training in interpersonal and emotional processing techniques or listening therapy. Participants taking medications will be required to maintain a fixed dosage and keep a daily dairy of medication use, starting 2 weeks before study entry and lasting throughout treatment.
In-depth study assessments will take place at baseline and after completing the 15 weeks of therapy. Assessments will include clinical interviews, self-report questionnaires, and a physiological measurement session. Questions will pertain to anxiety symptoms, self-perceptions, emotional experience, and perceptions of the world. The physiological measurement session will involve recording bodily reactions, including brain waves, heart rate, eye movement, and breathing, while performing simple perceptual tasks. Brief psychological assessments will also follow each hour-long portion of each therapy session. Follow-up assessments conducted 6, 12, and 24 months after completing treatment will involve interviews and questionnaires as well as recording a week's worth of medication diaries.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Pennsylvania
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University Park, Pennsylvania, Vereinigte Staaten, 16802-3103
- The Pennsylvania State University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV and agreed on by two diagnostic interviewers
Exclusion Criteria:
- Concurrent psychosocial therapy or past adequate dosage of CBT
- Medical contributions to anxiety
- Current substance abuse, psychosis, or organic brain syndrome
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: CBT with listening therapy
Participants will receive CBT with listening therapy.
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15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques
Andere Namen:
15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion
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Experimental: CBT with emotional processing and interpersonal therapy
Participants will receive CBT with emotional processing and interpersonal therapy.
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15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques
Andere Namen:
15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Feasibility of delivering emotional processing and interpersonal therapeutic techniques
Zeitfenster: Measured at baseline, post-treatment, and after 6, 12, and 24 months
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Measured at baseline, post-treatment, and after 6, 12, and 24 months
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R01MH039172-02 (US NIH Stipendium/Vertrag)
- 2R01MH039172-12 (US NIH Stipendium/Vertrag)
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