- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01816204
Therapist Assisted Online Treatment for Anxiety (TAO-anxiety)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participation is restricted to currently enrolled students at the University of Florida who have paid the health fee, and who are seeking treatment for anxiety and the Counseling and Wellness Center. Students who meet criteria and agree to participate will select from two treatments, individual face-to-face or therapist assisted on-line treatment. Prior to each session of individual therapy, or on-line treatment participants will complete the Behavioral Health Measure-20 is a normal part of treatment at the CWC.
If a participant is assigned to the Therapist-assisted on-line (TAO) treatment he/she will be asked to complete a seven module on-line treatment. Each module includes interactive, educational materials and weekly assignments. Subjects may participate in an on-line discussion forum with other participants for each module. The forum will use only first names or a pseudonym to protect confidentiality. In addition, participants in the TAO treatment will receive a 10-20 minute video-conference weekly with a doctoral level therapist. Therapists will review assignments, answer questions, and help to apply the educational materials contained in the modules to the subjects life.
The video conference will be on Adobe Connect. This involves a free download for a computer, tablet, or smart phone. Medical records will be kept for ten years, per UF policy. Adobe connect is HIPAA and HITECH compliant. Research records will be de-identified and use an identifier number that cannot be connected to individual participants.
Only 2 arms were actually used, Face-to-face therapy and TAO treatment.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Florida
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Gainesville, Florida, Forenede Stater, 32611-2662
- Counseling and Wellness Center, University of Florida
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- students,
- mild to moderate anxiety,
- has appropriate computer equipment
Exclusion Criteria:
- Severe depression or anxiety,
- suicidal in past 12 months,
- not stable on medications for at least 30 days prior to beginning study treatments
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Therapist assisted online treatment (TAO)
Students assigned to treatment with weekly online modules and weekly 10-15 minute video conference with counselor.
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7 weekly interactive online modules with 10-15 minute counselor consultation via video conference.
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Aktiv komparator: face-to-face individual therapy
weekly individual 50 minute psychotherapy sessions.
|
weekly individual counseling as usual.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Behavioral Health Measure-20 (BHM-20)
Tidsramme: The three measures will be administered weekly from initial enrollment in the study for 7 weeks and again at 6 month follow up. The first assessment of patients will begin May 7 and will continue through January, 2014.
|
twenty item likert-type measure of distress, well-being, overall mental health functioning.
|
The three measures will be administered weekly from initial enrollment in the study for 7 weeks and again at 6 month follow up. The first assessment of patients will begin May 7 and will continue through January, 2014.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sherry A Benton, Ph.D., University of Florida
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 539-2012
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