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Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

25. april 2012 opdateret af: Aude Henin, Massachusetts General Hospital

Reducing High-Risk Behaviors Among Bipolar Patients Transitioning to Adulthood

The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. The intervention also focuses on issues specific to transition-age youth. The study includes two phases: In phase 1, the intervention will be developed, refined, and openly piloted with several participants. In phase 2,the investigators will conduct a randomized clinical trial, in which 40 participants will be randomized either to receive the intervention right away, or to a 14-week waitlist condition. Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period, as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors, drug and alcohol use, and psychosocial functioning.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital

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 24 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosis of bipolar spectrum disorder (Bipolar I, Bipolar II, or Bipolar NOS Disorder)
  • ages 18-24 years
  • able to understand the nature of the study as well as potential risks and benefits
  • in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed.

Exclusion Criteria:

  • concurrent cognitive-behavioral psychotherapy
  • documented mental retardation
  • pervasive developmental disorder
  • current serious medical illness
  • inability to participate in the intervention because of acuity of symptoms
  • current drug or alcohol dependence (other than marijuana dependence)

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CBT
14-week individual cognitive-behavior therapy
Adfærdsmæssigt: cognitive-behavior therapy (CBT)
14 sessions of individual cognitive-behavior therapy. Sessions last 50-60 minutes and are held weekly. 2 optional monthly booster sessions may also be held after the end of treatment.
Ingen indgriben: Treatment As Usual
14-week waitlist control

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Global Improvement Scale (CGI)-Improvement
Tidsramme: week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-rated change in mood symptoms and overall functioning
week 5, week 10, week 14, 3 mo fu, 6 mo fu
feasibility and acceptability
Tidsramme: post-treatment
We will assess the percentage of completers versus drop-outs to examine feasibility of treatment procedures
post-treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adapted Y-BOCS
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
a version of the Yale-Brown Obsessive-Compulsive Scale that has been adapted to assess involvement in high-risk behaviors. This measure is individualized for each participant to assess their specific high-risk behavior that they would like to work on in treatment
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Social Adjustment Scale (SAS)
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses social, educational, occupational, and family functioning
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Timeline Follow-Back
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses alcohol and drug use over the past 30 days.
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
SCID depression and mania modules
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-administered measure that assesses the presence and severity of depression and mania over the past month.
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Medication history and adherence
Tidsramme: baseline, post-treatment, 6 month follow-up
Assesses treatment with different classes of medication, psychotherapy, and psychiatric hospitalization
baseline, post-treatment, 6 month follow-up
Adult Suicidal Ideation Questionnaire (ASIQ)
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses severity of suicidal thoughts and behaviors
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
High-Risk Sexual Behaviors
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Beck Hopelessness Scale
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Barratt Impulsiveness Scale
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Self-Control Behavior Schedule
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Assesses learned resourcefulness and self-control behaviors including problem-solving skills and self-efficacy
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Hamilton Depression Scale (HAM-D)
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-administered measure that assesses severity of depressive symptoms over the past week
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Young Mania Rating Scale
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Clinician-administered measure that assesses severity of manic symptoms over the past week.
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
Treatment Satisfaction Questionnaire
Tidsramme: post-treatment
Assesses participants' satisfaction with the treatment received
post-treatment
Urine Toxicology Screen
Tidsramme: baseline, post-treatment, 6 mo follow-up
baseline, post-treatment, 6 mo follow-up
Risky Driving Inventory
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
South Oaks Gambling Screen
Tidsramme: baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu
baseline, week 5, week 10, week 14, 3 mo fu, 6 mo fu

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: Aude Henin, Ph.D., Massachusetts General Hospital

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. september 2007

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. november 2011

Datoer for studieregistrering

Først indsendt

5. august 2010

Først indsendt, der opfyldte QC-kriterier

5. august 2010

Først opslået (Skøn)

6. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. april 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. april 2012

Sidst verificeret

1. april 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R34MH081335 (U.S. NIH-bevilling/kontrakt)

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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Kliniske forsøg med cognitive-behavior therapy (CBT)

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