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One-Day Intervention for Depression and Impairment in Migraine Patients (ACT)

20 dicembre 2017 aggiornato da: Lilian Dindo, Baylor College of Medicine
The purpose of this research study is to examine whether a one-day group workshop, integrating principles from Acceptance and Commitment Therapy and Migraine Education, will result in greater improvements in depressive symptoms and functioning impairment in patients with comorbid migraine and depression than a similar one-day group workshop with Migraine Education only.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Adults with comorbid depression and migraine will be randomized to a 1-day (6-hour) workshop of Acceptance and Commitment Training + Migraine Education (ACT-ME) or Migraine Education only (MEO). The intervention delivered to both study arms will be identical except for the addition of the ACT component delivered in the ACT-ME condition, thereby allowing an estimate of the specific additive effect of the psychotherapy. Measures of acceptance and behavioral avoidance, theoretically important mechanisms of change, will be used to test intervention components by examining whether these processes are uniquely affected by the ACT-ME intervention and whether they account for observed treatment effects. The central hypothesis is that the ACT-ME treatment will lead to significantly greater reduction in depression (HRSD) and disability (WHO-DAS, WHOQOL, and HDI) at follow-up compared to the MEO treatment. ACT-ME participants also are expected to demonstrate reductions in behavioral avoidance and enhanced acceptance, which mediate treatment effects. Treatment gains are expected to be maintained through the 6-month follow-up.

Aim 1: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO for treating depression in patients with comorbid depression and migraine.

Hypothesis 1: At 3- and 6-month follow-up, ACT-ME will be more efficacious than MEO as assessed by: 1) a significantly greater decline on the Hamilton Rating Scale for Depression (HRSD) total score; 2) a significantly higher proportion of participants showing 50% or greater decline on the HRSD; and 3) a significantly higher proportion of participants no longer meeting depression criteria on SCID-IV.

Aim 2: To examine the efficacy of a 1-day ACT-ME intervention compared to MEO on functioning in patients with comorbid depression and migraine.

Hypothesis 2: At 3- and 6-month follow-up, compared to the MEO group, participants in the ACT-ME group will exhibit significantly greater improvement in functioning (measured by World Health Organization Disability Assessment Schedule-Total Score; WHO-DAS) and quality of life (measured by World Health Organization Quality of Life Total; WHO-QOL), and greater decline in headache-related disability (measured by Headache Disability Inventory; HDI).

Aim 3: To determine whether changes in acceptance-based coping and behavioral avoidance will mediate the changes in depressive symptoms and disability.

Hypothesis 3: Increases in acceptance-based coping and reductions in behavioral avoidance will mediate relations between treatment group and 1) decline in depressive symptoms as measured by the HRSD and 2) disability, as measured by the WHO-DAS and HDI. Acceptance and Behavioral Avoidance will be measured using the Acceptance and Action Questionnaire and Chronic Pain Acceptance Questionnaire.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

104

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • University of Iowa Carver College of Medicine Department of Psychiatry

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Ages 18-65
  • Current major depressive episode on the SCID-IV (46)
  • Score of ≥ 17 on the HRSD (47)
  • Confirmation of diagnosis of migraine from medical record
  • 4-12 migraines in the previous month

Exclusion Criteria:

  • Bipolar, psychotic, or current substance use disorders
  • History of brain injury
  • Imminent suicidality.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ACT-ME
ACT-ME is designed to reduce behavioral avoidance and to enhance acceptance-based coping. It includes: 1) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 2) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations; and 3) Migraine education whereby each of the educational topics listed below will be covered without detailed discussion of the topics.
Comportamentale: ACT-ME
1 hour discussion about migraine education (ME) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). Migraine education covers topics including migraine symptoms, triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.
Altri nomi:
  • Acceptance and Commitment Training Plus Migraine Education
Sperimentale: Migraine Education Only
The MEO workshop will last six hours and involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine. The group leaders will present one educational topic at a time and the participants will discuss and reflect about issues and experiences related to the topic. If necessary, the group leaders will raise specific discussion questions to facilitate group dialogue and participant involvement. However, information on coping practices will be omitted.
Comportamentale: Migraine Education Only
6 hour discussion of migraine education only (MEO). This will involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine.
Altri nomi:
  • Gestione della malattia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
HRSD
Lasso di tempo: 24 weeks
The HRSD is a structured clinical interview for depression severity. Change from baseline measured at 2, 6, 12, and 24 weeks post workshop.
24 weeks
SCID-IV
Lasso di tempo: 24 weeks
Semi-structured clinical interview for depression. Change from baseline measured at 12 and 24 weeks post workshop.
24 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
WHO-DAS-II
Lasso di tempo: 24 weeks
This is a self-report questionnaire that measures difficulties due to physical and mental health conditions. Measure change from baseline at 12 and 24 weeks post-workshop.
24 weeks
WHO-QOL
Lasso di tempo: 24 weeks
The WHO-QOL is a self-report measure that assesses four domains of quality of life: physical health, psychological well-being, social relationships, and environment. Measure change from baseline at 12 and 24 weeks post workshop.
24 weeks
HDI
Lasso di tempo: 24 weeks
The HDI is a self-report measure that assesses the burden of headaches through perceived impact of headaches on functioning. Measure changes from baseline at 12 and 24 weeks post workshop.
24 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
AAQ-II
Lasso di tempo: 24 weeks
The AAQ-II is a self-report measure that assesses experiential avoidance, or the tendency to avoid unwanted internal experiences (e.g., "I try hard to avoid feeling depressed or anxious"), as well as acceptance, the term used to describe the counter process (e.g., "My thoughts and feelings do not get in the way of how I want to live my life"). Measure changes from baseline at 2, 6, 12, and 24 weeks post workshop.
24 weeks
CPAQ
Lasso di tempo: 24 weeks
The CPAQ is a self-report measure that assesses Activity Engagement, the degree to which one engages in life activities regardless of pain, and Pain Willingness, the willingness to have pain without trying to avoid or reduce it. Measure change from baseline at 2, 6, 12, and 24 weeks post workshop.
24 weeks
Demographics Questionnaire
Lasso di tempo: 1 day
The following information will be obtained: age, ethnicity, marital status, educational level, household income, occupation, current mental health treatment, current medication, number of migraines in previous month, and age of onset of migraine. Information will only be obtained at initial meeting.
1 day
Treatment Questionnaire
Lasso di tempo: 24 weeks
Changes in medications and involvement in psychotherapy/counseling will be documented at each contact and will be confirmed by reviewing medical and pharmacy records. Measured at baseline and 2, 6, 12, and 24 weeks post workshop.
24 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Baylor College of Medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2013

Completamento primario (Effettivo)

1 settembre 2017

Completamento dello studio (Effettivo)

1 settembre 2017

Date di iscrizione allo studio

Primo inviato

28 marzo 2014

Primo inviato che soddisfa i criteri di controllo qualità

4 aprile 2014

Primo Inserito (Stima)

9 aprile 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 dicembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 dicembre 2017

Ultimo verificato

1 dicembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 201301712

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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