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Priming Attachment Security Within an IAPT Setting

13. juli 2019 oppdatert av: Charlotte Heathcote, University of Sheffield

Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study

There is growing evidence that priming attachment security is associated with improved attitudes towards therapy, increased engagement and decreased levels of depression and anxiety. Within the Improving Access to Psychological Therapies (IAPT) programme a consistent problem has been identified of high dropout rates at step 2 services (i.e. where mild to moderate anxious and depressed patients receive guided self-help interventions). The current study incorporates a feasibility and pilot design. The feasibility element will explore issues related to study design to determine suitability for conducting a future randomised control trial (RCT). The pilot study will look at the processes outlined in the protocol to determine whether the study components all work together. Moreover, it will preliminarily aim to explore the effectiveness of the attachment security priming intervention on symptoms of depression and anxiety, as well as impaired functioning. Both elements of the study will determine whether any changes are needed to the study design or protocol, and whether a future RCT is suitable and necessary.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study is being conducted in an IAPT primary care service in North Yorkshire. The study will be recruiting 50 participants experiencing mild to moderate depression who are deemed suitable for 'behavioural activation' low intensity guided self-help intervention. Following telephone screening for intervention, clinicians will ask clients if they wish to hear more about participating in a research study. If participants say yes, their contact details will be passed on to the researcher who will send them the study information sheet and consent form in the post. If the participant consents to taking part in the research, they will be randomised to receive either treatment as usual (low-intensity guided self-help utilising behavioural activation for depression) or treatment with security priming intervention (treatment as usual with an additional security priming task). They will have between 6-8 sessions as routinely delivered within the service and will be asked to complete measures of depression, anxiety and impaired functioning on a sessional basis. The principal investigator at the study site will collect information regarding attendance to therapy, dropout rates, and 'stepping' clients up to higher-intensity therapies as primary outcomes.

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • North Yorkshire
      • Harrogate, North Yorkshire, Storbritannia, hg12pw
        • Harrogate IAPT Service

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
  • Over age 18.
  • Adequate English ability.

Exclusion Criteria:

  • Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
  • Inadequate English ability.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Treatment as Usual
Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service.
Atferdsmessig: Treatment as Usual (Behavioural Activation)
Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.
Eksperimentell: Treatment with Security Prime
Participants randomised to the experimental group will receive behavioural activation guided self-help intervention as is routinely delivered in the service with additional attachment security priming intervention.
Atferdsmessig: Treatment as Usual with Security Prime

In addition to their treatment as usual (low-intensity guided self-help behavioural activation for depression), participants will complete an initial attachment security priming task during the first session with their allocated clinician. Participants will be prompted in their intervention workbook with a caption regarding what a secure attachment relationship represents. They will be asked to think of a person/ people with whom they feel they have this relationship, and list them. Following this, they are asked to plot these individuals on a diagram of concentric circles in relation to how close they feel this person is to them. The closer to the middle of the diagram the individual places each person, the closer they feel their relationship to that person is.

Prior to each session with their clinician, they will be prompted to complete a repeated security priming task in order to increase feelings of security prior to therapy sessions.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Attendance
Tidsramme: Up to 8 weeks from the beginning to end of treatment
Number of therapy appointments booked versus number attended for each participant
Up to 8 weeks from the beginning to end of treatment
Dropout
Tidsramme: Up to 8 weeks from the beginning to end of treatment
Number of participants who drop out of therapy after attending at least one session of treatment
Up to 8 weeks from the beginning to end of treatment
Stepping-up to higher intensity services
Tidsramme: Up to 8 weeks from the beginning to end of treatment
The number of participants in the study who are referred for a higher intensity form of therapy during their low-intensity therapy
Up to 8 weeks from the beginning to end of treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Tidsramme: Weekly for up to 8 weeks from the beginning to end of treatment
Self-report measure of depression with total possible score ranging from 0 to 27. Scores of 0-4 indicate minimal depression; 5-9 indicates mild depression; 10-14 indicates moderate depression; 15-19 indicates moderately severe depression; and 20-17 indicates severe depression.
Weekly for up to 8 weeks from the beginning to end of treatment
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)
Tidsramme: Weekly for up to 8 weeks from the beginning to end of treatment
Self-report measure of anxiety with total possible scores between 0 to 21. Scores of 0-5 indicate mild anxiety; 6-10 indicates moderate anxiety; 11-15 indicates moderately severe anxiety; and 16-20 indicates severe anxiety.
Weekly for up to 8 weeks from the beginning to end of treatment
The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)
Tidsramme: Weekly for up to 8 weeks from the beginning to end of treatment
Self-report measure of impaired functioning with total possible scores of between 0-20. Scores below 10 are associated with subclinical populations. Scores between 10 and 20 indicate significant functional impairment but less severe clinical symptomatology. Scores above 20 indicate moderately severe or worse psychopathology.
Weekly for up to 8 weeks from the beginning to end of treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sheffield

Etterforskere

  • Hovedetterforsker: James Walton, Harrogate IAPT Service

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. august 2019

Primær fullføring (Forventet)

1. oktober 2019

Studiet fullført (Forventet)

1. oktober 2019

Datoer for studieregistrering

Først innsendt

17. juni 2019

Først innsendt som oppfylte QC-kriteriene

13. juli 2019

Først lagt ut (Faktiske)

17. juli 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 249633

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Nei

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