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Priming Attachment Security Within an IAPT Setting

13 luglio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Depressione

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

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.

Contatto studio

Nome: Charlotte Heathcote
Numero di telefono: 07939298922
Email: cheathcote1@sheffield.ac.uk

Luoghi di studio

Regno Unito
- North Yorkshire
  - Harrogate, North Yorkshire, Regno Unito, hg12pw
    - Harrogate IAPT Service

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

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 Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: 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.	Comportamentale: Treatment as Usual (Behavioural Activation) Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.
Sperimentale: 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.	Comportamentale: 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.

Gruppo di partecipanti / Arm

Intervento / Trattamento

Comparatore attivo: 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.

Comportamentale: Treatment as Usual (Behavioural Activation)

Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.

Sperimentale: 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.

Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Attendance Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

University of Sheffield

Investigatori

Investigatore principale: James Walton, Harrogate IAPT Service

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 (Anticipato)

1 agosto 2019

Completamento primario (Anticipato)

1 ottobre 2019

Completamento dello studio (Anticipato)

1 ottobre 2019

Date di iscrizione allo studio

Primo inviato

17 giugno 2019

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2019

Primo Inserito (Effettivo)

17 luglio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

249633

Piano per i dati dei singoli partecipanti (IPD)

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Informazioni su farmaci e dispositivi, documenti di studio

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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

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 .

Priming Attachment Security Within an IAPT Setting