Priming Attachment Security Within an IAPT Setting
13 juli 2019 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Yorkshire
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Harrogate, North Yorkshire, Storbritannien, hg12pw
- Harrogate IAPT Service
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
Clients will engage in treatment as usual.
This involves low-intensity guided self-help behavioural activation for depression.
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|
Experimentell: 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.
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Attendance
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Tidsram: 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.
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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)
Tidsram: 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)
Tidsram: 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.
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Weekly for up to 8 weeks from the beginning to end of treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: James Walton, Harrogate IAPT Service
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 augusti 2019
Primärt slutförande (Förväntat)
1 oktober 2019
Avslutad studie (Förväntat)
1 oktober 2019
Studieregistreringsdatum
Först inskickad
17 juni 2019
Först inskickad som uppfyllde QC-kriterierna
13 juli 2019
Första postat (Faktisk)
17 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 juli 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 249633
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