Priming Attachment Security Within an IAPT Setting

NCT ID: NCT04022759

Last Updated: 2019-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The feasibility element of the study will aim to explore service users' willingness to participate in the study; clinician's willingness to recruit participants; whether the recruitment method is effective in recruiting participants; and to assess attrition rates.

The pilot study aims to look at the processes involved in the study as outlined in the protocol, and whether any of these require changes to inform a larger scale RCT; this includes whether the recruitment, randomisation and treatment processes can be carried out effectively. Moreover, the study aims to determine whether the attachment security priming intervention appears to be effective in reducing therapy drop-out; increasing attendance to therapy; and decreasing rates of clients' being stepped-up to step 3 high-intensity services. Secondary to this, the study aims to assess whether priming attachment security appears to have an impact upon levels of depression, anxiety and impaired functioning.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The participant will not explicitly be told which condition they are in by the researcher or the clinician working directly with them. However, they are likely to be able to infer this from the treatment being delivered, having read the information sheet regarding the study. The clinician working with the participant will be aware what condition they are in so that they are able to deliver the appropriate intervention.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual (Behavioural Activation)

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Treatment as Usual with Security Prime

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Treatment as Usual (Behavioural Activation)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sheffield

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Heathcote

Trainee Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Walton

Role: PRINCIPAL_INVESTIGATOR

Harrogate IAPT Service

Locations

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Harrogate IAPT Service

Harrogate, North Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Charlotte Heathcote

Role: CONTACT

07939298922

Amrit Sinha

Role: CONTACT

0114 2226650

Facility Contacts

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James Walton

Role: primary

01423852137

Alison Hobbs

Role: backup

01423 852137

Other Identifiers

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249633

Identifier Type: -

Identifier Source: org_study_id

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