Clinical trial NCT04022759: Priming Attachment Security Within an IAPT Setting
Official title: Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Attachment
Improving Access to Psychological Therapies
Security priming
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attendance
timeFrame: Up to 8 weeks from the beginning to end of treatment
measure: Dropout
timeFrame: Up to 8 weeks from the beginning to end of treatment
measure: Stepping-up to higher intensity services
timeFrame: Up to 8 weeks from the beginning to end of treatment
Secondary outcomes:
measure: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
timeFrame: Weekly for up to 8 weeks from the beginning to end of treatment
measure: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)
timeFrame: Weekly for up to 8 weeks from the beginning to end of treatment
measure: The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)
timeFrame: Weekly for up to 8 weeks from the beginning to end of treatment
Other outcomes:
Locations:
city: Harrogate
country: United Kingdom
facility: Harrogate IAPT Service
state: North Yorkshire
Study officials:
affiliation: Harrogate IAPT Service
name: James Walton
role: PRINCIPAL_INVESTIGATOR
References: