Priming Attachment Security Within an IAPT Setting

Not Applicable

• Conditions: Depression

• Registration Number: NCT04022759
• Lead Sponsor: University of Sheffield

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.

Study Timeline

• Study First Submitted: 2019-06-17
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-13
• Last Update Submitted: 2019-07-13
• Study First Posted: 2019-07-17
• Last Update Posted: 2019-07-17
• Study Start: 2019-08-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dropout	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
Stepping-up to higher intensity services	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
Attendance	Up to 8 weeks from the beginning to end of treatment	Number of therapy appointments booked versus number attended for each participant

Secondary Outcome Measures

Name	Time	Method
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)	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.
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)	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.
The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)	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.

Trial Locations

Locations (1)

Harrogate IAPT Service; 🇬🇧 Harrogate, North Yorkshire, United Kingdom