Priming Attachment Security Within an IAPT Setting

Depression Clinical Trial

Official title:

Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04022759
• Other study ID #: 249633
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2019
• Source: University of Sheffield
• Contact: Charlotte Heathcote
• Phone: 07939298922
• Email: cheathcote1[@]sheffield.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• 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.
• Treatment as Usual (Behavioural Activation)
Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.

Locations

Country	Name	City	State
United Kingdom	Harrogate IAPT Service	Harrogate	North Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance	Number of therapy appointments booked versus number attended for each participant	Up to 8 weeks from the beginning to end of treatment
Primary	Dropout	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
Primary	Stepping-up to higher intensity services	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
Secondary	The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)	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
Secondary	The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)	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
Secondary	The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)	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