Priming Attachment Security Within an IAPT Setting

NCT04022759 | Unknown

• 1 other identifier: 249633
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Attachment; Improving Access to Psychological Therapies; Security priming

Outcome Measures

Primary Outcomes (3)

• Attendance

  Number of therapy appointments booked versus number attended for each participant

  Up to 8 weeks from the beginning to end of treatment

• 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

• 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 Outcomes (3)

• The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

  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)

  Weekly for up to 8 weeks from the beginning to end of treatment

• The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)

  Weekly for up to 8 weeks from the beginning to end of treatment

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service.

Behavioral: Treatment as Usual (Behavioural Activation)

Treatment with Security Prime

EXPERIMENTAL

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.

Behavioral: Treatment as Usual with Security Prime

Interventions

Treatment as Usual with Security Prime 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.

Treatment with Security Prime

Treatment as Usual (Behavioural Activation) BEHAVIORAL

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

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
• Over age 18.
• Adequate English ability.

You may not qualify if:

• Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
• Inadequate English ability.

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

Harrogate IAPT Service

Harrogate, North Yorkshire, hg12pw, United Kingdom

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• James Walton

  Harrogate IAPT Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Heathcote

CONTACT

07939298922; cheathcote1@sheffield.ac.uk

Amrit Sinha

CONTACT

0114 2226650; a.sinha@sheffield.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: July 17, 2019
• Study Start: August 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)