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Priming Attachment Security Within an IAPT Setting

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Treatment as Usual with Security Prime
Treatment as Usual (Behavioural Activation)
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Attachment, Improving Access to Psychological Therapies, Security priming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Harrogate IAPT Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual

Treatment with Security Prime

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Attendance
Number of therapy appointments booked versus number attended for each participant
Dropout
Number of participants who drop out of therapy after attending at least one session 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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 17, 2019
Last Updated
July 13, 2019
Sponsor
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT04022759
Brief Title
Priming Attachment Security Within an IAPT Setting
Official Title
Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Attachment, Improving Access to Psychological Therapies, Security priming

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service.
Arm Title
Treatment with Security Prime
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual with Security Prime
Intervention Description
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
Intervention Name(s)
Treatment as Usual (Behavioural Activation)
Intervention Description
Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.
Primary Outcome Measure Information:
Title
Attendance
Description
Number of therapy appointments booked versus number attended for each participant
Time Frame
Up to 8 weeks from the beginning to end of treatment
Title
Dropout
Description
Number of participants who drop out of therapy after attending at least one session of treatment
Time Frame
Up to 8 weeks from the beginning to end of treatment
Title
Stepping-up to higher intensity services
Description
The number of participants in the study who are referred for a higher intensity form of therapy during their low-intensity therapy
Time Frame
Up to 8 weeks from the beginning to end of treatment
Secondary Outcome Measure Information:
Title
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Description
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.
Time Frame
Weekly for up to 8 weeks from the beginning to end of treatment
Title
The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams, & Lower, 2006)
Description
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.
Time Frame
Weekly for up to 8 weeks from the beginning to end of treatment
Title
The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)
Description
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.
Time Frame
Weekly for up to 8 weeks from the beginning to end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Heathcote
Phone
07939298922
Email
cheathcote1@sheffield.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Amrit Sinha
Phone
0114 2226650
Email
a.sinha@sheffield.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Walton
Organizational Affiliation
Harrogate IAPT Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harrogate IAPT Service
City
Harrogate
State/Province
North Yorkshire
ZIP/Postal Code
hg12pw
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Walton
Phone
01423852137
Email
james.walton2@nhs.net
First Name & Middle Initial & Last Name & Degree
Alison Hobbs
Phone
01423 852137
Email
alison.hobbs1@nhs.net
First Name & Middle Initial & Last Name & Degree
James Walton

12. IPD Sharing Statement

Plan to Share IPD
No

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Priming Attachment Security Within an IAPT Setting

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