DepressionNCT04022759
Priming Attachment Security Within an IAPT Setting
A study testing Treatment as Usual with Security Prime and Treatment as Usual (Behavioural Activation) in people with Depression, run by University of Sheffield at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Treatment as Usual with Security Prime and Treatment as Usual (Behavioural Activation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Over age 18.
- Adequate English ability.
Who cannot join
- Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Inadequate English ability.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Harrogate IAPT Service
Harrogate, North Yorkshire, hg12pw
James Walton, 01423852137, james.walton2@nhs.net
Alison Hobbs, 01423 852137, alison.hobbs1@nhs.net
About this study
Official title: Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Treatment as Usual with Security Prime, Treatment as Usual (Behavioural Activation)
- Keywords
- Attachment, Improving Access to Psychological Therapies, Security priming
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as Usual with Security PrimeBehavioural
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)Behavioural
Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual with Security Prime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
Number of therapy appointments booked versus number attended for each participant
Measured: 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
Measured: 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
Measured: 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)
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.
Measured: 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)
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.
Measured: Weekly for up to 8 weeks from the beginning to end of treatment
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.
Measured: Weekly for up to 8 weeks from the beginning to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Heathcote, University of Sheffield
- Investigators
- James Walton, Principal investigator, Harrogate IAPT Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022759
- Sponsor's protocol ID
- 249633
- Status last verified
- Jul 2019
- First submitted
- 17 Jun 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming Attachment Security Within an IAPT Setting: A Feasibility and Pilot Study
- ClinicalTrials.gov ID
- NCT04022759
- Acronym / sponsor ID
- 249633
- Conditions
- Depression
- Keywords
- Attachment, Improving Access to Psychological Therapies, Security priming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: Treatment as Usual (Behavioural Activation)Participants randomised to the 'treatment as usual' group will receive behavioural activation guided-self help intervention as routinely delivered in the service. |
| Treatment with Security Prime | Experimental | Behavioral: Treatment as Usual with Security PrimeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Accepted for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Over age 18.
- Adequate English ability.
Key exclusion criteria (2 listed)
- Not suitable for Behavioural Activation guided self-help intervention for depression with study NHS IAPT site.
- Inadequate English ability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as Usual with Security PrimeIn 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. | Behavioural | Treatment with Security Prime |
| Treatment as Usual (Behavioural Activation)Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression. | Behavioural | Treatment as Usual |
Primary outcome
Attendance
Time frame: Up to 8 weeks from the beginning to end of treatment
Number of therapy appointments booked versus number attended for each participant
Dropout
Time frame: 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
Time frame: 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
3 secondary outcomes
The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
Time frame: 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)
Time frame: Weekly for up to 8 weeks from the beginning to end of treatment
The Work and Social Adjustment Scale (WSAS; Mundt, Shear, & Greist, 2002)
Time frame: Weekly for up to 8 weeks from the beginning to end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Walton principal investigator
Harrogate IAPT Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as Usual with Security Prime and Treatment as Usual (Behavioural Activation) in people with Depression, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Heathcote (07939298922, cheathcote1@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: Up to 8 weeks from the beginning to end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.