Effects of Repeated Attachment Security Priming on Depressed Mood: a Clinical Study

September 24, 2012 updated by: University of Southampton
The purpose of this study is to explore whether asking participants to visualise a secure attachment figure or a neutral event leads to differences in self-reported felt security or depressed mood. Furthermore, the investigators aim to explore whether it is possible to keep a secure prime activated over 3 days via text message visualisation tasks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Hants
      • Southampton, Hants, United Kingdom, SO14 3DT
        • College Keep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Anxiety and depressive symptoms

Exclusion Criteria:

-Bipolar disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neutral Condition
Participants in the neutral (control) condition of the attachment security priming experiment will be asked to spend time visualising neutral events (e.g., supermarket shopping)for 3-10 minutes at a time.
Other: Attachment security priming
Experimental: Secure condition
Participants in the attachment security priming condition will be asked to complete visualisation tasks where they think about a secure attachment figure for between 3 - 10 minutes.
Other: Attachment security priming

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depressed Mood 1
Time Frame: Depressed mood will be measured on day 7 of the study (immediately after lab primes)
Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, & Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.
Depressed mood will be measured on day 7 of the study (immediately after lab primes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Felt Security 1
Time Frame: Felt security will be measured on day 7 of the study (after initial lab primes)
To find out whether the experimental manipulation was successful, participants will complete a 16-item measure of Felt Security (Luke, Carnelley, & Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.
Felt security will be measured on day 7 of the study (after initial lab primes)
Depressed Mood 2
Time Frame: Depressed mood will be measured on day 7 of the study (after 3 days of text primes)
Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, & Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.
Depressed mood will be measured on day 7 of the study (after 3 days of text primes)
Depressed Mood 3
Time Frame: Depressed mood will be measured on day 11 of the study (24 hours after the last text prime).
Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, & Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.
Depressed mood will be measured on day 11 of the study (24 hours after the last text prime).
Felt Security 2
Time Frame: Felt security will be measured on day 10 of the study (after 3 days of text primes)
Participants will complete a 16-item measure of Felt Security (Luke, Carnelley, & Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.
Felt security will be measured on day 10 of the study (after 3 days of text primes)
Felt Security 3
Time Frame: Felt security will be measured on day 11 of the study (24 hours after last text prime)
To find out whether the experimental manipulation was successful, participants will complete a 16-item measure of Felt Security (Luke, Carnelley, & Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.
Felt security will be measured on day 11 of the study (24 hours after last text prime)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southampton

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Professor Baldwin, University of Southampton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • University of Southampton: LO6

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