Unipolar DepressionPhase 1NCT01694030
Effects of Repeated Attachment Security Priming on Depressed Mood: a Clinical Study
A Phase 1 study testing Attachment security priming in people with Unipolar Depression, run by University of Southampton at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Attachment security priming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Dec 2014
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Anxiety and depressive symptoms
Who cannot join
- -Bipolar disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
College Keep
Southampton, Hants, SO14 3DT
David Baldwin, D.S.Baldwin@soton.ac.uk
Lorna Otway
About this study
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.
- Conditions
- Unipolar Depression
- Being tested
- Attachment security priming
- Keywords
- Attachment security priming, depressed mood
- Medical subject headings
- Depressive Disorder, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment security primingOther
| Study group | Role | What they receive |
|---|---|---|
| Neutral Condition | Experimental | 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. Receives: Other: Attachment security priming |
| Secure condition | Experimental | 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. Receives: Other: Attachment security priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressed Mood 1
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.
Measured: Depressed mood will be measured on day 7 of the study (immediately after lab primes)
Secondary outcomes (5)
Felt Security 1
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.
Measured: Felt security will be measured on day 7 of the study (after initial lab primes)
Depressed Mood 2
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.
Measured: Depressed mood will be measured on day 7 of the study (after 3 days of text primes)
Depressed Mood 3
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.
Measured: Depressed mood will be measured on day 11 of the study (24 hours after the last text prime).
Felt Security 2
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.
Measured: Felt security will be measured on day 10 of the study (after 3 days of text primes)
Felt Security 3
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.
Measured: Felt security will be measured on day 11 of the study (24 hours after last text prime)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Baldwin, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694030
- Sponsor's protocol ID
- University of Southampton: LO6
- Status last verified
- Sep 2012
- First submitted
- 17 Sep 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repeated Attachment Security Priming on Depressed Mood: a Clinical Study
- ClinicalTrials.gov ID
- NCT01694030
- Acronym / sponsor ID
- University of Southampton: LO6
- Conditions
- Unipolar Depression
- Keywords
- Attachment security priming, depressed mood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Sep 2012 (estimated)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral Condition | Experimental | Other: Attachment security primingParticipants 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. |
| Secure condition | Experimental | Other: Attachment security primingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Anxiety and depressive symptoms
Key exclusion criteria (1 listed)
- -Bipolar disorder
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 |
|---|---|---|
| Attachment security priming | Other | Neutral Condition, Secure condition |
Primary outcome
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.
5 secondary outcomes
Felt Security 1
Time frame: 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 3
Time frame: 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)
Felt Security 3
Time frame: Felt security will be measured on day 11 of the study (24 hours after last text prime)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
Related trials for Unipolar Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
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.
Professor Baldwin principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Attachment security priming in people with Unipolar Depression, run by University of Southampton 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 1 inclusion and 1 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 26 Sep 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lorna Otway (447764985326, Lorna.Otway@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressed Mood 1 (time frame: Depressed mood will be measured on day 7 of the study (immediately after lab primes)). 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 26 Sep 2012.