Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000942853
Ethics application status
Approved
Date submitted
1/06/2021
Date registered
19/07/2021
Date last updated
27/09/2021
Date data sharing statement initially provided
19/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating whether a mindfulness intervention buffers the links between attachment insecurity and negative relationship outcomes

Scientific title
Evaluating whether a brief mindfulness intervention buffers the links between attachment insecurity and negative relationship and sexual outcomes in healthy adults: A randomised controlled trial
Secondary ID [1] 304375 0
Nil
Universal Trial Number (UTN)
Trial acronym
MiRIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attachment anxiety
 322165 0
Attachment avoidance 322166 0
Condition category
Condition code
Mental Health 319855 319855 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will participate in a 4-week mindfulness intervention. This will involve listening to 10-minute audio-guided exercises every day for 4 weeks. Exercises consist of the following components: (1) practical instructions about posture, (2) short grounding in present moment experiences by paying attention to posture and the breath, (3) directing of attention towards experiences (thoughts, emotions, and bodily sensations), (4) instruction to develop an attitude of non-judgment and acceptance toward experiences, and (5) instructions to carry this quality of awareness into interpersonal interactions with others and especially a romantic partner.

Over the course of the 4 weeks, participants will be offered 4 different versions of this exercise – with each recording differing slightly in wording (i.e. on Day 1 of the intervention, participants will receive Version 1 of the recording, Day 2 = Version 2, Day 3 = Version 3, Day 4 = Version 4, Day 5 = Version 1, Day 6 = Version 2, Day 7 = Version 3, etc). Participants will not be able to choose which version they would prefer to receive throughout the intervention.

To monitor adherence, participants will be asked to report whether they listened to the audio recording each day.

Recordings will be hosted on REDcap. Links to the recordings will be delivered via text or email to participants early each morning. If participants have not completed the activity by 7.30pm that evening, participants will be sent a reminder to listen to the recording. The recordings will be done via a PhD candidate who is also undergoing training to teach the 8-week Mindfulness-Based Stress Reduction programme.
Intervention code [1] 320739 0
Behaviour
Intervention code [2] 320740 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327724 0
Daily conflict or disagreement with a partner (the items to be used are outlined in Dixon & Overall, 2018 and Overall, Girme, Lemay Jr, & Hammond, 2014).
Timepoint [1] 327724 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Primary outcome [2] 327726 0
Daily Negative Interaction Behaviour (composite variable evaluated using items outlined in Overall & Sibley 2009)
Timepoint [2] 327726 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Primary outcome [3] 327728 0
Daily sexual motivations assessed using a scale adapted from Cooper, Shapiro, and Powers (1998) and previously used by Impett and colleagues (2005; 2008; 2013).
Timepoint [3] 327728 0
Assessment of this outcome will be done everyday participants report being motivated to have sex for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [1] 396362 0
Daily positive relationship-promotive behaviours (composite variable evaluated using items from Overall & Sibley 2009 and Murray et al 2003)
Timepoint [1] 396362 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [2] 396365 0
Daily self-control as assessed using an item previously used in a daily diary study (see the item listed in this OSF pre-registered study: https://osf.io/yzfrs/?view_only=7eedabb30331418bad30c5ff88033a0a)
Timepoint [2] 396365 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days directly after completion of the 4-week intervention
Secondary outcome [3] 396366 0
Daily sexual experience as assessed with items previously used in daily diary studies (e.g., Impett et al, 2008; Muise et al, 2017).
Timepoint [3] 396366 0
Assessment of this outcome will be done on the days participants report having sex across the 7-day period pre-intervention and the 7-day period directly after completion of the 4-week intervention
Secondary outcome [4] 396367 0
Daily Perceptions of Partner’s Negative Interaction Behaviour (composite variable evaluated using items based on items listed in Overall & Sibley 2009)
Timepoint [4] 396367 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [5] 396373 0
Attachment orientation as assessed by the Experiences in Close Relationships – Revised Scale (Fraley, Waller, & Brennan, 2000)
Timepoint [5] 396373 0
Assessed at baseline (i.e. before the pre-intervention 7-day daily diary, and before the 4-week intervention) and after completion of the 4-week intervention and post-intervention 7-day daily diary
Secondary outcome [6] 397411 0
Daily Guilt-Induction Behaviour using a single item designed for this study
Timepoint [6] 397411 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [7] 397412 0
Daily Reassurance Seeking using a two items from unpublished research from Overall and colleagues (e.g., “I sought reassurance as to whether my partner really cared about me”)
Timepoint [7] 397412 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [8] 397413 0
Daily perceived regard and intimacy (composite variable assessed using five items based on items from Overall & Sibley 2009, Murray et al 2003, and unpublished research from Overall and colleagues)
Timepoint [8] 397413 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [9] 397415 0
Daily Rejection Fears (primary outcome) as assessed using an item outlined in Dixon & Overall, 2018.
Timepoint [9] 397415 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [10] 397417 0
Daily relationship worries assessed using two items from unpublished research from Overall and colleagues (e.g., “I felt insecure about my relationship with my partner”)
Timepoint [10] 397417 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [11] 397421 0
Daily sexual desire using a single item designed for this study
Timepoint [11] 397421 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [12] 397424 0
Attachment behaviours as assessed using the Brief Accessibility, Responsiveness, and Engagement Scale (Sandberg et al 2012) (primary outcome)
Timepoint [12] 397424 0
Assessed at baseline (i.e. before the pre-intervention 7-day daily diary, and before the 4-week intervention) and after completion of the 4-week intervention and 7-day post-intervention daily diary
Secondary outcome [13] 397654 0
Daily inattentiveness/unresponsiveness assessed using a single item from unpublished research from Overall and colleagues (“I was inattentive and unresponsive to my partner”)
Timepoint [13] 397654 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [14] 397655 0
Daily perceptions of partner’s inattentiveness/unresponsiveness assessed using a single item from unpublished research from Overall and colleagues (“My partner was inattentive and unresponsive to me”)
Timepoint [14] 397655 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [15] 397656 0
Daily perceptions of partner’s affectionate behaviour assessed using a single item from unpublished research from Overall and colleagues
Timepoint [15] 397656 0
Assessment of this outcome will be done every day for 7-days pre-intervention and every day for 7-days after completion of the 4-week intervention
Secondary outcome [16] 397657 0
Daily sexual communal motivation will be assessed with 3 items previously used in daily diary studies (Muise et al., 2017, 2018, 2019). These three items are from a validated scale ("Sexual Communal Strength Scale"; Muise et al., 2013).
Timepoint [16] 397657 0
Assessment of this outcome will be done on the days participants report having sex across the 7-day period pre-intervention and the 7-day period directly after completion of the 4-week intervention
Secondary outcome [17] 397658 0
Daily unmitigated sexual communal motivation will be assessed with 3 items previously used in daily diary studies (Impett et al., 2017, 2018, 2019). These three items are from a previously validated scale ("Unmitigated Communion Scale"; Hegelson, 1993).
Timepoint [17] 397658 0
Assessment of this outcome will be done on the days participants report having sex across the 7-day period pre-intervention and the 7-day period directly after completion of the 4-week intervention

Eligibility
Key inclusion criteria
Participants need to be over 18 years of age, a resident in NZ, fluent in English, have a smartphone, be in a romantic relationship lasting at least a year, and be living together with their partner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If participants are currently undergoing relationship therapy they will not be eligible for the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A - No allocation is done as this is not an RCT.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A - No allocation is done as this is not an RCT.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
First, data will be screened for errors, baseline differences, outliers, and evidence for the violation of parametric assumptions. Data from measures collected daily in the pre-intervention period will be aggregated to form pre-intervention scores of outcome variables (e.g., conflict behaviours). The same will be done for data from measures collected in the post-intervention period. Correlations will be conducted to characterise univariate relationships between study variables. An initial t-test will investigate whether the mindfulness intervention led to the expected changes in relationship outcomes (e.g., conflict behaviours). Next, our primary analysis, a 2(time) x (attachment anxiety) ANOVA, will test whether any benefits associated with the mindfulness intervention are comparably evidenced at high versus low attachment anxiety. Identical analyses replacing attachment anxiety with attachment avoidance will test whether any changes in relationship outcomes associated with the mindfulness intervention are comparably evidenced at high versus low attachment avoidance.

Our sample size was determined as follows: As there is no existing research available upon which to estimate an effect size for the main statistical model, we have chosen to power our model to detect a small to medium sized effect. Using G*Power, we calculated that the minimum required sample size to detect a small to medium effect size of f=0.200 using a mixed analysis of variance (ANOVA) including within-subject (2 time points) and between-subject (2 groups) effects with 80% power and at a 2-sided 5% significance level was 200 participants.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/07/2021
Actual
31/07/2021
Date of last participant enrolment
Anticipated
31/08/2021
Actual
5/09/2021
Date of last data collection
Anticipated
17/10/2021
Actual
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 23746 0
New Zealand
State/province [1] 23746 0
Auckland

Funding & Sponsors
Funding source category [1] 308746 0
University
Name [1] 308746 0
University of Auckland
Country [1] 308746 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
NZ
Country
New Zealand
Secondary sponsor category [1] 309646 0
None
Name [1] 309646 0
Address [1] 309646 0
Country [1] 309646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308666 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 308666 0
Ethics committee country [1] 308666 0
New Zealand
Date submitted for ethics approval [1] 308666 0
27/05/2021
Approval date [1] 308666 0
24/06/2021
Ethics approval number [1] 308666 0
UAHPEC22749

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111482 0
Dr Nathan Consedine
Address 111482 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
22-30 Park Avenue, Grafton, Auckland, 1142
Country 111482 0
New Zealand
Phone 111482 0
+64 9 923 5976
Fax 111482 0
Email 111482 0
[email protected]
Contact person for public queries
Name 111483 0
Holly Dixon
Address 111483 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
22-30 Park Avenue, Grafton, Auckland, 1142
Country 111483 0
New Zealand
Phone 111483 0
+64 2102356060
Fax 111483 0
Email 111483 0
[email protected]
Contact person for scientific queries
Name 111484 0
Holly Dixon
Address 111484 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
22-30 Park Avenue, Grafton, Auckland, 1142
Country 111484 0
New Zealand
Phone 111484 0
+64 2102356060
Fax 111484 0
Email 111484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected during the study can be shared with interested international researchers.
When will data be available (start and end dates)?
From immediately after publication, to 5 years after the main results publication.
Available to whom?
International researchers who provide a methodologically sound proposal for secondary data analysis may access de-identified data.
Available for what types of analyses?
Only to achieve the aims in a methodologically sound proposal approved by the named investigators in this clinical trial registration.
How or where can data be obtained?
Access to de-identified data is subject to approval by the PhD student researcher (i.e. the contact person for public and scientific queries, named in this clinical trial registration; [email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.