Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000767808
Ethics application status
Approved
Date submitted
23/04/2021
Date registered
21/06/2021
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Modification of social interpretive bias in young adults
Scientific title
The Effect of a Cognitive Bias Modification-Intervention on Interpretation Bias and suicidal ideation in Young Adults.
Secondary ID [1] 303634 0
Nil known
Universal Trial Number (UTN)
U1111-1265-9184
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 321189 0
Perceived burdensomeness 321190 0
Thwarted belonging 321191 0
Condition category
Condition code
Mental Health 318982 318982 0 0
Suicide
Mental Health 319782 319782 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be undergraduate psychology students from the University of Otago, recruited through the Department of Psychology research participation programme. Participants will be asked to complete three surveys and four intervention sessions across 21 days. Each survey is expected to take approximately 15 minutes to complete and each intervention session is expected to take approximately 10 minutes to complete.

On Day 1, participants will receive the initial invitation to complete the study and will be asked to complete the first survey and first intervention session. At the beginning of the survey, participants will be presented with the information sheet, as well as information about implied consent, continuation with the study implies consent for participation. Following completion of the first survey and intervention session, participants will be asked to complete an additional three 10-minute intervention sessions across one week (Days 3, 5, and 7). The third intervention session will be followed immediately by the post-intervention survey (Day 7). Participants will then be asked to complete the survey again two-weeks later for follow-up (Day 21).

The intervention condition is a Cognitive Bias Modification-Intervention (CBM-I) task. The particular version of this task to be used in the current study is the Sentence Completion Task. This task was developed by Mathews and Mackintosh (2000) to influence the way people interpret ambiguous situations. The task consists of a series of descriptions, each of which are two sentences long. The first sentence is ambiguous, and the second sentence disambiguates the scenario (e.g., “You hear people talking about the speech you gave. They found it int_resting.”). One word in the second sentence is presented as a word fragment (e.g., int_resting) that participants are asked to complete. After the word fragment is completed, participants are presented with a yes/no comprehension question (e.g., “Did your speech go well?”) that they can correctly answer if they have correctly answered the word fragment. Participants then receive feedback about whether the comprehension question was answered correctly. For the proposed study, items have been adapted from those used by Cougle et al. (2019). There are 50 items in total, 25 of which are of a belonging affordance, and 25 of a burdensome affordance. Participants will be presented with a random selection of 10 belonging and 10 burdensome items in each of the four sessions.

All surveys and intervention sessions will be administered online via the Qualtrics platform. Half of the participants will be randomised to the treatment condition where they will complete the Sentence Completion task as described above, and half will be randomised to the control condition in which they will read the ambiguous first sentence of each item and answer the comprehension questions but will not be presented with the disambiguating second sentence or feedback following the comprehension question. This allows for the investigation of the efficacy of the treatment for negative interpretive bias, with perceived burdensomeness and thwarted belonging as primary outcomes and suicidal thinking as a secondary outcome.
Intervention code [1] 320052 0
Treatment: Other
Comparator / control treatment
This will be a placebo control trial. Half of the participants will be randomised to the treatment condition where they will complete the Sentence Completion task as described above, and half will be randomised to the control condition in which they will read the ambiguous first sentence of each item and answer the comprehension questions but will not be presented with the disambiguating second sentence or feedback following the comprehension question. In the control condition, participants do no receive any disambiguating information about the scenarios. Therefore, although they are participating in a similar task, they are not receiving the intervention portion of the task and their interpretation bias is not expected to change. This allows for the investigation of the efficacy of the treatment for negative interpretive bias, and in turn, the efficacy of treatment for perceived burdensomeness and thwarted belonging, and suicidal thinking.
Control group
Placebo

Outcomes
Primary outcome [1] 326903 0
Change in score for Interpretive Bias scenarios from pre- to post-intervention and difference in scores between treatment and control participants, as determined by an ambiguous scenarios test.
Timepoint [1] 326903 0
Following completion of four CBM-I intervention sessions.
Secondary outcome [1] 393050 0
Change in burdensomeness from pre- to post-intervention, and difference in scores between treatment and control participants as determined by Interpersonal Needs Questionnaire
Timepoint [1] 393050 0
Following completion of four CBM-I intervention sessions.
Secondary outcome [2] 393053 0
Change in suicidal ideation from pre- to post-intervention, and difference in scores between treatment and control participants, as determined by the Depressive Symptoms Inventory–Suicidality Subscale (indicating reduced suicidal ideation)
Timepoint [2] 393053 0
Following completion of four CBM-I intervention sessions.
Secondary outcome [3] 396045 0
Change in thwarted belonging as determined by Interpersonal Needs Questionnaire, from pre- tp post-intervention and difference in scores between treatment and control participants.
Timepoint [3] 396045 0
Following completion of four CBM-I intervention sessions.

Eligibility
Key inclusion criteria
Participants will be undergraduate psychology students from the University of Otago, recruited through the Department of Psychology research participation programme. Students select which studies they are interested in participating in. Those that select this study will be sent an invitation to complete the study via email.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is to be concealed by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Treatment efficacy will be examined by comparing pre- and post-treatment scores, and by comparing the active treatment and control groups.

Firstly, regression analyses will be used to predict post-treatment scores from pre-treatment scores, with treatment entered as a variable.

Secondly, treatment outcome effects will be tested using growth modelling within a latent variable framework. Intercept and growth slope factors will be obtained using growth modelling applied separately to each outcome variable. Treatment efficacy will be determined by testing whether treatment, coded as a dummy variable, predicts the growth slope factors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/07/2021
Actual
Date of last participant enrolment
Anticipated
16/08/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 23550 0
New Zealand
State/province [1] 23550 0
Otago

Funding & Sponsors
Funding source category [1] 308053 0
University
Name [1] 308053 0
University of Otago
Country [1] 308053 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
275 Leith Walk
Dunedin 9010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 308913 0
None
Name [1] 308913 0
Address [1] 308913 0
Country [1] 308913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308045 0
Northern B Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 308045 0
Ethics committee country [1] 308045 0
New Zealand
Date submitted for ethics approval [1] 308045 0
14/03/2021
Approval date [1] 308045 0
27/04/2021
Ethics approval number [1] 308045 0

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

Contacts
Principal investigator
Name 109330 0
Miss Rachel Knight
Address 109330 0
Psychology Department, University of Otago
275 Leith Walk
Dunedin 9010
New Zealand
Country 109330 0
New Zealand
Phone 109330 0
+64 272958835
Fax 109330 0
Email 109330 0
[email protected]
Contact person for public queries
Name 109331 0
Rachel Knight
Address 109331 0
Psychology Department, University of Otago
275 Leith Walk
Dunedin 9010
New Zealand
Country 109331 0
New Zealand
Phone 109331 0
+64 272958835
Fax 109331 0
Email 109331 0
[email protected]
Contact person for scientific queries
Name 109332 0
Rachel Knight
Address 109332 0
Psychology Department, University of Otago
275 Leith Walk
Dunedin 9010
New Zealand
Country 109332 0
New Zealand
Phone 109332 0
+64 272958835
Fax 109332 0
Email 109332 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?
Anonymised self-report data only.
When will data be available (start and end dates)?
Data will be available after study completion with no end date determined
Available to whom?
To researchers with legitimate interests, appropriate expertise, and the competence to manage the data appropriately.
Available for what types of analyses?
Unrestricted
How or where can data be obtained?
By e-mail to Assoc. Prof. Richard J. Linscott, Department of Psychology, P. O. Box 56, Dunedin, New Zealand. E-mail: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11455Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.