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Trial registered on ANZCTR


Registration number
ACTRN12624001419550
Ethics application status
Approved
Date submitted
6/11/2023
Date registered
4/12/2024
Date last updated
4/12/2024
Date data sharing statement initially provided
4/12/2024
Date results provided
4/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Behavioural Activation and Self-compassion to Cope with Academic Worry
Scientific title
A randomised controlled trial evaluating the use of Behavioural Activation and Self-compassion interventions to cope with academic worry in university students,
Secondary ID [1] 310901 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a parent study of the pilot study (ACTRN12621001614886).

Health condition
Health condition(s) or problem(s) studied:
academic worry 331956 0
general worry 331961 0
Condition category
Condition code
Mental Health 328684 328684 0 0
Anxiety
Mental Health 332316 332316 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Academic worry, conceptualised as a domain of general worry, refers to worries towards academic performance with respect to grades, assignments, class attendance, and examinations (Deffenbacher, 1980). Academic worry is the most salient factor that leads to poor academic achievement (Gibbs & Kenealey, 2022; Owens, Stevenson, & Hadwin, 2012; Putwain, Daly, Chamberlain, & Sadreddini, 2015), and is positively associated with negative psychological consequences such as anxiety, depression, and low self-esteem (Cassady & Johnson, 2002; Owens, Stevenson, & Hadwin, 2012; Yadusky-Holahan & Holahan, 1983). It is estimated that 25-40% of students experience worry and anxiety towards their academic performance and competence (Gregor, 2005; McDonald, 2001).

This trial contained two interventions, behavioural activation (BA) and self-compassion (SC), which aimed to manage academic worry in university students. The intervention programs consisted of two 45-minute in-person sessions in a laboratory with computer and pen-and-paper tasks and a three- and six-month follow-up, delivered weekly by a provisional psychologist with a bachelor's (honours) degree in psychology. Beyond these two in-person sessions of interventions, no other support or consultation was provided by the provisional psychologist.

Upon arrival at the first in-person session and after consenting, all participants were asked to complete questionnaires assessing academic worry, general worry, experiential avoidance, intolerance of uncertainty, self-compassion, and behavioural activation. Next, participants were asked to write about an academic-related issue that had been worrying them and reflected on their thoughts, feelings, and behaviours, Following this, they were randomly assigned to different conditions.

The BA program was based on Chen et al.'s (2013) behavioural activation program for excessive worry, which was adopted for academic worry in the current study. The program included psychoeducation, activity monitoring (identifying thoughts, feelings and behaviours related to academic avoidance), identifying goals and values related to the academic issues, activity scheduling, and homework that focused on activity scheduling, where participants selected up to two activities in an activity planner to help achieve a specific academic goal. Participants were required to record their practice in a worksheet to be reviewed at the second session.

The SC program was based on Neff's (2003) self-compassion, which comprised three interconnected components: self-kindness, common humanity, and mindfulness. The program began by introducing the key concepts of self-compassion and how to apply it in the context of academic worry, followed by a practice of self-kindness, common humanity, and mindfulness in responding to their academic issue through a guided audio recording with instructions. Homework was assigned for the participants to practice self-compassion between sessions and recorded their practice in a worksheet to be reviewed at the second session.

The second session was undertaken one week later, which began with participants’ brief reflection on what they had learned in the first session, followed by a review of their respective practice during the week in the SC and BA conditions to ensure their adherence to the respective program, At the end of the second session, all participants completed the post-intervention questionnaires including the same measures as those completed before the interventions. Participants were informed of the follow-up studies and are sent a link to the follow-up questionnaires three and six months after the completion of the second session.
Intervention code [1] 327327 0
Treatment: Other
Intervention code [2] 327328 0
Behaviour
Comparator / control treatment
The control condition adopted an online program from Christensen et al. (2014), which covered health-related topics. Participants were directed to the Eat for Health website (www.eatforhealth.gov.au) and were given a worksheet that contains instructions for them to explore the webpage with quizzes in order to stimulate their interest in the activity. Participants were also advised to act as they normally do between sessions.
Control group
Active

Outcomes
Primary outcome [1] 336500 0
academic worry
Timepoint [1] 336500 0
baseline, immediately post-intervention completion, 3- and 6-month (primary timepoint) follow-ups,
Secondary outcome [1] 428583 0
general worry
Timepoint [1] 428583 0
baseline, immediately post-intervention completion, 3- and 6-month follow-ups,
Secondary outcome [2] 428584 0
experiential avoidance
Timepoint [2] 428584 0
baseline, immediately post-intervention completion, 3- and 6-month follow-ups,
Secondary outcome [3] 428585 0
intolerance of uncertainty
Timepoint [3] 428585 0
baseline, immediately post-intervention completion, 3- and 6-month follow-ups,
Secondary outcome [4] 428586 0
self-compassion
Timepoint [4] 428586 0
baseline, immediately post-intervention completion, 3- and 6-month follow-ups,
Secondary outcome [5] 428587 0
behavioural activation
Timepoint [5] 428587 0
baseline, immediately post-intervention completion, 3- and 6-month follow-ups,

Eligibility
Key inclusion criteria
Participants were undergraduate students who reported moderate levels of academic worry based on Wolitzky-Taylor and Telch (2010), and who were English-speaking.

Moderate academic worry was defined as a score of 2 or higher on at least
one of the two questions from the AWQ, “distress about academic worry” and “life
disruption/ interference caused by worrying about school” on a scale of 0 (mild) to 4
(extreme).
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)
A researcher with no other involvement in the study generated a random block sequence for the allocation of participants to conditions using the IBM Statistical Package for the Social Sciences (IBM SPSS). The sequence contained sets of ones, twos and threes, corresponding to SC, BA and control respectively.
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We conducted a power analysis based on our pilot data (Chen et al., 2016) where the effect size for the changes in the SC and BA conditions from pre- to post-interventions compared to the control condition was f = 0.4. The calculation resulted in a total sample size of 122 (i.e., 41 participants per condition) that would provide 80% power at a .05 alpha level to detect condition differences across four assessment points on primary outcomes.

To test our hypotheses, a cross-lag panel analysis was performed to determine the effects of the interventions compared to the control condition. Specifically, we proposed a cross-lag panel model and examined (1) the differences between the two intervention (i.e., SC and BA) conditions and the control condition on academic worry, general worry, experiential avoidance, and intolerance of uncertainty at post-intervention, and at 3- and 6-month follow-ups; (2) the mediation effects of experiential avoidance and intolerance of uncertainty at post-intervention and (or) at 3-month follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/02/2017
Date of last participant enrolment
Anticipated
Actual
4/10/2018
Date of last data collection
Anticipated
Actual
15/04/2019
Sample size
Target
122
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315157 0
University
Name [1] 315157 0
Flinders University of South Australia
Country [1] 315157 0
Australia
Primary sponsor type
Individual
Name
Dr Junwen Chen, the School of Medicine and Psychology, Australian National University
Address
39 Science Road, Acton, ACT 2601
Country
Australia
Secondary sponsor category [1] 317177 0
None
Name [1] 317177 0
Address [1] 317177 0
Country [1] 317177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314094 0
Social and Behavioural Ethics Committee
Ethics committee address [1] 314094 0
Ethics committee country [1] 314094 0
Australia
Date submitted for ethics approval [1] 314094 0
03/04/2015
Approval date [1] 314094 0
01/06/2015
Ethics approval number [1] 314094 0

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

Contacts
Principal investigator
Name 130386 0
Dr Junwen Chen
Address 130386 0
39 Science Road, Acton, ACT 2601, School of Medicine and Psychology, Australian National University
Country 130386 0
Australia
Phone 130386 0
+61 2 6125 2038
Fax 130386 0
Email 130386 0
junwen.chen@anu.edu.au
Contact person for public queries
Name 130387 0
Junwen Chen
Address 130387 0
39 Science Road, Acton, ACT 2601, School of Medicine and Psychology, Australian National University
Country 130387 0
Australia
Phone 130387 0
+61 2 6125 2038
Fax 130387 0
Email 130387 0
junwen.chen@anu.edu.au
Contact person for scientific queries
Name 130388 0
Junwen Chen
Address 130388 0
39 Science Road, Acton, ACT 2601, School of Medicine and Psychology, Australian National University
Country 130388 0
Australia
Phone 130388 0
+61 2 6125 2038
Fax 130388 0
Email 130388 0
junwen.chen@anu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect participant confidentiality and align with ethics requirements


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20828OtherChen, J., Cárdenas, D., Zhang, B., & Huang, L. (2023). Using Behavioural Activation and Self-compassion to Cope with Academic Worry. Open paper at the 51st Annual Conference & Workshops of the British Dissociation for Behavioural & Cognitive Psychotherapy. July 11-13th, Cardiff, the UK.  junwen.chen@anu.edu.au presentation slides available via email request
24362OtherChen, J., & Huang, L. (2018). Coping with academic worry: the role of experiential avoidance and intolerance of uncertainty as underlying mechanisms of symptom change. Poster presented at the 52nd Annual Convention of the Association for Behavioral and Cognitive Therapies in November, Washington DC, USA.  junwen.chen@anu.edu.au poster presented at the conferences available via ... [More Details]
24363OtherChen, C., Tee, A., & Johnstone, K. (2016). Targeting Experiential Avoidance in academic worry: using Behavioural activation and self-compassion strategies. Symposium presentation at the 8th World Congress of Behavioural and Cognitive Therapies, June, Melbourne, Australia. junwen.chen@anu.edu.au presentation slides available via email request



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.