Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12615000433505
Ethics application status
Not yet submitted
Date submitted
19/04/2015
Date registered
6/05/2015
Date last updated
6/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a transdiagnostic treatment for excessive worry in youth: A randomised trial of brief Behavioural Activation
Scientific title
Efficacy of a transdiagnostic treatment for excessive worry in youth: A randomised trial of brief Behavioural Activation
Secondary ID [1] 286558 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 294803 0
depression 294804 0
worry 294805 0
Condition category
Condition code
Mental Health 295080 295080 0 0
Depression
Mental Health 295081 295081 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural Activation

The core goals of Behavioural Activation for worry (BAW) are to help participants identify avoidant patterns and activate competing behaviours. The treatment includes 8 weekly group sessions, with each session including 6 participants and lasting for 90 minutes.

Session 1: Psycho-education on functional impact of excessive and uncontrollable worry and the Behavioural Activation treatment model. Introducing self-monitoring through a Daily Activity Record as homework for the following week.

Session 2: Undertaking functional assessment of the Daily Activity Record to create awareness of avoidant patterns related to worry and its consequences. Identifying participants’ short term and life goals which, together with the functional assessments of their avoidance patterns to help them develop alternative goal oriented behaviours.

Sessions 3-7: Encouraging participants to activate competing behaviours in accordance with their goals, to observe the results of their coping strategies, and to evaluate their own progress. Teaching self-administered rewards are on a weekly basis for participants’ incremental behavioural change. During this process, emphasising that the aim is to start working on important tasks, increase activation and disrupt avoidance. Activity scheduling is incorporated in the form of weekly homework activities.

From Session 6-8: Emphasising the importance of repetition and integrating change into daily routine. Encouraging participants to link the short-term goals set in Session 2 with long-term life goals and develop a hierarchy of steps based on selected activities towards achieving long-term goals.

Session 8: Reviewing the previous sessions and discussing relapse prevention strategies.

All the treatment sessions will be conducted by a Provisional Psychologist as the principal therapist, and a Clinical masters student as the co-therapist. The co-therapist will monitor the attendance at each group session.


Intervention code [1] 291663 0
Treatment: Other
Intervention code [2] 291664 0
Behaviour
Comparator / control treatment
waitlist control, participants in this condition will be offered the Behavioural Activation treatment after the completion of their waitlist (i.e., 8 weeks).
Control group
Active

Outcomes
Primary outcome [1] 294844 0
Penn State Worry Questionnaire for-Children
Timepoint [1] 294844 0
pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [1] 314187 0
Depression Anxiety Stress Scales-21
Timepoint [1] 314187 0
pre-treatment, post-treatment; 3-month follow-up
Secondary outcome [2] 314188 0
Behavioral Activation of Depression Scale
Timepoint [2] 314188 0
pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [3] 314189 0
The Intolerance of Uncertainty Scale for Children
Timepoint [3] 314189 0
pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [4] 314190 0
Health-related quality of life – Short Form 12
Timepoint [4] 314190 0
pre-treatment, post-treatment, 3-month follow-up

Eligibility
Key inclusion criteria
Our inclusion criteria are age (14-18 years); greater than or equal to 20.8 raw scores on the PSWQ-C (Chorpita et al., 1997), 28 raw depression scores and 20 anxiety scores on the DASS-21 (Lovibond & Lovibond, 1995) as well as a goal to address worry.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they report current treatment for worry related issues, active suicidal ideation, psychosis, or alcohol and drug dependency, according to the M.I.N.I. diagnostic interview. Antidepressant medication is not an exclusion criterion if participants agree to stay on constant dosage for at least two months prior to involvement and willing to keep medication status stable until the end of the follow-up (3 months).

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 was concealed by a statistician who is off-site using a number generator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be 1:1 using a random number generator that will allow for similar numbers in each treatment condition
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 291121 0
University
Name [1] 291121 0
2015 Faculty Research Grant, Faculty of Social and Behavioural Sciences, Flinders University
Country [1] 291121 0
Australia
Primary sponsor type
Individual
Name
Dr Junwen Chen
Address
School of Psychology, Flinders University, GPO Box 2100 Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 289796 0
Individual
Name [1] 289796 0
Miss Justine Xue
Address [1] 289796 0
School of Psychology, Flinders University, GPO Box 2100 Adelaide, SA 5001
Country [1] 289796 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292701 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 292701 0
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Ethics committee country [1] 292701 0
Australia
Date submitted for ethics approval [1] 292701 0
24/04/2015
Approval date [1] 292701 0
Ethics approval number [1] 292701 0

Summary
Brief summary
Around 25% of adolescents report excessive and uncontrollable worry and many adult high worriers report that their excessive worry began in late adolescence (Kerts &Woodruff-Borden, 2011). Younger adults (16-29 years of age) report a higher frequency of worry than older adults about school or work, finances and social interactions (Goncalves & Byrne, 2012). Worry functions as a cognitive avoidance response, suppressing images and somatic activation and preventing the individual from emotional processing of fear that is important for successful habituation and extinction (Stapinski, Abbott, & Rapee, 2010). Such avoidance brings initial relief but results in anxiety maintenance. Worry is an essential feature of Generalised Anxiety Disorder (GAD) and is a presenting characteristic across all anxiety disorders and depressive disorders (Starcevic, et al., 2007). Thus, worry presents an ideal target for transdiagnostic treatment that targets the common features across anxiety and depression.

To target worry as a transdiagnostic process, Chen et al. (2013) developed and evaluated a transdiagnostic approach targeting avoidance strategies in adult worriers by using Behavioural Activation treatment. Behavioural Activation (BA) was originally developed to address avoidance in depression (Addis & Martell, 2004) and its efficacy has been shown in a number of randomised controlled trials. When applied to worry, BA is expected to break down patterns of anxious avoidance through repeated exposure to goal orientated behaviours. Viewing worry as a form of avoidance, BA encourages clients to identify avoidance patterns and increase alternate behaviours in the face of worry-provoking situations (Chen, et al., 2013). Compared to more complex treatment packages, two key advantages of BA are: 1) it is simpler to deliver (Hopko, et al., 2003); and 2) it is efficacious, even when delivered by mental health professionals with minimal training (Ekers, et al., 2011). This simplicity is especially appealing for treating young people as some researchers have criticised that the “extreme comprehensiveness” of the CBT protocol is a primary problem for youth and recommended a low-intensity intervention (Hollon, Garber, & Shelton, 2005).

The effect of BAW on anxiety and depression has been demonstrated in our pilot trial (Chen et al., 2013) within a community sample of adults. Findings revealed that participants who received an 8-week group based BAW showed significantly greater reduction in worry, depression and characteristics such as cognitive avoidance, intolerance of uncertainty and problem-solving orientation than the waitlist. Twice as many individuals showed clinically significant reductions in excessive worry after BAW compared to the waitlist. These results provide promising support for BAW as a practical transdiagnostic treatment for worry. Hence the current project aims to investigate the efficacy of BAW in young people.

Recent developments in cognitive models of worry and treatments for youth are mostly based on adult research (Vasey, 1993) and studies have demonstrated the applicability of the cognitive model or processes in adults to youth (Laugesen, Dugas, & Bukowski, 2003). However, differences in cognitive, social, and emotional development between adolescents and adults must be taken into account (Vasey, 1993). The present project will examine whether BAW is superior to a waitlist control condition in improving worry in anxious and depressed youths after an 8-week treatment/waitlist and a 3-month follow-up. We will also compare the effect of BAW vs. waitlist on a series of secondary outcomes (i.e., distress, behavioural activation, intolerance of uncertainty, life impairment).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56630 0
Dr Junwen Chen
Address 56630 0
School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001
Country 56630 0
Australia
Phone 56630 0
+61 8 8201 2601
Fax 56630 0
Email 56630 0
[email protected]
Contact person for public queries
Name 56631 0
Junwen Chen
Address 56631 0
School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001
Country 56631 0
Australia
Phone 56631 0
+61 8 8201 2601
Fax 56631 0
Email 56631 0
[email protected]
Contact person for scientific queries
Name 56632 0
Junwen Chen
Address 56632 0
School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001
Country 56632 0
Australia
Phone 56632 0
+61 8 8201 2601
Fax 56632 0
Email 56632 0
[email protected]

No information has been provided regarding IPD availability


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.