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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anxiety

depression

worry

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

Penn State Worry Questionnaire for-Children

Timepoint [1]

pre-treatment, post-treatment, 3-month follow-up

Secondary outcome [1]

Depression Anxiety Stress Scales-21

Timepoint [1]

pre-treatment, post-treatment; 3-month follow-up

Secondary outcome [2]

Behavioral Activation of Depression Scale

Timepoint [2]

pre-treatment, post-treatment, 3-month follow-up

Secondary outcome [3]

The Intolerance of Uncertainty Scale for Children

Timepoint [3]

pre-treatment, post-treatment, 3-month follow-up

Secondary outcome [4]

Health-related quality of life – Short Form 12

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

2015 Faculty Research Grant, Faculty of Social and Behavioural Sciences, Flinders University

Address [1]

GPO Box 2100 Adelaide, SA 5001

Country [1]

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]

Individual

Name [1]

Miss Justine Xue

Address [1]

School of Psychology, Flinders University, GPO Box 2100 Adelaide, SA 5001

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre 
Flinders Drive 
Bedford Park 5042 
South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/04/2015

Approval date [1]

Ethics approval number [1]

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

Dr Junwen Chen

Address

School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001

Country

Australia

Phone

+61 8 8201 2601

Fax

junwen.chen@flinders.edu.au

Contact person for public queries

Name

Junwen Chen

Address

School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001

Country

Australia

Phone

+61 8 8201 2601

Fax

junwen.chen@flinders.edu.au

Contact person for scientific queries

Name

Junwen Chen

Address

School of Psychology
Flinders University
GPO Box 2100 Adelaide, SA 5001

Country

Australia

Phone

+61 8 8201 2601

Fax

junwen.chen@flinders.edu.au

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

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