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Trial registered on ANZCTR

Registration number

ACTRN12614000313639

Ethics application status

Not yet submitted

Date submitted

12/03/2014

Date registered

25/03/2014

Date last updated

25/03/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomized controlled trial of mindfulness and acceptance-based group therapy for excessive worry

Scientific title

A randomized controlled trial comparing a mindfulness and acceptance-based group therapy with a waitlist control for excessive worry in community populations

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

excessive worry

Condition category

Condition code

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Mindfulness and acceptance-based group therapy (MABGT) for excessive worry includes 8 group sessions (1 x 2 hours session per week for 8 weeks) with 6 participants in each group. The MABGT program is based on the treatment manual for Geralized Anxiety Disorder (GAD) by Roemer & Orsillo (2005, 2007). The current study will only include the acceptance component in the original program and modify it to an eight-session intervention based on the procedure in the previous studies (Craigie, et al., 2008; Evans, et al., 2008). The MABGT begins with psychoeducation about worry and its function as experiential avoidance and how this impacts on performance and quality of life. Mindfulness practice is included to promote awareness and acceptance along with breathing exercise, progressive muscle relaxation and exploration of personal values. Self-monitoring forms are used to monitor daily activities to understand how often they engage in a specific valued activity and their internal experience (thoughts, feelings and bodily sensations).

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Waitlist: Participants will be told to wait for 8 weeks before receiving an intervention. They will receive the MABGT after 8 weeks of waitlist.

Control group

Active

Outcomes

Primary outcome [1]

excessive worry: The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) will be used to measure pathological worry .

Timepoint [1]

baseline (screening survey), pre-treatment, post-treatment, 3-month follow-up

Secondary outcome [1]

Depression Anxiety Stress Scales

Timepoint [1]

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

Secondary outcome [2]

The Work and Social Adjustment Scale

Timepoint [2]

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

Secondary outcome [3]

The Cognitive-Behavioural Avoidance Scale

Timepoint [3]

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

Secondary outcome [4]

Weekly Assessment of activities: This 3-item questionnaire assesses the percentage of time participants spend in certain intervention-relevant activities over the preceding week on a 0-100 scale (e.g., worrying, activities or acceptance exercises).

Timepoint [4]

Before each treatment session (8 timepoint) and each weekend during the 3-month follow-up

Secondary outcome [5]

cognitive functioning: A go/no-go task will be used to assess executive functioning. Participants have to react to frequent go stimuli as fast as possible and have to inhibit responses to infrequent no-go stimuli. Reaction times to go/no-go tasks will be measured to test threat engagement and disengagement bias towards worry-related threat stimuli compared to neutral stimuli.

Timepoint [5]

pre-treatment, post-treatment

Eligibility

Key inclusion criteria

age (18-60 years old), self-reported excessive and uncontrollable worry, a stated treatment goal to address worry, and raw scores of 55 or higher on the Penn State Worry Questionnaire

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

current treatment for worry related issues, active suicidal ideation, psychosis, or alcohol and drug dependency.

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)

When volunteers make an enquiry through email or phone, a research assistant (Ms Kirstie Salter) will conduct a 15-minute telephone interview to assess the individual’s apparent eligibility and answer any queries. Following telephone screening, participants will be directed to a website link to complete the screening questionnaires assessing for excessive worry, life interference, active psychosis, suicidal ideation and alcohol/substance use. Prior to completing the online questionnaire, potential participants will receive an on-screen letter of introduction and an information sheet explaining what is required by participation. Consent is then obtained by the participant pressing an “I agree” button after reading them. Individuals who meet the inclusion criteria will be invited to participate in the study. Participants who consent will be randomly allocated to either MABGT or waitlist. Allocation is not concealed. Randomisation will be done using a random number generator in blocks that will allow for similar numbers in each treatment condition. All participants will complete the assessment measures at baseline and after treatment/waitlist. Participants in active treatment will also be sent email links to online follow-up questionnaires at 3 months after the treatment completion. All waitlist participants will be offered the MABGT at week 8 after their waitlist period.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

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

In Craigie, et al. (2008), post-treatment response of participants with GAD in a mindfulness-based cognitive therapy compared to their pre-treatment in PSWQ was 9.26 with a baseline standard deviation of 6.57. When this effect size is considered with an overall alpha level of .05 and a power of 80%, 22 participants per group are needed. Allowing for 20% attrition rate 30 per group are needed.

Separate outcome analyses will be conducted with the completer sample and the primary intent-to-treat sample. Missing data for dropouts will be estimated using multiple imputation strategies (Rubin, 1996). Our primary analysis comprises a pairwise comparison between MABGT vs. waitlist. The clinical significance of pre-post differences will be assessed using Cohen’s d statistic. The percentage of participants achieving statistically reliable change on the Penn State Worry Questionnaire (PSWQ) will be determined using the reliable change index (Jacobson & Traux, 1991).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

2/06/2014

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]

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

University

Name

Faculty of Social and Behavioural Sciences, Flinders University

Address

GPO Box 2100, Adelaide, SA, 5001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)

Ethics committee address [1]

The Flats G5 – Rooms 3 and 4
Flinders Drive
c/- Flinders Medical Centre, Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/03/2014

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Anxiety and depression co-occur highly with each other, with 69% of anxious youth being diagnosed with depression and up to 75% of depressed youth meeting criteria for an anxiety disorder (Angold, Costello, & Erkanli, 1999). When different classes of disorders co-occur at such high rates, selecting an appropriate treatment approach can be challenging. 

Traditional CBT for anxiety or depression are mostly single-target approaches focusing specifically on either anxiety or depression. Evidence-based interventions for multiple problems required a therapist to prioritise treatment goals and treat one problem at a time (Barlow, Allen, & Choate, 2004). However, this approach risks client drop out before he or she receives essential treatment for co-occurring difficulties (Rohde, 2012). In addition, multiple interventions are often costly to the public health care system (Jacobson, Martell, & Dimidjian, 2001). Given that the high comorbidity rates complicate the conceptualisation and provision of treatment and are generally associated with higher dropout, lower recovery, and poorer maintenance of gains (Rohde, 2012), treatment strategies that are flexible enough to accommodate diverse problems are needed. Recent development in unified treatments suggests that a transdiag-nostic approach appears to be more efficient and effective than treating disorders in a serial manner (Barlow et al., 2004). 

Unlike most traditional disorder specific treatments, transdiagnostic approaches target common features underlying symptoms in comorbid disorders (Barlow et al., 2004). They are more time-efficient and cost effective, simplifying treatment for both the client and therapist, which could improve the quality of care and satisfy a great need in public health (Rohde, 2012). Recent research (Barlow, et al., 2004) has identified that one of the common features in anxiety and depression is worry, a repetitive negative valanced process that reflects an unsuccessful attempt to prevent the occurrence of negative events or to devise coping strategies in case such events occur. 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).

Worry is characterised by the repeated experience of thoughts about potential negative events, and reported proneness to worry varies continuously across the normal population (Ruscio, Borkovec, & Ruscio, 2001). According to the most widely recognized model of GAD (Borkovec, Alcaine, & Behar, 2004), 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 (Foa, Huppert, & Cahill, 2006). Such avoidance brings initial relief but results in anxiety maintenance. The repetitive negative thoughts involving anticipating future threat in worriers may disrupt the implementation of effective strategies to solve problems, resulting in maintained or exacerbated levels of distress. Resent data has also highlighted the importance of behavioural avoidance in worry such as reassurance seeking, procrastinating, or over-preparing, aimed at reducing distress in the short term but contributing to the long term maintenance of symptoms (Beesdo-Baum et al., 2012). Therefore, an approach targeting such avoidance strategies in worriers is warranted.

Drawing from findings by Borkovec and colleagues (2004), Roemer and Orsillo (2005, 2007) argued that cognitive avoidance in worry may be experiential. That is, excessive worriers may be actively and/or automatically avoiding unpleasant internal experiences (thoughts, feelings, or bodily sensations) by focusing on future events and such avoidance is paradoxically associated with increased distress. Accordingly, training in the skill of mindfulness (i.e., paying attention, on purpose, in the present moment in a non-evaluative and expanded way to both internal and external sensations) may help to break this habitual anxious cycle of worry. An acceptance-based behaviour therapy (ABBT) was developed to specifically target the experiential avoidance in people with generalized anxiety disorder (Roemer & Orsillo, 2005; Roemer & Orsillo, 2007). The principles of the ABBT include (1) expanding present-moment awareness, (2) encouraging acceptance (a willingness to have one’s internal responses in order to participate in meaningful experiences) rather than judgment and avoidance of internal experiences, and (3) promoting action in areas of importance to the individual. A recent meta-analysis has revealed that ABBT is effective at reducing worry and that gains are largely maintained at follow-up (Hanrahan, Field, Jones, & Davey, 2013). Further, Hayes, Orsillo, & Roemer (2010) found that both acceptance of internal experiences and engagement in meaningful activities were related to treatment responder’s status at post-treatment and predicted treatment outcome. Specifically, change in acceptance was related to quality of life at post-treatment. Based on these findings, the current study will emphasise the acceptance component and investigate whether such acceptance approach is effective at improving excessive worry in a sample of community populations. Specifically, we investigate the effect of a mindfulness and acceptance-based group therapy (MABGT) for excessive worry by comparing it with a waitlist control.

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, AUSTRALIA

Country

Australia

Phone

+61 882012601

Fax

[email protected]

Contact person for public queries

Name

Junwen Chen

Address

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

Country

Australia

Phone

+61 882012601

Fax

[email protected]

Contact person for scientific queries

Name

Junwen Chen

Address

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

Country

Australia

Phone

+61 882012601

Fax

[email protected]

No information has been provided regarding IPD availability

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No Supporting Document Provided

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