Trial Review

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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] 284250 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
excessive worry 291365 0
Condition category
Condition code
Mental Health 291730 291730 0 0
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] 289004 0
Behaviour
Intervention code [2] 289005 0
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] 291668 0
excessive worry: The Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990) will be used to measure pathological worry .
Timepoint [1] 291668 0
baseline (screening survey), pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [1] 307259 0
Depression Anxiety Stress Scales
Timepoint [1] 307259 0
baseline, pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [2] 307348 0
The Work and Social Adjustment Scale
Timepoint [2] 307348 0
Baseline, pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [3] 307349 0
The Cognitive-Behavioural Avoidance Scale
Timepoint [3] 307349 0
Baseline, pre-treatment, post-treatment, 3-month follow-up
Secondary outcome [4] 307350 0
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] 307350 0
Before each treatment session (8 timepoint) and each weekend during the 3-month follow-up
Secondary outcome [5] 307351 0
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] 307351 0
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?
No
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
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288875 0
University
Name [1] 288875 0
Faculty Research Grant, Faculty of Social and Behavioural Sciences, Flinders University
Country [1] 288875 0
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] 287569 0
None
Name [1] 287569 0
Address [1] 287569 0
Country [1] 287569 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290704 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 290704 0
The Flats G5 – Rooms 3 and 4
Flinders Drive
c/- Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 290704 0
Australia
Date submitted for ethics approval [1] 290704 0
14/03/2014
Approval date [1] 290704 0
Ethics approval number [1] 290704 0

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 46886 0
Dr Junwen Chen
Address 46886 0
School of Psychology, Flinders University, GPO Box 2100 Adelaide, SA 5001, AUSTRALIA
Country 46886 0
Australia
Phone 46886 0
+61 882012601
Fax 46886 0
Email 46886 0
[email protected]
Contact person for public queries
Name 46887 0
Dr Junwen Chen
Address 46887 0
School of Psychology, Flinders University, GPO Box 2100 Adelaide, SA 5001, AUSTRALIA
Country 46887 0
Australia
Phone 46887 0
+61 882012601
Fax 46887 0
Email 46887 0
[email protected]
Contact person for scientific queries
Name 46888 0
Dr Junwen Chen
Address 46888 0
School of Psychology, Flinders University, GPO Box 2100 Adelaide, SA 5001, AUSTRALIA
Country 46888 0
Australia
Phone 46888 0
+61 882012601
Fax 46888 0
Email 46888 0
[email protected]

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