Trial Review

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
ACTRN12611000240943
Ethics application status
Approved
Date submitted
1/03/2011
Date registered
4/03/2011
Date last updated
12/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptance and Commitment Therapy (ACT) for rumination and worry in individuals with anxiety and depression: A randomized control trial
Scientific title
Treating worry and rumination in individuals with anxiety and depression using Acceptance and Commitment Therapy, measuring symptom reduction, acceptance-based attitudes, level of disability and engagement in valued living
Secondary ID [1] 259710 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 261286 0
Dysthymic disorder 261287 0
Anxiety disorders excluding Obsessive Compulsive Disorder and Post-Traumatic Stress Disorder 261288 0
Condition category
Condition code
Mental Health 259434 259434 0 0
Depression
Mental Health 259435 259435 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACT is a mindfulness, acceptance and values-based psychotherapy which proposes different processes of change and outcome compared to traditional cognitive and behavioural treatments (Hayes, Masuda, & De Mey, 2003). In ACT, acceptance, mindfulness and values strategies are used to create a context for an individual to engage in effective and valued behaviours, even in the presence of difficult thoughts and emotions.
The intervention for this study is ACT delivered in group format, based on therapy protocols by Glaser, Blackledge, and Deane (2008) and Zettle (2007). It will consist of 8 X 2-hour group sessions, delivered weekly. The therapy will be delivered by provisional psychologists.
Intervention code [1] 264138 0
Treatment: Other
Intervention code [2] 264163 0
Behaviour
Comparator / control treatment
The control treatment is Cognitive Behavioural Therapy (CBT), which is the current psychological treatment of choice for anxiety and depression. CBT will be delivered in group format according to therapy protocol by Nathan et al. (2004). The control treatment will consist of 8 X 2-hour group sessions, delivered weekly. The therapy will be delivered by provisional psychologists.
Control group
Active

Outcomes
Primary outcome [1] 262241 0
Depression, Anxiety and Stress Scales (DASS-21)
Timepoint [1] 262241 0
1. Baseline
2. Weekly during the intervention
3. Post-treatment
4. At 3 months follow-up
5. At 6 months follow-up
Primary outcome [2] 262242 0
Penn State Worry Questionnaire (PSWQ)
Timepoint [2] 262242 0
1. Baseline
2. Weekly during the intervention
3. Post-treatment
4. At 3 months follow-up
5. At 6 months follow-up
Primary outcome [3] 262243 0
Ruminative Thought Style Questionnaire (RTS)
Timepoint [3] 262243 0
1. Baseline
2. Weekly during the intervention
3. Post-treatment
4. At 3 months follow-up
5. At 6 months follow-up
Secondary outcome [1] 273372 0
Acceptance and Action Questionnaire-II (AAQ-II)
Timepoint [1] 273372 0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Secondary outcome [2] 273373 0
White Bear Suppression Inventory (WBSI)
Timepoint [2] 273373 0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Secondary outcome [3] 273374 0
Valued Living Questionnaire (VLQ)
Timepoint [3] 273374 0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Secondary outcome [4] 273375 0
Behavioural Activation for Depression Scale (BADS)
Timepoint [4] 273375 0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Secondary outcome [5] 273376 0
Sheehan Disability Scale
Timepoint [5] 273376 0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Secondary outcome [6] 273377 0
Mindful Attention and Awareness Scale (MAAS)
Timepoint [6] 273377 0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Secondary outcome [7] 273379 0
Automatic Thoughts Questionnaire (ATQ)
Timepoint [7] 273379 0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up

Eligibility
Key inclusion criteria
A diagnosis of major depressive disorder, dysthymic disorder or an anxiety disorder where worry and rumination are prominent features. Each participant’s eligibility will be assessed using the depression and anxiety modules of the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (Patient Edition, with Psychotic Screen; First, Gibbon, Spitzer, & Williams, 2007).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who meet the inclusion criteria but who have co-morbid psychosis, suicidal intent, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder or an eating disorder will be excluded from participating in the study.

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)
Participants will be recruited from thew community.

Allocation to the groups will be undertaken by senior research staff member not involved with the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple radomisation 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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264591 0
University
Name [1] 264591 0
RMIT University
Country [1] 264591 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Road,
Bundoora,
Vic 3083
Country
Australia
Secondary sponsor category [1] 263731 0
None
Name [1] 263731 0
Address [1] 263731 0
Country [1] 263731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260585 0
RMIT Human Research Ethics Comittee
Ethics committee address [1] 260585 0
GPO Box 2476
Melbourne
VIC 3001
Australia
Ethics committee country [1] 260585 0
Australia
Date submitted for ethics approval [1] 260585 0
15/11/2010
Approval date [1] 260585 0
12/04/2011
Ethics approval number [1] 260585 0
62/10

Summary
Brief summary
Acceptance and Commitment Therapy (ACT; Hayes, Strosahl & Wilson, 1999) is a third-wave behavioural therapy that has been receiving greater attention in the empirical literature in recent years. ACT is a mindfulness, acceptance and values-based psychotherapy which proposes different processes of change and outcome compared to traditional cognitive and behavioural treatments (Hayes, Masuda, & De Mey, 2003). In ACT, acceptance, mindfulness and values strategies are used to create a context for an individual to engage in effective and valued behaviours, even in the presence of difficult thoughts and emotions. Within an ACT framework, two key processes are seen as contributing to the development and maintenance of many forms of psychopathology: experiential avoidance (i.e. behavioural and psychological attempts to avoid an unpleasant experience) and cognitive fusion (i.e. responding to a thought or feeling as if it were the actual event it describes; Hayes, Strosahl, & Wilson, 1999; Hayes, Wilson, Gifford, Follette, & Strosahl, 1996).

Chronic worry and rumination are key cognitive processes associated with the onset and maintenance of generalised anxiety disorder (GAD) and depression (Hoeksema, Wisco, & Lyubomirsky, 2008; Watkins, 2008). Worry and rumination have been considered by researchers to be forms of both experiential avoidance and cognitive fusion. The literature on clinical interventions for rumination is surprisingly scarce, and although there are currently a number of efficacious cognitive behavioural treatments for chronic worry and GAD, it is evident that there is room for improvement as only about half of those treated are achieving high end state functioning (Hayes, Orsillo & Roemer, 2010).

To date, beyond case studies (Ruiz, 2010) there has been no research specifically investigating ACT for chronic worry and rumination amongst sufferers of GAD and Depression. A randomised control trial comparing ACT to CBT will address this gap in the literature and inform the treatment and management of anxiety and depression. Furthermore, investigating the mechanisms of change, specifically that of acceptance of psychological experience and greater behavioural engagement with valued areas of life, will enhance our understanding of the predictive elements of ACT and improve its application in the treatment of mood and anxiety disorders.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32294 0
Address 32294 0
Country 32294 0
Phone 32294 0
Fax 32294 0
Email 32294 0
Contact person for public queries
Name 15541 0
Monique Slevison
Address 15541 0
RMIT University
School of Health Sciences
P.O Box 71, Bundoora
Vic 3083
Country 15541 0
Australia
Phone 15541 0
+61 (0)416 510 068
Fax 15541 0
Email 15541 0
[email protected]
Contact person for scientific queries
Name 6469 0
Dr. Keong Yap
Address 6469 0
RMIT University
School of Health Sciences
P.O Box 71, Bundoora
Vic 3083
Country 6469 0
Australia
Phone 6469 0
+61 3 9925 6692
Fax 6469 0
Email 6469 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.