Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
259710
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder
261286
0
Query!
Dysthymic disorder
261287
0
Query!
Anxiety disorders excluding Obsessive Compulsive Disorder and Post-Traumatic Stress Disorder
261288
0
Query!
Condition category
Condition code
Mental Health
259434
259434
0
0
Query!
Depression
Query!
Mental Health
259435
259435
0
0
Query!
Anxiety
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
264138
0
Treatment: Other
Query!
Intervention code [2]
264163
0
Behaviour
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
262241
0
Depression, Anxiety and Stress Scales (DASS-21)
Query!
Assessment method [1]
262241
0
Query!
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
Query!
Primary outcome [2]
262242
0
Penn State Worry Questionnaire (PSWQ)
Query!
Assessment method [2]
262242
0
Query!
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
Query!
Primary outcome [3]
262243
0
Ruminative Thought Style Questionnaire (RTS)
Query!
Assessment method [3]
262243
0
Query!
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
Query!
Secondary outcome [1]
273372
0
Acceptance and Action Questionnaire-II (AAQ-II)
Query!
Assessment method [1]
273372
0
Query!
Timepoint [1]
273372
0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Query!
Secondary outcome [2]
273373
0
White Bear Suppression Inventory (WBSI)
Query!
Assessment method [2]
273373
0
Query!
Timepoint [2]
273373
0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Query!
Secondary outcome [3]
273374
0
Valued Living Questionnaire (VLQ)
Query!
Assessment method [3]
273374
0
Query!
Timepoint [3]
273374
0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Query!
Secondary outcome [4]
273375
0
Behavioural Activation for Depression Scale (BADS)
Query!
Assessment method [4]
273375
0
Query!
Timepoint [4]
273375
0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Query!
Secondary outcome [5]
273376
0
Sheehan Disability Scale
Query!
Assessment method [5]
273376
0
Query!
Timepoint [5]
273376
0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Query!
Secondary outcome [6]
273377
0
Mindful Attention and Awareness Scale (MAAS)
Query!
Assessment method [6]
273377
0
Query!
Timepoint [6]
273377
0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Query!
Secondary outcome [7]
273379
0
Automatic Thoughts Questionnaire (ATQ)
Query!
Assessment method [7]
273379
0
Query!
Timepoint [7]
273379
0
1. Baseline
2. Post-treatment
3. At 3 months follow-up
4. At 6 months follow-up
Query!
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).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple radomisation using a randomisation table created by computer software
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/04/2011
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
50
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
264591
0
University
Query!
Name [1]
264591
0
RMIT University
Query!
Address [1]
264591
0
Plenty Road,
Bundoora,
Vic 3083
Query!
Country [1]
264591
0
Australia
Query!
Primary sponsor type
University
Query!
Name
RMIT University
Query!
Address
Plenty Road,
Bundoora,
Vic 3083
Query!
Country
Australia
Query!
Secondary sponsor category [1]
263731
0
None
Query!
Name [1]
263731
0
Query!
Address [1]
263731
0
Query!
Country [1]
263731
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260585
0
RMIT Human Research Ethics Comittee
Query!
Ethics committee address [1]
260585
0
GPO Box 2476 Melbourne VIC 3001 Australia
Query!
Ethics committee country [1]
260585
0
Australia
Query!
Date submitted for ethics approval [1]
260585
0
15/11/2010
Query!
Approval date [1]
260585
0
12/04/2011
Query!
Ethics approval number [1]
260585
0
62/10
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32294
0
Query!
Address
32294
0
Query!
Country
32294
0
Query!
Phone
32294
0
Query!
Fax
32294
0
Query!
Email
32294
0
Query!
Contact person for public queries
Name
15541
0
Monique Slevison
Query!
Address
15541
0
RMIT University
School of Health Sciences
P.O Box 71, Bundoora
Vic 3083
Query!
Country
15541
0
Australia
Query!
Phone
15541
0
+61 (0)416 510 068
Query!
Fax
15541
0
Query!
Email
15541
0
[email protected]
Query!
Contact person for scientific queries
Name
6469
0
Dr. Keong Yap
Query!
Address
6469
0
RMIT University
School of Health Sciences
P.O Box 71, Bundoora
Vic 3083
Query!
Country
6469
0
Australia
Query!
Phone
6469
0
+61 3 9925 6692
Query!
Fax
6469
0
Query!
Email
6469
0
[email protected]
Query!
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.
Download to PDF