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Trial registered on ANZCTR


Registration number
ACTRN12609000807257
Ethics application status
Not yet submitted
Date submitted
11/09/2009
Date registered
16/09/2009
Date last updated
16/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A preliminary investigation of the efficacy of an enhanced Cognitive Behavioural Treatment Program for Excessive Worry.
Scientific title
A preliminary investigation of the efficacy of an enhanced Cognitive Behavioural Treatment Program for Excessive Worry in individuals with Generalized Anxiety Disorder (GAD) using a case studies design.
Secondary ID [1] 1095 0
Nil
Universal Trial Number (UTN)
U1111-1111-8049
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive worries in individuals with Generalized Anxiety Disorder (GAD) 243815 0
Condition category
Condition code
Mental Health 239987 239987 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioural Therapy
a) the duration & frequency of therapy sessions: 12 x 1-hour sessions on a weekly basis.
b) the overall duration of the therapy program: 12 weeks.
c) the mode of administration: one-on-one sessions with a psychologist.
d) the topics covered: managing emotions, uncertainty and unhelpful meta-cognitions.
Intervention code [1] 241256 0
Treatment: Other
Comparator / control treatment
This is a single-group-trial research in which the same treatment is applied to all subjects.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240887 0
Mean Worry Severity Score as assessed on the Penn State Worry Scale (PSWQ). The PSWQ is a 16-item measure for capturing the excessive and uncontrollable nature of pathological worry, where higher scores indicate more severe worry.
Timepoint [1] 240887 0
at baseline; at 3, 6, 9 and 12 weeks after treatment commencement; and at 4 and 12 weeks after the completion of the treatment.
Primary outcome [2] 240888 0
Clinician Severity Rating of GAD as assessed on the Anxiety Disorders Interview Schedule - IV (ADIS-IV). The ADIS-IV is a semi-structured interview that assesses for DSM-IV (Diagnostic & Statistical Manual of Mental Disorders, 4th edition) anxiety, mood, somatoform, and substance use disorders, and screens for the presence of other conditions (e.g. psychotic disorders).
Timepoint [2] 240888 0
at baseline, 12 weeks after treatment commencement, and 12 weeks after completion of treatment.
Secondary outcome [1] 257569 0
Mean score of the Difficulties in Emotion Regulation Scale. This scale assesses emotion regulation deficits across six dimensions: emotional awareness, emotional clarity, nonacceptance of emotions, difficulty engaging in goal-directed behaviour, poor impulse control, and limited access to emotion regulation strategies.
Timepoint [1] 257569 0
at baseline; at 3, 6, 9 and 12 weeks after treatment commencement; and at 4 and 12 weeks after the completion of the treatment.

Eligibility
Key inclusion criteria
Patients must be 18 years old or older, and must meet the DSM-VI criteria for a primary diagnosis of GAD as assessed on the ADIS-IV.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are psychotic, suicidal or have significant substance abuse problems.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
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)
Recruitment postcode(s) [1] 2072 0
2109

Funding & Sponsors
Funding source category [1] 243718 0
University
Name [1] 243718 0
Macquarie University
Address [1] 243718 0
Balaclava Road,
North Ryde,
New South Wales 2109
Country [1] 243718 0
Australia
Primary sponsor type
Individual
Name
Hock Lai CHOO, Christopher
Address
4/48 Harold St,
North Parramatta,
NSW 2151
Country
Australia
Secondary sponsor category [1] 237081 0
Individual
Name [1] 237081 0
Dr Andrew Baillie
Address [1] 237081 0
Department of Psychology,
Macquarie University.
Balaclava Road,
North Ryde,
NSW 2109
Country [1] 237081 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243847 0
Ethics committee address [1] 243847 0
Ethics committee country [1] 243847 0
Date submitted for ethics approval [1] 243847 0
10/08/2009
Approval date [1] 243847 0
Ethics approval number [1] 243847 0
HE28AUG2009-D00103

Summary
Brief summary
Generalized Anxiety Disorder (GAD) is a disabling disorder characterized by the central defining feature of pervasive, excessive and uncontrollable worry. Although the traditional Cognitive Behavioural Therapy (CBT) has been found to be effective for GAD patients, a significant proportion of these patients fail to achieve high end-state functioning. Recent research evidence have found GAD to be associated with a person's intolerance of uncertainty, unhelpful meta-cognitions, and deficits in emotional regulation. The current study thus aims to investigate the efficacy of an enhanced CBT treatment that teaches GAD patients skills in managing emotions, uncertainty and unhelpful meta-cognitions, in addition to the usual CBT skills. It is hypothesized that GAD-related symptoms in the patients will improve with the enhanced CBT treatment and the change of symptoms will be related to change in scores (baseline to post-treatment) in one or more of the aforesaid factors (i.e. emotion regulation, meta-cognitions and/or intolerance of uncertainty).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30269 0
Address 30269 0
Country 30269 0
Phone 30269 0
Fax 30269 0
Email 30269 0
Contact person for public queries
Name 13516 0
Hock Lai CHOO, Christopher
Address 13516 0
Department of Psychology,
Macquarie University.
Balaclava Road,
North Ryde,
NSW 2109
Country 13516 0
Australia
Phone 13516 0
+61 412 009 676
Fax 13516 0
Email 13516 0
hock-lai.choo@students.mq.edu.au
Contact person for scientific queries
Name 4444 0
Hock Lai CHOO, Christopher
Address 4444 0
Department of Psychology,
Macquarie University.
Balaclava Road,
North Ryde,
NSW 2109
Country 4444 0
Australia
Phone 4444 0
+61 412 009 676
Fax 4444 0
Email 4444 0
hock-lai.choo@students.mq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results