Trial Outcomes & Findings for Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder (NCT NCT01958788)
NCT ID: NCT01958788
Last Updated: 2016-02-23
Results Overview
The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.
COMPLETED
NA
7 participants
Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up
2016-02-23
Participant Flow
The study was approved by Human Research Ethics Committees of Concordia University and the Hôpital du Sacré-Coeur de Montréal. Participants self-referred to the Hôpital du Sacré-Coeur de Montréal anxiety clinic via advertisements placed in a local newspaper. Recruitment occurred between April 2013 to March 2014.
Participant milestones
| Measure |
Cognitive-Behavioural Treatment
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pretreatment to posttreatment (12 weeks) and 6-month Follow-UpThe CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.
Outcome measures
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Pretreatment ADIS-IV
|
5.5 units on a scale
Standard Deviation 0.82
|
|
Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
Posttreatment ADIS-IV
|
3.14 units on a scale
Standard Deviation 1.03
|
|
Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)
6-month follow-up ADIS-IV
|
2.43 units on a scale
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: Pretreatment to posttreatment (12 weeks) and 6-month Follow-UpThe WAQ is a questionnaire assessing self-reported symptoms of GAD. Scores range from 0 to 56, with higher scores indicating greater severity of self-rated GAD symptoms. The measure was used to assess change from baseline in self-reported GAD symptoms (WAQ).
Outcome measures
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
Worry and Anxiety Questionnaire (WAQ)
Pretreatment WAQ
|
38.36 units on a scale
Standard Deviation 5.25
|
|
Worry and Anxiety Questionnaire (WAQ)
Posttreatment WAQ
|
24.36 units on a scale
Standard Deviation 9.06
|
|
Worry and Anxiety Questionnaire (WAQ)
6-month follow-up WAQ
|
25.43 units on a scale
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: Pretreatment to posttreatment (12 weeks) and 6-month Follow-UpThe IUS is a self-report questionnaire assessing intolerance of uncertainty, or the tendency to view uncertainty and its consequences as negative. Scores range from 27 to 135, with higher scores representing greater intolerance of uncertainty. The IUS was used to assess change from baseline in self-reported intolerance of uncertainty.
Outcome measures
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
Intolerance of Uncertainty Scale (IUS)
Pretreatment IUS
|
85.71 units on a scale
Standard Deviation 14.71
|
|
Intolerance of Uncertainty Scale (IUS)
Posttreatment IUS
|
55.00 units on a scale
Standard Deviation 15.55
|
|
Intolerance of Uncertainty Scale (IUS)
6-month follow-up IUS
|
54.29 units on a scale
Standard Deviation 12.30
|
SECONDARY outcome
Timeframe: Pretreatment to posttreatment (12 weeks) and 6-month Follow-UpThe PSWQ is a self-report questionnaire assessing excessive and uncontrollable worry. Scores range from 16 to 80, with greater scores indicating greater worry. The PSWQ was used to evaluate change from baseline in self-reported worry.
Outcome measures
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
Penn State Worry Questionnaire (PSWQ)
Pretreatment PSWQ
|
61.57 units on a scale
Standard Deviation 6.00
|
|
Penn State Worry Questionnaire (PSWQ)
Posttreatment PSWQ
|
50.00 units on a scale
Standard Deviation 8.25
|
|
Penn State Worry Questionnaire (PSWQ)
6-month follow-up PSWQ
|
51.14 units on a scale
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: Pretreatment to posttreatment (12 weeks) and 6-month Follow-UpThe GAD-SBQ is a self-report questionnaire assessing the tendency to use safety behaviours to cope with anxiety, such as reassurance-seeking and overpreparation. Scores range from 18 to 90, with greater scores indicating greater use of safety behaviours. The GA-SBQ was used to evaluate change from baseline in self-reported safety behaviours.
Outcome measures
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
GAD Safety Behaviours Questionnaire (GAD-SBQ)
Pretreatment GAD-SBQ
|
47.00 units on a scale
Standard Deviation 9.95
|
|
GAD Safety Behaviours Questionnaire (GAD-SBQ)
Posttreatment GAD-SBQ
|
32.71 units on a scale
Standard Deviation 5.53
|
|
GAD Safety Behaviours Questionnaire (GAD-SBQ)
6-month follow-up GAD-SBQ
|
36.14 units on a scale
Standard Deviation 5.11
|
SECONDARY outcome
Timeframe: Pretreatment to posttreatment (12 weeks) and 6-month Follow-UpThe BAI is a self-report questionnaire assessing affective, cognitive, and somatic anxiety over the preceding week. Scores range from 0 to 63, with greater scores representing greater self-reported anxiety. The BAI was used to evaluate change from baseline in self-reported anxiety.
Outcome measures
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
Beck Anxiety Inventory (BAI)
Pretreatment BAI
|
23.71 units on a scale
Standard Deviation 10.47
|
|
Beck Anxiety Inventory (BAI)
Posttreatment BAI
|
9.86 units on a scale
Standard Deviation 10.56
|
|
Beck Anxiety Inventory (BAI)
6-month follow-up BAI
|
12.57 units on a scale
Standard Deviation 12.12
|
SECONDARY outcome
Timeframe: Pretreatment to posttreatment (12 weeks) and 6-month Follow-UpThe BDI-II is a self-report questionnaire assessing a variety of depressive symptoms, including low mood, anhedonia, and worthlessness. Scores range from 0 to 63, with greater scores indicating greater depressive symptoms. The BDI-II was used to evaluate change from baseline in self-reported depressive symptoms.
Outcome measures
| Measure |
Cognitive-Behavioural Treatment
n=7 Participants
12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
|
|---|---|
|
Beck Depression Inventory, 2nd Edition (BDI-II)
Pretreatment BDI-II
|
14.71 units on a scale
Standard Deviation 4.39
|
|
Beck Depression Inventory, 2nd Edition (BDI-II)
Posttreatment BDI-II
|
4.00 units on a scale
Standard Deviation 5.69
|
|
Beck Depression Inventory, 2nd Edition (BDI-II)
6-month follow-up BDI-II
|
5.57 units on a scale
Standard Deviation 5.16
|
Adverse Events
Cognitive-Behavioural Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place