Treatment of Social Phobia With Cognitive Bias Modification

Social Phobia Clinical Trial

Official title:

Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577303
• Other study ID #: Attention training
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: October 29, 2016
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether different internet-based treatment programs, consisting of cognitive bias modification, reduce symptoms of social phobia among a population diagnosed with this disorder.

Description:

Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent provided

• Diagnosed social phobia (according to DSM-IV criteria)

• Access to computer with internet connection, and printer

Exclusion Criteria:

• Severe depression (and/or suicidal behavior)

• Addiction and/or abuse

• Suffer from other severe psychiatric condition (e.g. psychosis)

• Non-stable use of medication

• Undergoing other, parallel psychological treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• Cognitive bias modification training program variant 1
Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session, of one third is the neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word.
• Cognitive bias modification training program variant 2
Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word or face.
• CBM training program variant 3
Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 3. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word.
• CBM training program variant 4
Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.
• Control training variant 1
Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to a pair of words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive word and the more negative word with equal frequency..
• Control training variant 2
Computerized, internet-based control training program, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.

Locations

Country	Name	City	State
Sweden	Department of Psychology, Umeå University	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Boettcher J, Leek L, Matson L, Holmes EA, Browning M, MacLeod C, Andersson G, Carlbring P. Internet-based attention bias modification for social anxiety: a randomised controlled comparison of training towards negative and training towards positive cues. P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.	24 hours	No
Primary	Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.	14 days	No
Primary	Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.	4 months	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.	24 hours	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.	14 days	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.	4 months	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	24 hours	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	14 days	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	4 months	No
Secondary	Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	Self-rated measurements of social anxiety/phobia.	24 hours	No
Secondary	Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	Self-rated measurements of social anxiety/phobia.	14 days	No
Secondary	Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	Self-rated measurements of social anxiety/phobia.	4 months	No