Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT

NCT01570400 | Completed

• 1 other identifier: SOFIE13a
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces symptoms of social phobia among a population diagnosed with this disorder.

Conditions

Social Phobia

Keywords

social phobia; social anxiety; cognitive bias modification

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

  11 weeks

• 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

• 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.

  Two weeks into treatment

Secondary Outcomes (15)

• Change from baseline in Quality Of Life Inventory (QOLI)

  24 hours

• Change from baseline in Quality Of Life Inventory (QOLI)

  11 weeks

• Change from baseline in Quality Of Life Inventory (QOLI)

  4 months

• Change from baseline in Quality Of Life Inventory (QOLI)

  2 weeks into treatment

• Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale

  24 hours

Study Arms (2)

CBM training program variant 1 + iCBT

EXPERIMENTAL

Cognitive bias modification training program variant 1 combined with iCBT

Behavioral: Internet-administered cognitive behavioral therapy (iCBT); Behavioral: Cognitive bias modification training program variant 1

CBM training program variant 2 + iCBT

EXPERIMENTAL

Cognitive bias modification training program variant 2 combined with iCBT

Behavioral: Internet-administered cognitive behavioral therapy (iCBT); Behavioral: Cognitive bias modification training program variant 2

Interventions

Internet-administered cognitive behavioral therapy (iCBT) BEHAVIORAL

Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.

CBM training program variant 1 + iCBT; CBM training program variant 2 + iCBT

Cognitive bias modification training program variant 1 BEHAVIORAL

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. Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

CBM training program variant 1 + iCBT

Cognitive bias modification training program variant 2 BEHAVIORAL

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. Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

CBM training program variant 2 + iCBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided
• Diagnosed social phobia (according to DSM-IV criteria)
• Access to computer with internet connection

You may not qualify if:

• Severe depression (and/or suicidal behavior)
• Suffer from other severe psychiatric condition (e.g. psychosis)
• Non-stable use of medication (3 months stable dosage)
• Undergoing other, parallel psychological treatment

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of Psychology, Umeå University

Umeå, Västerbotten County, 90187, Sweden

Location

Related Publications (2)

• Boettcher J, Andersson G, Carlbring P; SOFIE-13 Research Group. Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial. Trials. 2013 Mar 8;14:68. doi: 10.1186/1745-6215-14-68.

  PMID: 23497513 BACKGROUND

• Boettcher J, Hasselrot J, Sund E, Andersson G, Carlbring P. Combining attention training with internet-based cognitive-behavioural self-help for social anxiety: a randomised controlled trial. Cogn Behav Ther. 2014;43(1):34-48. doi: 10.1080/16506073.2013.809141. Epub 2013 Jul 30.

  PMID: 23898817 RESULT

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Per Carlbring, Professor

  Department of Psychology, Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 4, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

SE (1)