Combined CBM For Social Anxiety in Turkey

Combined Cognitive Bias Modification for Social Anxiety: A Randomized Controlled Trial

In this study, it was examined whether or not combined attentional and interpretational bias modifications with university students who display social anxiety symptoms may lead to a decrease in social anxiety-related complaints. The study was conducted with 84 participants who were university students displaying social anxiety symptoms. The participants were randomly assigned into two conditions; cognitive bias modification group (E) and placebo-control group (C). Participants in group-E were subjected to attentional and interpretational bias modifications twice a week, eight sessions in total. Participants in group-C were subjected to a similar process, but without any modification. The levels of social anxiety, anxiety, depression, nonfunctional thinking of the participants were evaluated three times; just before the first session, just after the last session and two months after the last session. In addition, levels of attentional and interpretational bias of the participants were evaluated twice, just before the first session and just after the last session.

Study Overview

• Status: Completed
• Conditions: Phobia, Social
• Intervention / Treatment: Behavioral: Combined Cognitive Bias Modification

Detailed Description

A 2 (group: experimental, control) × 3 (time: pretest, posttest, follow-up) experimental design was employed. All participants were presented with informed consent form beforehand, and also verbally informed about the procedure. They were assigned to experimental (E) or attention placebo control (C) groups for 2 sessions per week, 8 sessions in total. Before the first session (pretest) and after the last session (posttest), participants were asked to answer self-report questionnaires, and their attentional and interpretational biases were assessed. And finally, participants were asked only to answer to the same questionnaires for the follow up measurements after two months.

Chi square test and independent t-test for dependent variables were run beforehand to check if participants were equally distributed to Bias Modification group-E and group-C. No statistically significant difference between group-E and group-C was observed with regards to gender distribution, social anxiety, anxiety, depression, dysfunctional thoughts, automatic thoughts, and attentional and interpretational biases.

To see the effect of 8 sessions of manipulation on attentional and interpretational bias (independent variable) created a significant difference between experimental and control groups, 2 (group: experimental [E] and control [C]) × 3 (time: pre [t1] / post [t2] / follow-up [t3]) mixed ANOVA was conducted for each dependent variable in self-report measurements, and 2 (group: experimental [E] and control [C]) × 2 (time: pre [t1] / post [t2]) mixed ANOVA were conducted for attentional and interpretational biases.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Küçükçekmece, İstanbul, Turkey, 34303
      • Volkan Koç

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scoring above 68 on the Liebowitz Social Anxiety Scale

Exclusion Criteria:

• Having any psychiatric disorder
• Receiving a psychiatric/psychological treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Bias Modification (Group-E); Participants were subjected to Combined Cognitive Bias Modification in each session. During the attentional bias modification phase, photographs of neutral or threatening (disgusted) faces were used. In each trial, a pair was shown for 500 ms. Then, a sign of arrow appeared and participants were asked to indicate the direction of the arrow. In %80 of the trials, the arrow was in the same area with the neutral photograph. During the interpretational bias modification phase a threatening or positive word, as the interpretation of a sentence, appeared, then, a relevant sentence with ambiguous meaning appeared, and later, participants were asked to indicate if the word and the sentence were related. After their response a feedback (right/wrong) was given and the next trial was started.	Behavioral: Combined Cognitive Bias Modification
Placebo Comparator: Placebo Control (Group-C); Participants in this group were subjected to the same procedure as the experimental group. However, during the Combined Cognitive Bias Modification process, the sign of arrow appeared at even rates (%50 - %50) after neutral and disgusted facial impressions; and during the interpretational bias modification, sentences and relevant words were superficially related or were not related at all.	Behavioral: Combined Cognitive Bias Modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social anxiety	Social anxiety symptoms were assessed with the Turkish version of the Liebowitz Social Anxiety Scale. The scale constitutes of 48 items. The lowest possible score is 48 and highest score is 192. Higher scores indicate a worse outcome.	Day 0, pre-intervention
Social anxiety	Social anxiety symptoms were assessed with the Turkish version of the Liebowitz Social Anxiety Scale. The scale constitutes of 48 items. The lowest possible score is 48 and highest score is 192. Higher scores indicate a worse outcome.	4 weeks
Social anxiety	Social anxiety symptoms were assessed with the Turkish version of the Liebowitz Social Anxiety Scale. The scale constitutes of 48 items. The lowest possible score is 48 and highest score is 192. Higher scores indicate a worse outcome.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Depression symptoms were assessed with the Turkish version of the Beck Depression Inventory. The scale constitutes of 21 items. The lowest possible score is 0 and highest score is 63. Higher scores indicate a worse outcome.	Day 0, pre-intervention
Depression	Depression symptoms were assessed with the Turkish version of the Beck Depression Inventory. The scale constitutes of 21 items. The lowest possible score is 0 and highest score is 63. Higher scores indicate a worse outcome.	4 weeks
Depression	Depression symptoms were assessed with the Turkish version of the Beck Depression Inventory. The scale constitutes of 21 items. The lowest possible score is 0 and highest score is 63. Higher scores indicate a worse outcome.	12 weeks
Anxiety	Anxiety symptoms were assessed with the Turkish version of the Beck Anxiety Inventory. The scale constitutes of 21 items. The lowest possible score is 0 and highest score is 63. Higher scores indicate a worse outcome.	Day 0, pre-intervention
Anxiety	Anxiety symptoms were assessed with the Turkish version of the Beck Anxiety Inventory. The scale constitutes of 21 items. The lowest possible score is 0 and highest score is 63. Higher scores indicate a worse outcome.	4 weeks
Anxiety	Anxiety symptoms were assessed with the Turkish version of the Beck Anxiety Inventory. The scale constitutes of 21 items. The lowest possible score is 0 and highest score is 63. Higher scores indicate a worse outcome.	12 weeks
Automatic Thoughts Questionnaire	Automatic thoughts were assessed with the Turkish version of the Automatic Thoughts Questionnaire. The scale constitutes of 30 items. The lowest possible score is 30 and highest score is 150. Higher scores indicate a worse outcome.	Day 0, pre-intervention
Automatic Thoughts Questionnaire	Automatic thoughts were assessed with the Turkish version of the Automatic Thoughts Questionnaire. The scale constitutes of 30 items. The lowest possible score is 30 and highest score is 150. Higher scores indicate a worse outcome.	4 weeks
Automatic Thoughts Questionnaire	Automatic thoughts were assessed with the Turkish version of the Automatic Thoughts Questionnaire. The scale constitutes of 30 items. The lowest possible score is 30 and highest score is 150. Higher scores indicate a worse outcome.	12 weeks
Dysfunctional Attitudes	Dysfunctional beliefs were assessed with the Turkish version of the Dysfunctional Attitude Scale. The scale constitutes of 40 items. The lowest possible score is 40 and highest score is 280. Higher scores indicate a worse outcome.	Day 0, pre-intervention
Dysfunctional Attitudes	Dysfunctional beliefs were assessed with the Turkish version of the Dysfunctional Attitude Scale. The scale constitutes of 40 items. The lowest possible score is 40 and highest score is 280. Higher scores indicate a worse outcome.	4 weeks
Dysfunctional Attitudes	Dysfunctional beliefs were assessed with the Turkish version of the Dysfunctional Attitude Scale. The scale constitutes of 40 items. The lowest possible score is 40 and highest score is 280. Higher scores indicate a worse outcome.	12 weeks
Attentional bias	Attentional bias was assessed with the Posner paradigm	Day 0, pre-intervention
Attentional bias	Attentional bias was assessed with the Posner paradigm	4 weeks
Interpretational bias	Interpretational bias was assessed with the Word Sentence Association Paradigm	Day 0, pre-intervention
Interpretational bias	Interpretational bias was assessed with the Word Sentence Association Paradigm	4 weeks

Collaborators and Investigators

• Sponsor: Istanbul Sabahattin Zaim University
• Collaborators: Hacettepe University
• Investigators: Study Chair: Volkan Koç, PhD, Istanbul Sabahattin Zaim University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Phobia, Social
• Other Study ID Numbers: IstanbulSZU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No