Combined CBM For Social Anxiety in Turkey

Phobia, Social Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630783
• Other study ID #: IstanbulSZU
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2018
• Source: Istanbul Sabahattin Zaim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scoring above 68 on the Liebowitz Social Anxiety Scale

Exclusion Criteria:

• Having any psychiatric disorder

• Receiving a psychiatric/psychological treatment

Related Conditions & MeSH terms

• Phobia, Social

Intervention

Behavioral:
• Combined Cognitive Bias Modification

Locations

Country	Name	City	State
Turkey	Volkan Koç	Küçükçekmece	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Sabahattin Zaim University	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Attentional bias	Attentional bias was assessed with the Posner paradigm	Day 0, pre-intervention
Secondary	Attentional bias	Attentional bias was assessed with the Posner paradigm	4 weeks
Secondary	Interpretational bias	Interpretational bias was assessed with the Word Sentence Association Paradigm	Day 0, pre-intervention
Secondary	Interpretational bias	Interpretational bias was assessed with the Word Sentence Association Paradigm	4 weeks