Combined CBM For Social Anxiety in Turkey

NCT ID: NCT03630783

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-06-30

Brief 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.

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.

Conditions

Phobia, Social

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Combined Cognitive Bias Modification

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Combined Cognitive Bias Modification

Intervention Type: BEHAVIORAL

Interventions

Combined Cognitive Bias Modification

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Scoring above 68 on the Liebowitz Social Anxiety Scale

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Istanbul Sabahattin Zaim University

OTHER

Sponsor Role: lead

Responsible Party

Volkan Koç

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Volkan Koç, PhD

Role: STUDY_CHAIR

Istanbul Sabahattin Zaim University

Locations

Volkan Koç

Küçükçekmece, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IstanbulSZU

Identifier Type: -

Identifier Source: org_study_id