Clinical trial NCT03630783: Combined CBM For Social Anxiety in Turkey
Official title: Combined Cognitive Bias Modification for Social Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phobia, Social
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2018-08-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Scoring above 68 on the Liebowitz Social Anxiety Scale

Exclusion Criteria:

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

Primary outcomes:
measure: Social anxiety
timeFrame: Day 0, pre-intervention
measure: Social anxiety
timeFrame: 4 weeks
measure: Social anxiety
timeFrame: 12 weeks
Secondary outcomes:
measure: Depression
timeFrame: Day 0, pre-intervention
measure: Depression
timeFrame: 4 weeks
measure: Depression
timeFrame: 12 weeks
measure: Anxiety
timeFrame: Day 0, pre-intervention
measure: Anxiety
timeFrame: 4 weeks
measure: Anxiety
timeFrame: 12 weeks
measure: Automatic Thoughts Questionnaire
timeFrame: Day 0, pre-intervention
measure: Automatic Thoughts Questionnaire
timeFrame: 4 weeks
measure: Automatic Thoughts Questionnaire
timeFrame: 12 weeks
measure: Dysfunctional Attitudes
timeFrame: Day 0, pre-intervention
measure: Dysfunctional Attitudes
timeFrame: 4 weeks
measure: Dysfunctional Attitudes
timeFrame: 12 weeks
measure: Attentional bias
timeFrame: Day 0, pre-intervention
measure: Attentional bias
timeFrame: 4 weeks
measure: Interpretational bias
timeFrame: Day 0, pre-intervention
measure: Interpretational bias
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Küçükçekmece
country: Turkey
facility: Volkan Koç
state: İstanbul
Study officials:
affiliation: Istanbul Sabahattin Zaim University
name: Volkan Koç, PhD
role: STUDY_CHAIR
References: