Combined CBM For Social Anxiety in Turkey

NCT03630783 | Completed

• 1 other identifier: IstanbulSZU
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobia, Social

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Depression

  Day 0, pre-intervention

• Depression

  4 weeks

• Depression

  12 weeks

• Anxiety

  Day 0, pre-intervention

• Anxiety

  4 weeks

Study Arms (2)

Cognitive Bias Modification (Group-E)

EXPERIMENTAL

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 Control (Group-C)

PLACEBO COMPARATOR

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

Interventions

Combined Cognitive Bias Modification BEHAVIORAL

Cognitive Bias Modification (Group-E); Placebo Control (Group-C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scoring above 68 on the Liebowitz Social Anxiety Scale

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead
• Hacettepe University: collaborator

Study Sites (1)

Volkan Koç

Küçükçekmece, Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Volkan Koç, PhD

  Istanbul Sabahattin Zaim University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 15, 2018
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

TU (1)