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Combined CBM For Social Anxiety in Turkey

Primary Purpose

Phobia, Social

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combined Cognitive Bias Modification
Sponsored by
Istanbul Sabahattin Zaim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phobia, Social

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Scoring above 68 on the Liebowitz Social Anxiety Scale

Exclusion Criteria:

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

Sites / Locations

  • Volkan Koç

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive Bias Modification (Group-E)

Placebo Control (Group-C)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Attentional bias
Attentional bias was assessed with the Posner paradigm
Attentional bias
Attentional bias was assessed with the Posner paradigm
Interpretational bias
Interpretational bias was assessed with the Word Sentence Association Paradigm
Interpretational bias
Interpretational bias was assessed with the Word Sentence Association Paradigm

Full Information

First Posted
August 2, 2018
Last Updated
August 17, 2018
Sponsor
Istanbul Sabahattin Zaim University
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03630783
Brief Title
Combined CBM For Social Anxiety in Turkey
Official Title
Combined Cognitive Bias Modification for Social Anxiety: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sabahattin Zaim University
Collaborators
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobia, Social

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Bias Modification (Group-E)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Control (Group-C)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Combined Cognitive Bias Modification
Primary Outcome Measure Information:
Title
Social anxiety
Description
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.
Time Frame
Day 0, pre-intervention
Title
Social anxiety
Description
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.
Time Frame
4 weeks
Title
Social anxiety
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
Day 0, pre-intervention
Title
Depression
Description
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.
Time Frame
4 weeks
Title
Depression
Description
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.
Time Frame
12 weeks
Title
Anxiety
Description
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.
Time Frame
Day 0, pre-intervention
Title
Anxiety
Description
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.
Time Frame
4 weeks
Title
Anxiety
Description
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.
Time Frame
12 weeks
Title
Automatic Thoughts Questionnaire
Description
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.
Time Frame
Day 0, pre-intervention
Title
Automatic Thoughts Questionnaire
Description
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.
Time Frame
4 weeks
Title
Automatic Thoughts Questionnaire
Description
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.
Time Frame
12 weeks
Title
Dysfunctional Attitudes
Description
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.
Time Frame
Day 0, pre-intervention
Title
Dysfunctional Attitudes
Description
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.
Time Frame
4 weeks
Title
Dysfunctional Attitudes
Description
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.
Time Frame
12 weeks
Title
Attentional bias
Description
Attentional bias was assessed with the Posner paradigm
Time Frame
Day 0, pre-intervention
Title
Attentional bias
Description
Attentional bias was assessed with the Posner paradigm
Time Frame
4 weeks
Title
Interpretational bias
Description
Interpretational bias was assessed with the Word Sentence Association Paradigm
Time Frame
Day 0, pre-intervention
Title
Interpretational bias
Description
Interpretational bias was assessed with the Word Sentence Association Paradigm
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Scoring above 68 on the Liebowitz Social Anxiety Scale Exclusion Criteria: Having any psychiatric disorder Receiving a psychiatric/psychological treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Koç, PhD
Organizational Affiliation
Istanbul Sabahattin Zaim University
Official's Role
Study Chair
Facility Information:
Facility Name
Volkan Koç
City
Küçükçekmece
State/Province
İstanbul
ZIP/Postal Code
34303
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Combined CBM For Social Anxiety in Turkey

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