Phobia, SocialNCT03630783
Combined CBM For Social Anxiety in Turkey
A study testing Combined Cognitive Bias Modification in people with Phobia, Social, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phobia, Social
- What is being tested?
- Combined Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scoring above 68 on the Liebowitz Social Anxiety Scale
Who cannot join
- Having any psychiatric disorder
- Receiving a psychiatric/psychological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Cognitive Bias Modification for Social Anxiety: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Combined Cognitive Bias Modification
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Cognitive Bias ModificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Combined Cognitive Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (16)
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.
Measured: Day 0, pre-intervention
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.
Measured: 4 weeks
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.
Measured: 12 weeks
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.
Measured: Day 0, pre-intervention
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.
Measured: 4 weeks
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.
Measured: 12 weeks
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.
Measured: Day 0, pre-intervention
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.
Measured: 4 weeks
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.
Measured: 12 weeks
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.
Measured: Day 0, pre-intervention
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.
Measured: 4 weeks
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.
Measured: 12 weeks
Attentional bias
Attentional bias was assessed with the Posner paradigm
Measured: Day 0, pre-intervention
Attentional bias
Attentional bias was assessed with the Posner paradigm
Measured: 4 weeks
Interpretational bias
Interpretational bias was assessed with the Word Sentence Association Paradigm
Measured: Day 0, pre-intervention
Interpretational bias
Interpretational bias was assessed with the Word Sentence Association Paradigm
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study startMar 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobia, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Volkan Koç, Istanbul Sabahattin Zaim University
- Investigators
- Volkan Koç, PhD, Study chair, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630783
- Sponsor's protocol ID
- IstanbulSZU
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cognitive Bias Modification for Social Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03630783
- Acronym / sponsor ID
- IstanbulSZU
- Conditions
- Phobia, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Modification (Group-E) | Experimental | Behavioral: Combined Cognitive Bias ModificationParticipants 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. |
| Placebo Control (Group-C) | Placebo comparator | Behavioral: Combined Cognitive Bias ModificationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scoring above 68 on the Liebowitz Social Anxiety Scale
Key exclusion criteria (2 listed)
- Having any psychiatric disorder
- Receiving a psychiatric/psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Cognitive Bias Modification | Behavioural | Cognitive Bias Modification (Group-E), Placebo Control (Group-C) |
Primary outcome
Social anxiety
Time frame: Day 0, pre-intervention
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
Time frame: 4 weeks
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
Time frame: 12 weeks
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.
16 secondary outcomes
Depression
Time frame: Day 0, pre-intervention
Depression
Time frame: 4 weeks
Depression
Time frame: 12 weeks
Anxiety
Time frame: Day 0, pre-intervention
Anxiety
Time frame: 4 weeks
Anxiety
Time frame: 12 weeks
Automatic Thoughts Questionnaire
Time frame: Day 0, pre-intervention
Automatic Thoughts Questionnaire
Time frame: 4 weeks
Automatic Thoughts Questionnaire
Time frame: 12 weeks
Dysfunctional Attitudes
Time frame: Day 0, pre-intervention
Dysfunctional Attitudes
Time frame: 4 weeks
Dysfunctional Attitudes
Time frame: 12 weeks
Attentional bias
Time frame: Day 0, pre-intervention
Attentional bias
Time frame: 4 weeks
Interpretational bias
Time frame: Day 0, pre-intervention
Interpretational bias
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volkan Koç, PhD study chair
Istanbul Sabahattin Zaim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Cognitive Bias Modification in people with Phobia, Social, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social anxiety (time frame: Day 0, pre-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.