NCT02590770

Brief Summary

The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (SAD)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

October 27, 2015

Last Update Submit

July 27, 2016

Conditions

Phobia, Social

Outcome Measures

Primary Outcomes (1)

  • Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores

    The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern. It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability.

    post treatment (1 week after treatment completion) and 3-month follow up

Secondary Outcomes (1)

  • Change from baseline - the Social Phobia Inventory scores

    post treatment (1 week after treatment completion) and 3-month follow up

Other Outcomes (1)

  • changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis

    post treatment (1 week after treatment completion)

Study Arms (2)

gaze-contingent

ACTIVE COMPARATOR

attention modification: participants will receive gaze-contingent feedback according to their viewing patterns

Behavioral: attention modification

non-gaze contingent

PLACEBO COMPARATOR

Placebo: participants will receive non-gaze-contingent feedback according to their viewing patterns

Other: Placebo

Interventions

attention modificationBEHAVIORAL

participants will receive gaze-continent feedback according to their viewing patterns

gaze-contingent
PlaceboOTHER

participants will receive non-gaze-continent feedback unrelated to their viewing patterns

non-gaze contingent

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A signed consent form
  • Men and women between the ages of 18 and 60.
  • Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
  • A minimum of a 1-year duration of SP
  • SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
  • Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.

You may not qualify if:

  • Psychotic episode in the past or the present time.
  • Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
  • Another psychotherapeutic treatment during the study.
  • Usage of neuroleptic medication.
  • Change in medication status during the study.
  • Substantial usage of drugs or alcohol in the present time.
  • Poor judgment capacity (i.e., children under 18 and special populations).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

Location

Related Publications (1)

  • Lazarov A, Pine DS, Bar-Haim Y. Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. Am J Psychiatry. 2017 Jul 1;174(7):649-656. doi: 10.1176/appi.ajp.2016.16080894. Epub 2017 Jan 20.

    PMID: 28103714DERIVED

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Yair Bar-Haim, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 29, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

IL(1)