Social Anxiety DisorderNCT03101553
Computerized Treatment for Social Anxiety
A study testing Interpretation Bias Modification and Progressive Muscle Relaxation in people with Social Anxiety Disorder, run by Florida State University at 1 site in United States.
Trial summary
The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Interpretation Bias Modification and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 1 Nov 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of Social Anxiety Disorder according to DSM-5 criteria
- SPIN score greater than or equal to 30
- Must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation))
Who cannot join
- Concurrent psychotherapy or treatment for social anxiety disorder
- Clinically significant suicidality
- Current Alcohol Use Disorder of "Severe" severity or higher
- Current Non-alcohol Substance Use Disorder of "Moderate" severity or higher
- Recent changes (less than four weeks) in psychiatric medication
- History of psychotic symptoms
- May not have participated in a similar computerized treatment program
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University, Department of Psychology
Tallahassee, Florida, 32306
About this study
The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) The effects of condition will be maintained at the 3-month follow-up assessment.
- Conditions
- Social Anxiety Disorder
- Being tested
- Interpretation Bias Modification, Progressive Muscle Relaxation
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation Bias ModificationBehavioural
Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.
Progressive Muscle RelaxationBehavioural
Eight 15-minute sessions of progressive muscle relaxation (PMR).
| Study group | Role | What they receive |
|---|---|---|
| Interpretation Bias Modification | Experimental | Treatment consists of eight brief sessions consisting of two tasks. In Task 1, participants read unique scenarios ("You notice someone pointing in your direction"). A sentence meant to resolve the ambiguity will appear ("This person thinks they reco_nize you"). After filling in the missing letter, the interpretation is reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is this person mocking you?"). In Task 2, participants are shown a word denoting a threatening ("mocking") or benign ("cheerful") interpretation. Participants are presented with an ambiguous scenario ("You hear people at a nearby table laughing") and asked to denote whether the word and the sentence are related. Participants will receive feedback based on their response. Receives: Behavioral: Interpretation Bias Modification |
| Progressive Muscle Relaxation | Active comparator | Participants will receive eight brief sessions of PMR. They will listen to a PMR script (Kassinove \& Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release different muscle groups. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Phobia Inventory (SPIN; Davidson, 1995)
Measures past-week social anxiety symptom severity
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Secondary outcomes (3)
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Measures depressive symptom severity
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Measure anxious symptom severity
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)
Measure of strength of evaluation related threat interpretation bias
Measured: change from baseline at one-week post treatment and 3-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start10 Feb 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101553
- Sponsor's protocol ID
- 2016.20077
- Other IDs
- 2016
- Status last verified
- Jan 2021
- First submitted
- 30 Mar 2017
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Treatment for Social Anxiety
- ClinicalTrials.gov ID
- NCT03101553
- Acronym / sponsor ID
- 2016.20077
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 5 Apr 2017 (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.
The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) The effects of condition will be maintained at the 3-month follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpretation Bias Modification | Experimental | Behavioral: Interpretation Bias ModificationTreatment consists of eight brief sessions consisting of two tasks. In Task 1, participants read unique scenarios ("You notice someone pointing in your direction"). A sentence meant to resolve the ambiguity will appear ("This person thinks they reco_nize you"). After filling in the missing letter, the interpretation is reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is this person mocking you?"). In Task 2, participants are shown a word denoting a threatening ("mocking") or benign ("cheerful") interpretation. Participants are presented with an ambiguous scenario ("You hear people at a nearby table laughing") and asked to denote whether the word and the sentence are related. Participants will receive feedback based on their response. |
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle RelaxationParticipants will receive eight brief sessions of PMR. They will listen to a PMR script (Kassinove \& Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release different muscle groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current diagnosis of Social Anxiety Disorder according to DSM-5 criteria
- SPIN score greater than or equal to 30
- Must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation))
Key exclusion criteria (7 listed)
- Concurrent psychotherapy or treatment for social anxiety disorder
- Clinically significant suicidality
- Current Alcohol Use Disorder of "Severe" severity or higher
- Current Non-alcohol Substance Use Disorder of "Moderate" severity or higher
- Recent changes (less than four weeks) in psychiatric medication
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 |
|---|---|---|
| Interpretation Bias ModificationEight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation. | Behavioural | Interpretation Bias Modification |
| Progressive Muscle RelaxationEight 15-minute sessions of progressive muscle relaxation (PMR). | Behavioural | Progressive Muscle Relaxation |
Primary outcome
Social Phobia Inventory (SPIN; Davidson, 1995)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
Measures past-week social anxiety symptom severity
3 secondary outcomes
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)
Time frame: change from baseline at one-week post treatment and 3-months post-treatment
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 29 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation Bias Modification and Progressive Muscle Relaxation in people with Social Anxiety Disorder, run by Florida State University at 1 site in United States.
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 3 inclusion and 7 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 29 Jan 2021. 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 United States. 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. 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 Phobia Inventory (SPIN; Davidson, 1995) (time frame: change from baseline at one-week post treatment and 3-months post-treatment). 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 29 Jan 2021.