Social PhobiaPhase 2/3NCT00326430
Residential Cognitive and Interpersonal Therapy for Social Phobia
A Phase 2/3 study testing Cognitive Therapy, Interpersonal Therapy in people with Social Phobia, run by Modum Bad at 1 site in Norway.
Trial summary
The purpose of this study is twofold: (1) to compare the effectiveness of two promising treatments for social phobia, a new cognitive therapy model (Clark \& Wells, 1995; Borge et al., 2001) and interpersonal therapy (Lipsitz, Markowitz, \& Cherry, 1997), adapted for inpatient groups; and (2) to study the empirical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- Cognitive Therapy, Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2001to Jun 2004
- Phase
- Phase 2/3
- 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
- DSM-IV criteria for social phobia
- the patient consider social phobia as the main current problem
- willingness to suspend use of psychotropic medication, alcohol and other substances
- acceptance of random allocation
- ability to speak Norwegian
- age 18-65 years.
Who cannot join
- a history of recurrent major depression currently treated sucessfully with antidepressant medications
- has immediate need for additional treatment
- current psychotic disorder or substance abuse
- organic mental disorder
- previously treated with similar models
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Residential Cognitive Therapy Versus Residential Interpersonal Therapy for Social Phobia: A Randomized Controlled Trial
The purpose of this study is twofold: (1) to compare the effectiveness of two promising treatments for social phobia, a new cognitive therapy model (Clark \& Wells, 1995; Borge et al., 2001) and interpersonal therapy (Lipsitz, Markowitz, \& Cherry, 1997), adapted for inpatient groups; and (2) to study the empirical change processes in these therapies and compare them with the cognitive and interpersonal models of change.
Read the detailed description
Social phobia typically leads to severe impairment in work and other social life, and - without treatment - it can persist for decades. Given its prevalence, severity, and chronicity, effective treatment methods are strongly needed. However, traditional psychological and pharmacological treatments have had statistically significant, but clinically limited effects (Taylor, 1996).
Based on an empirical analysis of the cognitive processes in social phobia, Clark and Wells (1995) have developed a new cognitive model. Cognitive therapy (CT) derived from this model has been found to be superior to a combination of fluoxetine and self-exposure (Clark et al., 2003).
Social phobic symptoms may be viewed as a result of more general interpersonal difficulties and interpersonal psychotherapy (IPT) can be a reasonable alternative for social phobia (Lipsitz \& Markowitz, 1996). A clinical case series indicates that social phobic patients improve during interpersonal psychotherapy for social phobia (IPT-SP; Lipsitz et al., 1999.
- Conditions
- Social Phobia
- Being tested
- Cognitive Therapy, Interpersonal Therapy
- Keywords
- Social Phobia, Cognitive Therapy, Interpersonal Therapy, Efficacy, Process-Outcome
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Therapy, Interpersonal TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Avoidance
Social Anxiety
Secondary outcomes (4)
General Anxiety
Depression
Interpersonal Problems
Personality Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startOct 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Investigators
- Asle Hoffart, Dr Psychol, Study chair, Modum BadFinn-Magnus Borge, Cand Psychol, Principal investigator, Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326430
- Sponsor's protocol ID
- 1
- Status last verified
- May 2006
- First submitted
- 15 May 2006
- Last updated
- 16 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residential Cognitive Therapy Versus Residential Interpersonal Therapy for Social Phobia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00326430
- Acronym / sponsor ID
- 1
- Conditions
- Social Phobia
- Keywords
- Social Phobia, Cognitive Therapy, Interpersonal Therapy, Efficacy, Process-Outcome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- Jun 2004
- First posted
- 16 May 2006 (estimated)
- 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 purpose of this study is twofold: (1) to compare the effectiveness of two promising treatments for social phobia, a new cognitive therapy model (Clark \& Wells, 1995; Borge et al., 2001) and interpersonal therapy (Lipsitz, Markowitz, \& Cherry, 1997), adapted for inpatient groups; and (2) to study the empirical change processes in these therapies and compare them with the cognitive and interpersonal models of change.
Detailed description
Social phobia typically leads to severe impairment in work and other social life, and - without treatment - it can persist for decades. Given its prevalence, severity, and chronicity, effective treatment methods are strongly needed. However, traditional psychological and pharmacological treatments have had statistically significant, but clinically limited effects (Taylor, 1996).
Based on an empirical analysis of the cognitive processes in social phobia, Clark and Wells (1995) have developed a new cognitive model. Cognitive therapy (CT) derived from this model has been found to be superior to a combination of fluoxetine and self-exposure (Clark et al., 2003).
Social phobic symptoms may be viewed as a result of more general interpersonal difficulties and interpersonal psychotherapy (IPT) can be a reasonable alternative for social phobia (Lipsitz \& Markowitz, 1996). A clinical case series indicates that social phobic patients improve during interpersonal psychotherapy for social phobia (IPT-SP; Lipsitz et al., 1999.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV criteria for social phobia
- the patient consider social phobia as the main current problem
- willingness to suspend use of psychotropic medication, alcohol and other substances
- acceptance of random allocation
- ability to speak Norwegian
Key exclusion criteria (5 listed)
- a history of recurrent major depression currently treated sucessfully with antidepressant medications
- has immediate need for additional treatment
- current psychotic disorder or substance abuse
- organic mental disorder
- previously treated with similar models
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 |
|---|---|---|
| Cognitive Therapy, Interpersonal Therapy | Behavioural | – |
Primary outcome
Social Avoidance
Social Anxiety
4 secondary outcomes
General Anxiety
Depression
Interpersonal Problems
Personality Disorders
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 16 May 2006.
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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.
Asle Hoffart, Dr Psychol study chair
Modum Bad
Finn-Magnus Borge, Cand Psychol principal investigator
Modum Bad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Therapy, Interpersonal Therapy in people with Social Phobia, run by Modum Bad at 1 site in Norway.
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 6 inclusion and 5 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 16 May 2006. 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 Norway. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Avoidance. The study lists 2 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 16 May 2006.