RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
A Randomised, Triple Blind, Placebo-controlled Trial Comparing the Effects of Cognitive Therapy, Paroxetine and Both Cognitive Therapy and Paroxetine in the Treatment of Patients With Primary Social Phobia
1 other identifier
interventional
86
1 country
1
Brief Summary
We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological mechanisms in the patients' response to CT, to paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. The first group (N=25) will be treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo and clinical management (N=25). All patients will have 12 weeks of treatment in the acute phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The 4th group will have placebo for 24 weeks and clinical management. The patients will be assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12 weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months. Measures are based on all three main sources; self-report inventories, clinical assessments by independent raters and psycho-physiological assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 27, 2018
August 1, 2018
5.2 years
September 9, 2005
August 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.
December 2010
A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.
December 2010
Secondary Outcomes (1)
Relapse rate during 6 and 12 months of follow up.
December 2010
Study Arms (4)
Cognitive Therapy
ACTIVE COMPARATORCognitive Therapy
Seroxat and SE
ACTIVE COMPARATORSSRI with Self exposure
Seroxat and Cognitive Therapy
ACTIVE COMPARATORCombination of Seroxat and Cognitive Therapy
Pill-Placebo
PLACEBO COMPARATORPill Placebo
Interventions
Seroxat was administered over 24 weeks 20-50 mg/d, and Cognitive therapy was provided over 12 weeks. The patients were assessed at pre, post and 1 yrs follow up
Eligibility Criteria
You may qualify if:
- Signed written informed consent obtained prior to entry in the study.
- Diagnosed with primary social phobia, generalized or specific (DSM-IV, APA, 1994).
- Symptoms present at least one year.
- Age between 18-65 years.
You may not qualify if:
- Known somatic diseases.
- Pregnant (\*) or lactating women.
- Psychosis
- Acute suicidal symptoms
- Major depressive disorder
- Generalized Anxiety Disorder or PTSD
- Cluster A or cluster B personality disorder
- Substance abuse or dependence
- Body dysmorphic disorder.
- Not willing to accept random allocation.
- Patients who take some form of SSRI medications currently or during the last 6 months
- Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial or are taking herbal remedies that may be hazardous or inflict treatment response.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
Dept. of Psychology, NTNU
Trondheim, Dragvoll, 7491, Norway
Related Publications (2)
Nordahl HM, Vogel PA, Morken G, Stiles TC, Sandvik P, Wells A. Paroxetine, Cognitive Therapy or Their Combination in the Treatment of Social Anxiety Disorder with and without Avoidant Personality Disorder: A Randomized Clinical Trial. Psychother Psychosom. 2016;85(6):346-356. doi: 10.1159/000447013. Epub 2016 Oct 15.
PMID: 27744447RESULTNordahl H, Nordahl HM, Hjemdal O, Wells A. Cognitive and metacognitive predictors of symptom improvement following treatment for social anxiety disorder: A secondary analysis from a randomized controlled trial. Clin Psychol Psychother. 2017 Nov;24(6):1221-1227. doi: 10.1002/cpp.2083. Epub 2017 Mar 15.
PMID: 28295802RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans M Nordahl, Professor
Norwegian University of Science and Technology, NTNU
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
October 1, 2004
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
August 27, 2018
Record last verified: 2018-08