RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo

Phobic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184106
• Other study ID #: SP/NTNU-2005
• Status: Completed
• Phase: Phase 4
• Start date: October 2004
• Est. completion date: December 2010

Study information

• Verified date: August 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Signed written informed consent obtained prior to entry in the study.

2. Diagnosed with primary social phobia, generalized or specific (DSM-IV, APA, 1994).

3. Symptoms present at least one year.

4. Age between 18-65 years.

Exclusion Criteria:

1. Known somatic diseases.

2. Pregnant (*) or lactating women.

3. Psychosis

4. Acute suicidal symptoms

5. Major depressive disorder

6. Generalized Anxiety Disorder or PTSD

7. Cluster A or cluster B personality disorder

8. Substance abuse or dependence

9. Body dysmorphic disorder.

10. Not willing to accept random allocation.

11. Patients who take some form of SSRI medications currently or during the last 6 months

12. 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.

Related Conditions & MeSH terms

• Phobic Disorders

Intervention

Drug:
• Seroxat, Cognitive therapy, Seroxat+ cognitive therapy
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

Locations

Country	Name	City	State
Norway	Dept. of Psychology, NTNU	Trondheim	Dragvoll

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Nordahl 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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion responders as measured by FAIR OF NEGATIVE EVALUATION and SPAI at 12 and 24 week.		December 2010
Primary	A patient is classified as responder if the decrease on FNE is equivalent with or above 40%.		December 2010
Secondary	Relapse rate during 6 and 12 months of follow up.		December 2010