Condition category
Mental and Behavioural Disorders
Date applied
19/01/2018
Date assigned
02/02/2018
Last edited
01/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Social anxiety disorder, also called social phobia, is characterized by an intense anxiety or fear in social situations. The individual fears being judged, negatively evaluated, or rejected. People with social anxiety disorder may worry about acting or appearing visibly anxious (e.g., shacking, blushing, stumbling over words), or being viewed as stupid, awkward, or boring. These situations are avoided or endured with extreme discomfort. Treatment is based on medication (most commonly antidepressants) or psychotherapy. There is no consensus if combining medication and psychotherapy would result in additional improvement. The aim of this study is to investigate exactly that, specifically if combining a specific antidepressant (sertraline) and two different kinds of psychotherapy (psychodynamic (PDT) or cognitive-behavioural therapy (CBT)) would work better.

Who can participate?
Individuals aged 18 to 65 with social anxiety disorder

What does the study involve?
Participants are randomly allocated to receive either PDT or CBT. The same patients are also randomly allocated to receive either sertraline or placebo (dummy drig), resulting in four different treatment combinations: sertraline + PDT; sertraline + CBT; placebo + PDT; and placebo + CBT. The treatment lasts 20 weeks. Participants are assessed before treatment and at weeks, 1, 4, 8, 12, 16 and 20.

What are the possible benefits and risks of participating?
Participants have a chance to receive either treatment with medication called sertraline or psychological therapy with a specialised therapist or treatment with a combination of both, which may help to treat their social anxiety disorder. The information from this study will help to show whether combining sertraline and psychotherapy is better than psychotherapy alone and which kind of psychotherapy is better for combining with medication. Participants are asked about how they are feeling when they complete the questionnaires and this may be a bit upsetting for them. The treatment may cause some distress and anxiety but has been shown to be very effective. Sertraline could be related to some side effects (like nausea, sexual dysfunction and insomnia) that are generally well tolerated.

Where is the study run from?
Sao Paulo University Medical School (Brazil)

When is the study starting and how long is it expected to run for?
March 1996 to November 2016

Who is funding the study?
Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP; Brazil)

Who is the main contact?
Dr Marcio Bernik
marcio.bernik@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marcio Bernik

ORCID ID

http://orcid.org/0000-0001-7922-6747

Contact details

Ambulatório de Ansiedade
Instituto de Psiquiatria
Hospital das Clínicas da FMUSP. R. Dr. Ovídio Pires de Campos
785 CEP: 05403.010 – Caixa Postal 3671
São Paulo
-
Brazil
+ 55 (0)11 26616988
marcio.bernik@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1997/11285-1

Study information

Scientific title

In social anxiety disorder, does concomitant treatment with sertraline and psychotherapy improve social skills acquisition? A double-blind, double dummy randomized controlled trial

Acronym

Study hypothesis

1. Combining pharmacotherapy with an SSRI and psychotherapy would be superior to psychotherapy alone in the treatment of SAD patients
2. Group cognitive-behavioural therapy (GCBT) would be superior to group psychodynamic therapy (GPT)
3. Group cognitive-behavioural therapy and group psychodynamic therapy are different regarding possible additive or synergistic effects with a selective serotonin reuptake inhibitor

Ethics approval

The hospital ethics committee (CEAPESQ), 12/03/1997, ref: 021/97

Study design

Single-centre double-blind double-dummy randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Social anxiety disorder

Intervention

Participants were assessed prior to treatment (week -2) for diagnostic confirmation, consent form completion, assessment of inclusion and exclusion criteria. Potential participants were selected and randomly assigned to one of the four treatment groups using a 1:1:1:1 randomization schedule (using a programed Excel Microsoft Office spreadsheet). A research assistant not involved in other steps of the study performed the procedure. The four treatment conditions were:
1. Sertraline + group cognitive-behavioral therapy (Ser-GCBT)
2. Sertraline + group psychodynamic therapy (Ser-GPT)
3. Placebo + GCBT (Pla-GCBT)
4. Placebo + group psychodynamic therapy (Pla-GPT)

Therapists provided treatment in GCBT and GPT following a standardized treatment manual for GCBT and psychodynamic instructions for GPT. GCBT involved twenty 90-minute sessions. Subjects assigned to GCBT received training in anxiety-management skills and social skills followed by behavioral exposure to anxiety-provoking situations. GPT involved twenty 90-minute sessions of psychodinamic psychotherapy without training in anxiety-management skills, social skills or behavioral exposure. All therapy sessions were recorded and 30% were randomly selected and analyzed by independent raters for adherence to the treatment manual. All therapists providing GCBT were experienced behavior therapists and therapists providing GPT were also experienced therapists of mostly psychodynamic background.

Follow up medical/pharmacotherapy consultations involved eight sessions of 45 minutes each that included review and ratings of the severity of subjects’ anxiety, their response to treatment, and adverse events. Sertraline or pill placebo were administered on a fixed-flexible schedule beginning with 50 mg per day for sertraline and adjusted up to 200 mg per day. At week 4 and later, those subjects considered mildly ill or worse and with minimal side effects were eligible for dose increments.

Treatment lasted 20 weeks and patients were re-evaluated at weeks, 1, 4, 8, 12, 16 and 20. Efficacy measures were applied in every visit.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

1. Treatment global clinical response, measured as a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale at week 20
2. Core social symptoms measured using the Scale of Avoidance and Social Discomfort (SASD) at week 20
3. Social skills acquisition, time-by-treatment interaction of the SASD score (week 0 vs week 20) and Multidimensional Scale of Social Expression – Motor Part (M-MSSE) score (week 0 vs week 20)

Secondary outcome measures

1. Final social skills measured using final score in M-MSSE at week 20
2. Final social anxiety symptoms measured using final score in SASD at week 20
3. Social anxiety symptoms measured using Fear of Negative Evaluation (FNE) final score at week 20 and time-by-treatment interaction
4. Global symptoms measured using Clinical Global Impression - severity (CGI–S) final score at week 20 and time-by-treatment interaction
5. Improvement in global symptoms measured using Clinical Global Impression – Improvement (CGI–I) final score at week 20
6. Anxiety symptoms measured using Hamilton Anxiety Rating Scale (HAM-A) final score at week 20 and time-by-treatment interaction
7. Depressive symptoms measured using Hamilton Depression Rating Scale (HAM-D) final score at week 20 and time-by-treatment interaction
8. Depressive symptoms as measured using Beck Depression Inventory (BDI) final score at week 20 and time-by-treatment interaction
9. Safety assessed using the SAFTEE questionnaire at the basal visit and at every visit thereafter

Overall trial start date

12/03/1996

Overall trial end date

30/11/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Recruitment occurred at the Anxiety Disorders Program of the Institute of Psychiatry, Sao Paulo University Medical School
2. Participants aged from 18 to 65 years were interviewed first by a clinical psychologists using a protocol specific interview and then by a psychiatrist using the Structured Clinical Interview for DSM-IV
3. Social anxiety disorder had to be the primary diagnosis, with or without comorbid depression
4. Symptom duration had to exceed 1 year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

146

Participant exclusion criteria

1. Clinically significant suicidal risk
2. Beck Depression Inventory score greater than or equal to 30
3. Hamilton Depression Rating Scale score greater than or equal to 21
4. Any other primary psychiatric DSM-IV diagnosis
5. Any medical-systemic disease possibly affecting mental condition including epilepsy
6. Intake of more than two units of alcohol/day
7. Current use of antidepressant medications or benzodiazepines

Recruitment start date

01/05/1999

Recruitment end date

31/01/2013

Locations

Countries of recruitment

Brazil

Trial participating centre

Ambulatório de Ansiedade, Instituto de Psiquiatria, Hospital das Clínicas da FMUSP
R. Dr. Ovídio Pires de Campos, 785
São Paulo
05403-010
Brazil

Sponsor information

Organisation

FAPESP - Fundação de Amparo à Pesquisa do Estado de São Paulo

Sponsor details

R. Pio XI
1500
São Paulo
05468-901
Brazil
+55 (0)11 3838 4000
fapesp@fapesp.br

Sponsor type

Research organisation

Website

www.fapesp.br

Funders

Funder type

Research council

Funder name

FAPESP - Fundação de Amparo à Pesquisa do Estado de São Paulo (Research Support Foundation of São Paulo State)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The manuscript is ready for submission and the trialists will seek publication in a high impact journal. They think the results may help change prejudice against adding medication to patients treated with psychotherapy in social phobia. They plan to publish it this year (2018).

IPD sharing statement
Since the dataset is small, individual data may be uploaded as supporting information files accompanying the manuscript. Individual scores of all outcome measures in every visit should then be available as a spreadsheet file. Data on age and gender may also be available, but any information that could be used to identify individual subjects will not. In other words, data will be anonymized to protect patients privacy. In this case, the journal site will serve as public repository not requiring previous request for consultation, just requiring registering in the site. Data will be available as soon as the manuscript is published and will be available indefinitely. Participants gave consent to the use and publication of anonymised data.

Intention to publish date

31/12/2018

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes