To investigate the efficacy of testosterone enhanced exposure therapy for social anxiety disorder.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main outcome is reduction of social anxiety disorder symptoms, as assessed
by Subjective Units of Distress (SUDs). participants will provide fear ratings
(ranging from 0; no fear to 100 most anxiety imaginable) prior and during both
exposure sessions.
Secondary outcome
- Subsequently, outcome will be assessed by other self-report questionnaires
(Liebowitz Social Anxiety Scale (LSAS), Social Phobia Scale (SPS), Social
Phobia Anxiety Inventory (SPAI), Beck Depression Inventory (BDI), Visual
Analogue Scales (SUDs) and Harm Expectancy (HE) ratings.
- Video-tapes of participants* performance during each exposure session will be
rated with the Social Performance Rating Scale (SPRS), which is an evaluation
of behavioral indicators of anxiety.
- Both exposure sessions will be audio-recorded and transcribed, speech will be
rated and analyzed by the Linguistic Inquiry and Word count (LIWC).
-In addition, we will assess automatic socio-anxiolytic behavior tendencies by
means of implicit measures, e.g. approach/aviodance and risktaking behaviour.
Background summary
Social anxiety disorder (SAD) is the most common anxiety disorder and among the
most common psychiatric disorders. If untreated, the disorder typically follows
a chronic, unremitting course leading to substantial impairments in vocational
and social functioning. Exposure therapy is a proven effective treatment for
SAD, but remission rates tend to be low, underscoring the need for new
treatment strategies that enhance remission rates. A novel line of research has
shown that pairing exposure therapy with a pharmacological agent, aimed at the
enhancement of underlying mechanisms of action of exposure therapy, augments
treatment effects. Testosterone plays an important role in social motivational
behavior, and administration of a single dose has been shown to diminish social
fear symptoms and avoidance behavior. As exposure therapy is aimed at reduction
of avoidance behavior, we argue that testosterone administration could enhance
this process. In this first efficacy study, we aim to investigate the
augmentation effects testosterone by conducting a randomized placebo-controlled
clinical trial comparing four sessions of exposure therapy plus testosterone
(0.50 mg) with exposure therapy plus placebo. We expect testosterone enhanced
exposure therapy to lead to superior outcome.
Study objective
To investigate the efficacy of testosterone enhanced exposure therapy for
social anxiety disorder.
Study design
The planned study is a double-blind randomized placebo controlled trial.
Intervention
Participants will be randomly allocated to receive exposure therapy plus
testosterone (sublingual, 0.50 mg) or exposure therapy plus identical looking
placebo. Testosterone/Placebo will be administered four hours prior to two 60
minutes exposure sessions, during the first exposure session the participants
will receive testosterone/placebo and during the second session they will
receive exposure therapy without testosterone/placebo.
Study burden and risks
We believe the risk of the current study to be very limited. The possible side
effects of single doses of 0.5 mg testosterone cyclodextrin are negligible.
Tarweweg 2
Nijmegen 6534AM
NL
Tarweweg 2
Nijmegen 6534AM
NL
Listed location countries
Age
Inclusion criteria
- Woman, 18-45 years old
- Social Anxiety Disorder (SAD) as established with a structured interview (MINI), and with speech anxiety as primary fear
- Self reported SAD symptoms above clinical cut-off (score > 30 on the Liebowitz Social Anxiety Scale)
Exclusion criteria
- Prior non response to exposure therapy (i.c. speech exposure) for SAD symptoms, as defined by the patient*s report of receiving specific and regular exposure assignments as part of previous therapy.
- Entry of patients with other mood or anxiety disorders will be permitted in order to
increase accrual of a clinically relevant sample; however in cases where SAD is not judged
to be the predominant disorder, participants will not be eligible.
- Psychosis or delusion disorders (current or in the past)
- Patients with significant suicidal ideations or who have enacted suicidal behaviors within 6
months prior to intake will be excluded from participation and referred for appropriate clinical
intervention.
- Mental retardation
- Substance abuse or alcohol dependence
- Somatic illness
- Women of childbearing potential that are not willing to use an active form of birth-control during the trial
- Pregnancy or lactation
- Infertility
- Antipsychotic medication
- Participants that use antidepressants or benzodiazepines will not be excluded, but have to be on a stable dose for at least 6 weeks prior to enrollment.
- Insufficient ability to speak and write Dutch
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004475-23-NL |
| CCMO | NL47410.091.14 |
| OMON | NL-OMON20251 |