Home » Trials » SLCTR/2015/013
A randomised controlled trial investigating the effectiveness of cognitive behavior group therapy compared to a wait list control in the treatment of university students with social phobia
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SLCTR Registration Number
SLCTR/2015/013
Date of Registration
The date of last modification
Feb 25, 2021
Trial Status
Scientific Title of Trial
A randomised controlled trial investigating the effectiveness of cognitive behavior group therapy compared to a wait list control in the treatment of university students with social phobia
Public Title of Trial
A randomised controlled trial investigating the effectiveness of cognitive behavior group therapy compared to a wait list control in the treatment of university students with social phobia
Disease or Health Condition(s) Studied
Social Phobia
Scientific Acronym
None
Public Acronym
None
Brief title
RCT comparing GCBT Vs wait list control
Universal Trial Number
U1111-1168-9160
Any other number(s) assigned to the trial and issuing authority
P60/05/2013(University of Kelaniya)
What is the research question being addressed?
What is the effectiveness of Group Cognitive Behaviour therapy compared to a wait list control in a group of university students with social phobia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Participants would be seen at a community setting (non-hospital based) at the Faculty of Medicine, University of Kelaniya, and the University of Moratuwa
Participants meeting the inclusion/exclusion criteria will be randomized into two arms using computer generated random numbers.
Arm 1 will receive Cognitive Behavior Group Therapy (GCBT). This will run for 12-weeks and will combine in vivo exposure and cognitive restructuring with sessions by a trained therapist (total of four sessions). Sessions will take place in groups of ten participants. Each session will be specifically structured to include education, role plays and repeated scenarios, and discussion on treatment gains and recommendations for future practice. Between sessions, subjects will complete homework assignments designed to help them confront fearful social situations using the techniques learned in therapy.
The sessions will be videotaped, evaluated and feedback and supervision will be provided to the therapists weekly by a psychiatrist who has had extensive training in psychotherapy.
Arm 2 will be the wait list control arm. Participants will be managed in the standard manner and reviewed for symptoms pattern worsening, etc at one week, 6 weeks and 12 weeks. Sessions will be randomly audio recorded to make sure no CBT is being administered.
All participants will be reviewed by a blinded consultant psychiatrist at one week, six weeks and 12 weeks, especially to see any worsening of symptoms, emergence of depressive symptoms and or suicidal ideas. In such an instance participants will be withdrawn from the trial and offered an alternative treatment.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Level of anxiety symptoms as indexed by scale scores on the LSAS-SR, CGI before and after group Cognitive Behavioural Therapy |
[ At baseline, one week, six weeks, 12 weeks from the commencement of the study. ] |
2.
Salivary cortisol levels before and after group Cognitive Behavioural Therapy |
[ At baseline, one week, six weeks, 12 weeks from the commencement of the study. ] |
Secondary outcome(s)
1.
None |
[ None ] |
Target number/sample size
100 (50 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-08-01
Anticipated end date
2015-10-30
Date of first enrollment
2015-09-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
National Research Council and University of Kelaniya (grant no. 13-115)
Regulatory approvals
Status
Approved
Date of Approval
2013-05-15
Approval number
P60/05/2013
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
Telephone: | +94-11-2961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.Aruni Hapangama
Senior Lecturer
Department of Psychiatry, Faculty of Medicine, University of Kelaniya
Tel: 0777917311
Mob: 0777917311
Fax: 0094112958337
Email: ahapangama@yahoo.co.uk
Contact Person for Public Queries
Dr.Aruni Hapangama
Senior Lecturer
Department of Psychiatry, Faculty of Medicine, University of Kelaniya
Tel: 0777917311
Mob: 0777917311
Fax: 0094112958337
Email: ahapangama@yahoo.co.uk
Primary study sponsor/organization
National Research Council, Sri Lanka
380/97, Bauddhaloka Mawatha
Colombo 07, Sri Lanka
Tel: +94 11 269 5060
Fax: +94 11 267 5136
http://www.nrc.gov.lk/
Secondary study sponsor (If any)
University of Kelaniya, Sri Lanka
Kelaniya 11600,
Sri Lanka.
Tel : +94 112903903
Fax: +94 11 2913857
Email: info@kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results