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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

13 Jul 2015

The date of last modification

Feb 25, 2021


Trial Status



Application Summary


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)


Trial Details


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

  1. Consenting males and females above 18 years of age
  2. Current registration as an undergraduate student of University of Kelaniya or the University of Moratuwa
  3. Score of 6 or more in the Mini-Social Phobia Inventory(Mini-SPIN), then confirmed by the Liebowitz Social Anxiety Scale- Self Rated version (LSAS -SR, a score of 55 or more) and the social phobia criteria of the Mini-International Neuropsychiatric Interview (M.I.N.I.)
  4. Score of less than 70 on the Zung Depression rating scale and score less than 3 suicidal ideas (on item 19) of the Zung depression rating scale

Exclusion criteria

  1. Currently undegoing CBT with psychologist or another healthcare professional
  2. Currently on a medication for social phobia (selective Serotonine Reuptake Inhibitor/Tricyclic antidepressant/ Benzodiazepines)
  3. At risk of self-harm or suicide
  4. Current or past diagnosis of psychosis, schizophrenia or bipolar disorder
  5. Primary diagnosis of major depressive disorder, panic disorder, obsessive compulsive disorder, post-traumatic stress disorder or substance dependence
  6. Planning to become pregnant or if pregnant or breastfeeding


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



State of Ethics Review Approval


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 & Sponsor Information


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

Trial Completion details


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