Evaluation of an online cognitive-behavioural treatment programme for social anxiety for higher education students: the Participate programme.

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN12505737
• Date of registration: 03/12/2015
• Prospective Registration: No
• Primary sponsor: National University of Ireland, Galway
• Public title: Evaluation of an online cognitive-behavioural treatment programme for social anxiety for higher education students: the Participate programme.
• Scientific title: A randomised controlled trial of the effectiveness of the Participate online cognitive-behavioural treatment programme for social anxiety for higher education students whose social anxiety scores exceed cut-off points on the SIAS-6/SPS-6 social anxiety scales, comparing changes in social anxiety score at programme end and 3-month follow-up for participants with weekly online support; those without weekly online support; and those on a waiting-list.
• Date of first enrolment: 01/09/2014
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12505737
• Study type: Interventional
• Study design: Multi-centre, interventional randomised controlled trial (Treatment)

Countries of recruitment

Ireland, United Kingdom

Contacts

• Name: Éamonn Ó Dochartaigh

Key inclusion & exclusion criteria

Inclusion criteria: 1. Participants must be registered students of the relevant higher-education institution
2. Participants must have a score 6 or more on the SIAS-6 questionnaire or 3 or more on the SPS-6 psychometric scales
Exclusion criteria: Participants must not:
1. be acutely suicidal
2. begin or change a dose of psychoactive medication in the period from 1 month preceding the programme until its end
3. be receiving psychotherapeutic treatment in the period from 1 month preceding the programme until its end
4. have a history of bipolar depression
5. have previously received cognitive-behavioural therapy

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Social anxiety.
Mental and Behavioural Disorders

Intervention(s)

There are 3 arms to the trial:
1. Group 1 will undertake an online cognitive-behavioural programme for social anxiety with weekly support via email
2. Group 2 will undertake the same programme but without weekly support
3. Group 3 will be tested before and after the programme period without treatment, since they are on a waiting-list for the programme

Primary Outcome(s)

Primary outcome measures are to assess the severity of social anxiety. They consist of:
1. The 6-question short form of the Social Interaction Anxiety Scale (SIAS-6)
2. The 6-question short form of the Social Phobia Scale (SPS-6)

They are measured at completion of an introductory module; after 8 weeks (at programme end); and 3 months later in a follow-up.

Secondary Outcome(s)

1. Social anxiety, consisting of the short form of the Social Phobia Inventory (miniSPIN), and administered at weekly intervals during the 8-week programme
2. Severity of depression and suicidal ideation, consisting of the 9-question form of the Patient Health Questionnaire (PHQ-9) and administered at the end of an introductory module; after 8 weeks (at programme end); and 3 months later in a follow-up
3. Self-reported social, academic and occupational functioning, consisting of some purpose-designed questions, which are administered at weekly intervals during the 8-week programme, at programme end, and 3 months later in a follow-up

Secondary ID(s)

Participate_v2_supported_vs_unsupported

Source(s) of Monetary Support

Student Project Fund, National University of Ireland, Galway