Tuesday, April 24, 2007

Social Anxiety Research Protocol

Entry for 24 April 2007

The research protocol for the Person-Centred/Experiential Therapy for Social Anxiety study has been completed. I turned it in to the EPS Department Ethics Committee on Friday, hoping that they would not sit on it too long before they forwarded it on to University Ethics Committee. Unfortunately, they sent it on through regular campus mail, so it missed the deadline by a day and may have to wait until June to be reviewed.

The Social Anxiety Study Group has been discussing the research protocol for months, and I’ve spent the past 3 weeks working steadily on it. The final document has 20 appendices, mostly questionnaires and interview schedules. It took all last week just to finalize and print them off, and we are continuing to tinker with various ones.

In the process, we have devised a various new or revised instruments, and of course gotten much clearer on what we actually going to be doing. We are now hoping to begin recruiting clients in early May, assuming the ethics review doesn’t get put off until June, and that they actually approve it on the first go.

One thing we’ve tackled as part of the ethics proposal is who is going to be in the study and who is not. This requires specification of inclusion and exclusion criteria:

Inclusion criteria: (1) Person sees self as having social anxiety difficulties; (2) meets criteria for DSM-IV diagnosis of social anxiety disorder; (3) willingness to take part in research procedures (interviews, questionnaires, video/audio recording)

Exclusion criteria: (1) Currently in psychotherapy or counselling elsewhere; (2) current severe substance abuse; (3) current active psychotic condition; (4) current domestic violence situation; or (5) other current clinically predominant disorder/problem (e.g., social anxiety secondary to medical condition or depression)

Here is the research protocol as it stands:

A. Initial Contact:
1. Recruitment: Website; flyer; targeted announcements
2. Initial Contact: email; or research clinic number (office or researcher)
3. Telephone Screening: 20-30 minute pre-screening form by researcher or team member/diploma student

B. Screening:
4. Face-to-face Screening/ Intake: 2-4 hrs diagnostic assessment:
4a. Diagnostic: Clinical Disorders: Anxiety Disorder Interview Schedule (ADIS-IV)
4b. Diagnostic: Disordered Personality Processes: Personality Diagnostic Questionnaire-version 4 (PDQ-4)
4c. General consent form: Given & completed
4d. Individualized change measure: Personal Questionnaire: worksheet, followed by interview to construct
4e. Consent to use recordings: Completed (review later)
5. Assignment to counseling/ counselor: To either classical person-centred or process-experiential/emotion-focused therapy (?random)

C. Therapy Outcome:
6. Outcome measures: Pre; midtreatment: after session 8; postherapy; 6- & 18-mo follow-ups
6a. General problem distress: CORE-Outcome Measure
6b. Individualized problem distress: Personal Questionnaire (weekly; 2 pretests)
6c. Problem specific: Social Phobia Inventory (2 pretests)
6d. Theory-specific:
(i) Experiential access: Strathclyde Inventory
(ii) Self-Concept: Self-Relationship Questionnaire
6e. Interpersonal: Inventory of Interpersonal Problems
6f. Health/Cost offset: Health Utilization Scale

D. Session-Level Processes:
7. Client Post-session:
7a. Qualitative events: Helpful Aspects of therapy (HAT) Form
7b. Therapeutic relationship: Working Alliance Inventory-12-R
7c. Theory-specific: Therapeutic Relationship Scale (being developed)
8. Therapist Post-session: Theory-specific:
(i) PE-EFT: Therapist Experiential Session Form-2
(ii) PCA: Therapist version of Therapeutic Relationship Scale

E. Mid/Post Only:
9. Mid/post-therapy: After session 8; post; follow-ups; administered by researcher or team member
(i) Change Interview: Changes; helpful/ unhelpful aspects
(ii) Relational Depth Scale
(iii) Consent to release recordings: Review

With many thanks to the members of the Social Anxiety Study Group for their help in developing the protocol!

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