Entry for 18 October 2007:
The NRES (NHS Research Ethics Service) application asks for a research proposal, including theoretical formulation, which is nice to have as a summary:
Purpose and significance: The main purpose of this research is to validate and improve under-researched Person-Centred/Experiential psychotherapy (PCEP) approaches to Social Anxiety, thus increasing the range of effective treatments that can be offered to these clients. The approaches to be studied are Person-Centred Therapy (also known as nondirective counselling), currently used extensively in NHS primary care settings, and a newer, enhanced version of this therapy, known as Process-Experiential or Emotion-Focused Therapy. Although extensive evidence supports the use of these therapies for depression, neither has previously been studied as a treatment for Social Anxiety, a widespread psychiatric disorder with links to key social problems such as substance misuse and employment difficulties.
Theory of etiology: From the point of view of PCEPs, social anxiety is understood as a result of early experiences of social trauma stemming from shaming by family, other adults, and peers. As a result of these experiences the person develops: (a) a sense of self as incompetent and unacceptable; (b) an understanding of others as setting severe demands that can never be met (“conditions of worth”); and, as a consequence, (c) a strong inner “critic” that continually induces shame in the self; and (d) a emotional avoidance and constriction.
Theory of change: PCEPs address these four sources of social anxiety by (1) offering an empathic, caring, and genuine relationship, which (2) counters the client’s expectations of severe external judgment; this in turn (3) allows the person to begin to discover a sense of self-competence and self-affirmation, which (4) enables them to access and make use of the their full range of emotions. This then provides them with a basis both (5) to counter their inner critic and (6) to initiate assertive action with others in order to meet their needs more effectively.
Recruitment and screening: Clients with symptoms of Social Anxiety will be recruited via University and mental health service user and related websites; by newspaper announcements; by posters and flyers posted in libraries, supermarkets and GP surgeries. (Target sample: n = 20.) Screening will take place in two stages: (1) 20-30 min telephone pre-screening by researcher or team member/postgraduate student; (2) face-to-face structured diagnostic assessment (2 X 2 hr sessions) for DSM-IV Axis I and II mental health disorders, conducted by trained research staff or postgraduate students.
Therapists: Staff and research associates of the Counselling Unit, with credentials in counselling, psychotherapy or clinical psychology; also, advanced postgraduate students in counselling or counselling psychology.
Research design: A standard treatment development design will be used, appropriate to an initial investigation of a psychosocial treatment. The design is a pre-post one-group design (also known as an open clinical trial), with embedded single case design, continuous outcome assessment, and mixed method (quantitative and qualitative) self-report data collection. There will be two partially-overlapping arms within the group design, for exploring variations in the treatment approach, one a nondirective person-centred approach, the other using an enhanced form of person-centred therapy (Process-experiential/Emotion-Focused therapy). For most analyses, data from the two arms will be combined, with only exploratory comparative analyses being carried out (due to statistical power issues). The design allows assessment of outcome; estimates of causal efficacy (at the single case level using systematic case study methods); psychometric evaluation of quantitative measures; and qualitative research on client perceived outcome, helpful factors and significant events. The mixed method design allows use of methods with complementary strengths and weaknesses, thus reducing overall bias. Systematic case studies will use rigorous debiasing methods in the form of careful search for alternative explanations for apparent client change and possible causal effects of therapy.
What clients will be asked to do: (1) Telephone screening interview (20-30 min). (2) Structured diagnostic interviews (2 X 2 hrs): Structured Clinical Interview for DSM-IV (SCID-IV); Personality Disorders Questionnaire-IV; Social Phobia Inventory; Personal Questionnaire Interview; Informed Consent Form. (3) Attend up to 20 therapy sessions of 50 min each, video- and audio-recorded. (4) Before session 1; after session 8; at end of therapy; and at 6- and 18-month follow-up: Complete quantitative outcome measures (CORE-OM, Personal Questionnaire, Social Phobia Inventory, Strathclyde Inventory, Self-Relationship Questionnaire, Inventory of Interpersonal Problems, Helath Utilization Scale; 90 min). (5) After session 8; at end of therapy; and at 6- and 18-month follow-up: semi-structured qualitative interview (the Change Interview; 60 min); Consent to Release Recordings (after session 8 & end of therapy; 10 min). (6) After session 8; at end of therapy: Relational depth scale (20 min). (7) Before each session: Personal Questionnaire (1 min). (8) After each session: Complete brief self-report questionnaires (Helpful Aspects of Therapy Form, Therapeutic Relationship Scale, Working Alliance Inventory; 20 min). (9) After sessions 3, 5, 8: Relational Depth Scale (10 min). (10) Recordings of therapy sessions (for later qualitative and quantitative analyses).
What therapists will be asked to do: After each session: Complete self-report adherence questionnaires appropriate their approach, including process notes (Person-centred: Therapeutic Relationship Scale; Process-Experiential: Therapist Experiential Session Form – 3) (30 min)
Data Archive: The data collected will form a psychotherapy research archive for use over a period of at least 5 years by research team members at the University of Strathclyde. With clients' separate and additional, the data will be stored securely (in the research base in D303B until the move to the John Anderson Campus and after that in a dedicated secure storage room) under the supervision of the chief researcher or his successor. All written data will be anonymized; video/audiorecordings cannot be totally anonymized but will be stored separately and securely. This is a standard procedure in psychotherapy research.
No comments:
Post a Comment