Evaluating Psychological Interventions Empirically Supported Treatments Needles and Shots Example Cognitive-Behavioral

1. Evaluating Psychological InterventionsEmpirically Supported Treatments Needles and Shots Example Cognitive-Behavioral Therapy Gregg Selke, Ph.D. PSY 4930 October 31st, 2006

2. Should we evaluate the effectiveness of psychological interventions? • Criticisms • Patients are too heterogeneous to be evaluated statistically • Psychotherapeutic interventions are too individualized to be evaluated empirically • Issues and desired outcome is different for every patient • Difficult to define, quantify, and measure “process” of therapy (e.g., rapport, empathy, transference) • Fear that “lists” of “effective” treatments will be used by managed care to determine what will and will not be paid for.

3. Should we evaluate the effectiveness of psychological interventions? Yes, and here is why! • Estimated >400 forms of psychotherapy • Specificity • Matching which interventions are most effective to specific problems • Ethical Obligation • Responsibility to clients to use best treatments (supported by research)

4. Should we evaluate the effectiveness of psychological interventions? • Field Advancement • Increases credibility of field • Refines our clinical skills and treatments • Better outcomes & cost efficiency • Support for Theory behind Intervention • Evaluates validity of theoretical basis of an intervention under evaluation • (e.g., Cognitive Therapy: depression is due to underlying negative thoughts and beliefs, so if person becomes less depressed after changing negative thought patterns, theory supported)

5. How should we evaluate and measure effectiveness? Rigorous Experimental Methods • Random Assignment to treatment groups • Reduces risk of ending up with more severe patients in one group • Using appropriate control or comparison group(s) • Using valid and reliable outcome measures • E.g., most sensitive test of depression • Consistency of therapist(s) across patients • Pre- and Post-treatment evaluation

6. Three suggested methods for measure effectiveness • Within-subjects designs • Between-subjects designs • Meta-analysis

7. Within-subjects designs • Individual acts as own control by undergoing each intervention or non-intervention condition • Single-Case & Group Experimental Designs • A-B-A-B design (A=no treatment; B=treatment) • Ethics of withdrawing treatment (enuresis vs. depression) • Not possible to withdraw some treatments (Cognitive Therapy)

8. Within-subjects designs Single-Case & Group Experimental Designs • Multiple Baseline Design • Does not require withdrawal or reversal of intervention • Stepwise introduction of components of treatment (A  B  C) • E.G., hypothetical treatment for ODD • Component A reduce verbal abuse • Component B reduce noncompliance • Component C reduce aggression • Can not definitively rule out improvements just due to passage of time

9. Between-subjects designs • Groups of individuals undergo different or no interventions • Increases support for improvement actually being due to treatment • Nonrandomized Control Group Studies • 2 “naturally occurring” groups are compared • E.g., ADHD: behavior therapy vs. meds • Poor design! No way of knowing if groups differed (in severity, SES) before interventions

10. Between-subjects designs • Randomized Clinical Trials • Subjects are randomly assigned to different conditions/interventions •  likelihood groups will not differ systematically, or differences will occur more equally across groups

11. Between-subjects designs • Types of Randomized Clinical Trials • No-treatment control group (ethical issues) • Wait-list control group (get treatment later) • Placebo control group (e.g., double-blind trials) • E.g., nonspecific support in psychology • Comparing Multiple Interventions • E.g., behavior therapy, meds, behavior therapy+meds, wait-list control, & placebo

12. Meta-Analysis • “Studies of studies” • Statistical procedure to combine the findings of multiple studies • Uses the effect sizes (how big the average change due to treatment was), and gives more weight to studies with larger samples • Advantage: Studies do not have to use the same measures

13. How do we determine if a treatment is good enough (i.e., valid)? • APA Division 12 and 53 • Guidelines for identifying and promoting empirically “validated” or supported treatments in psychology. • Defining Interventions as • Best Support (“Well-Established Treatments”) • Promising (“Probably Efficacious Treatments”)

14. Criteria for “Well-Established Treatments” or Best Support • At least two good between group design experiments demonstrating efficacy in one or more of the following ways: • Superior to pill placebo, psychological placebo, or another treatment. • Equivalent to an already established treatment in experiments with adequate statistical power (about 30 per group; cf. Kazdin & Bass, 1989).

15. Criteria for “Well-Established Treatments” or Best Support OR • A large series of single case design experiments (n > 9) demonstrating efficacy. These experiments must have: • Used good experimental designs • Compared the intervention to another treatment as in I.a. (superior to placebo, etc.)

16. Criteria for “Well-Established Treatments” or Best Support AND Further criteria for both I and II: • Experiments must be conducted with treatment manuals. • Characteristics of the client samples must be clearly specified. • Effects must have been demonstrated by at least two different investigators or teams of investigators.

17. Criteria for “Probably Efficacious Treatments” or Promising • Two experiments showing the treatment is (statistically significantly) superior to a waiting-list control group.  • Manuals, specification of sample, and independent investigators are not required.

18. Criteria for “Probably Efficacious Treatments” or Promising OR • One between group design experiment with clear specification of group, use of manuals, and demonstrating efficacy by either: • Superior to pill placebo, psychological placebo, or another treatment. • Equivalent to an already established treatment in experiments with adequate statistical power (about 30 per group; cf. Kazdin & Bass, 1989).

19. Criteria for “Probably Efficacious Treatments” or Promising OR • A small series of single case design experiments (n > 3) with clear specification of group, use of manuals, good experimental designs, and compared the intervention to pill or psychological placebo or to another treatment.

20. Example Empirically Supported Treatment Behavioral Distress in Venipuncture and Immunizations

21. Background • Venous blood sampling and immunizations are potentially very painful and frightening to children (and adults). • Prevalence of Needle Phobics estimated to be 4.9% -9% (14/100 in 20 year olds). • Nearly all Children in the U.S. are required to receive immunization shots prior to preschool, and have venipuncture at routine doctor visits.

22. Fear of needles is a primary reason why people are reluctant to donate blood. • Adult fear and avoidance of medical care is associated with having had more medical pain and fear in childhood.

23. Young children (Cohen, 1997) • Rarely show spontaneous overt coping behavior • Have difficulty ignoring aversive stimuli • Do not initiate internal coping strategies (i.e., imagery) as easily as older children and adults

24. Interventions to reduce associated distress are not routinely used in standard care. • Research not well disseminated • Intervention seen as unnecessary for brief procedures • Costs of training and equipment

25. What is Distress? Indicators of Child Distress • Crying, Screaming, Fussing/Whining, Verbal Resistance, Verbal Pain, Verbal Emotion, Request for Emotional Support, Verbal Fear, Information Seeking , Physical Resistance/Flailing, Kicking, Muscular Rigidity • May increase procedure duration, the experience of pain, potential for accidental injury

26. Goals • Distress,  Coping,  Cooperation • Intervene early to prevent future distress • Find Practical, Cost-Effective Methods to Alleviate Distress

27. Literature Review • Reviewed Psychlit, Pubmed • Over 20 Intervention Studies • Wide range of treatment populations • Predominant Component: Distraction • Caveat: only reviewed up until 2001

28. Different Types of Distraction • Party Blower • Cartoon Movie • Kaleidoscope • Lullabies • Parental Non-Procedural Talk • Other Interventions • Picture Book • Behavioral Education to Parents • Different Ways to Implement • Parent Training • Nurse Training • Child Training

29. Manimala, Blount, Cohen. Effects of parental reassurance vs. • distraction on child distress and coping during immunization. • Children’s Health Care (2000) • Subjects: Healthy, N=27-28 per group, preschool immunizations, 3-5 years, clearly identified • Design: Between Group: 3 groups • Interventions • a) Standard • b) Prior to Procedure: Distraction with toys, • puzzles, coloring books, non-procedural talk • During Procedure: Parent Coachingof Party Blower (Breathing /relaxation) • c) Parent Reassurance: trained/encouraged • Outcome:  restraint with Distraction + Coaching • Reassurance 3X restraint & > Verbal Fear than Distraction and Standard

30. Bowen, Dammeyer. Reducing Children’s Immunization Distress • in a primary care setting. J Ped Nursing (1999) • Subjects: Healthy, N=80 (21, 29,30 per group), • 3-6 years, clearly identified • Design: Between Group: 3 groups • Groups/Intervention (no coaching or training) • a) Standard • b) Party Blower (Deep Breathing Distraction) • c) Looking at or blowing a Pinwheel taped down • Outcome:  Distress with Blower compared to standard or pinwheel, • PartyBlower thought to be more distracting than pinwheel b/c more sensory systems are involved. • Based on 2 studies, Party Blower Procedure may meet criteria for “Well-Established”

31. Gonzalez, Routh, Armstrong. Effects of maternal distractionversus reassurance on children’s reactions to injections. • JPP (1993) • Subjects: Healthy, N=42 (14/group), primary care • Ages: 3-7 years, clearly specified • Design: B-G, 3 Groups • Groups/Intervention • a) Minimal Treatment Control • b) Parental Reassurance • c) Maternal Non-Procedural Talk (Distraction) • Outcome: Distraction Associated with  Distress &  Crying, compared to Reassurance & Control • “Promising” Inadequate sample size per group

32. Cohen, Blount, Panopoulos. Nurse coaching and cartoon distraction: an effective and practical intervention to reduce child, parent and nurse distress during immunization. JPP (1997) • Subjects: Healthy, N=92 (about 30/group) • Ages: 4-6, clearly identified • Design: B-G, protocol used • Groups/Intervention • a) Standard • b) Nurse Coach: coach to watch cartoon movie • c) Nurse + Parent/Child Intervention: • - modeling and role playing prior • - nurse + parent coaching during movie • Outcome: both interventions • Distress,  restraint,  coping

33. Cohen, Blount, Cohen, Schaen, Zaff. Comparative study of distraction vs. topical anaesthesia for pediatric pain management during immunization. Health Psych (1999) • Subjects: Healthy, N=39, at school health clinic • 8-11 years, low SES, clearly identified • Design: 3 conditions, Within Subjects, 3 Hep shots • Groups/Intervention • a) Standard • b) Distraction + Nurse Coach: cartoon movie • c) EMLA: lidocane + prilocane applied 1hr prior • Outcome: • Distress,  coping: cartoon + coaching Children coped better with standard than EMLA • Coaching to watch cartoon “Promising” b/c lack of multiple research teams/authors

34. Conclusions Behaviors Associated with High Levels of Distress: Cohen,1997 • Reassurance, too much empathy, apologies, criticism, giving child control over start of the procedure, parental anxiety. Reducing Distress • Distraction, Straightforward Information, Parent and Nursing Coaching, Teaching coping strategies

35. How many empirically supported treatments do you think there are for children and adolescents who have psychological/psychiatric disorders? 100s of estimated forms of psychotherapy

36. * These can be considered components of CBT

40. Cognitive Behavioral Therapy “Probably Efficacious Treatment” • Specific Phobia • Generalized Anxiety Disorder (GAD) • Separation Anxiety • Major Depressive Disorder • Dysthymic Disorder • Adjustment Disorder While not meet EST criteria, also often used for • Agoraphobia, OCD, Panic Disorder, PTSD, Social Phobia

41. What is CBT? Therapeutic technique that uses a combination of • Cognitive Strategies • Alter, manipulate, and restructure distorted and unhealthy thoughts, images, and beliefs. • Assumes that unhealthy thoughts lead to maladaptive behavior, and positive changes in thinking will produce positive changes in emotions and behavior.  • Behavioral Strategies • CBT procedures link cognitive strategies with behavioral strategies • Assumes that by making direct positive changes in behavior, will result in positive changes in thoughts and emotions (e.g., anxiety, depression)

42. Early Foundations of CBT(behavioral aspects) Developed out of Learning Theories • Classical conditioning (Pavlov, Watson): • Focuses on the antecedent of behavior or what occurred before behavior (possible cause) • Learning occurs through association • Conditioning that pairs a previously neutral stimulus with a stimulus that evokes a reflexive response; the stimulus that evokes the response is given whether or not the conditioned response occurs until eventually the neutral stimulus comes to evoke the response • e.g., Pavlovian dogs, Little Albert • Particularly relevant for phobias, PTSD, panic disorder

43. Early Foundations of CBT(behavioral aspects) Learning Theories • Operant Conditioning (Skinner, Thorndike) • Focuses on the consequences of behavior • A process of behavior modification in which the likelihood of a specific behavior is increased or decreased through positive or negative reinforcement each time the behavior is exhibited, so that the subject comes to associate the pleasure or displeasure of the reinforcement with the behavior. • Positive consequences or removal of negative stimuli increase the likelihood of behavior happening again • Negative consequences decrease the likelihood of a future occurrence • E.g., time out for aggression, ending time out for sitting quietly in time out, getting a sticker for using manners

44. Early Foundations of CBT(behavioral aspects) • Social Learning Theory (Bandura): • Focuses on modeling • Learning occurs through modeling or vicarious learning • No direct reinforcement is necessary • E.g., Bobo doll experiments; witnessing violence in media or community or family

45. Early Foundations of CBT(cognitive aspects) Beck (1960s-1970s) • Individuals are affected by objective world AND their subjective perceptions and interpretations • Negative perceptions of events is more likely to lead to depression or anxiety • Even though cognitions or thoughts cannot be directly observed (like behaviors), they can be changed

46. Cognitive Theories • Beck developed cognitive therapy after noticing that depressed patients had cognitions regarding: • Loss • Failure • Abandonment • Rejection • Negative thoughts play a role in the onset and maintenance of depression

47. Cognitive Theory • The Cognitive Triad • Negative view of themselves (e.g., inadequate) • Negative view of the world (e.g., unfair) • Negative view of the future (e.g., I will always fail) • Negative Schemas • Cognitive Distortions/Maladaptive Thoughts • Ways of thinking that lead individuals to perceive and interpret experiences in a negative manner • Automatic: often occur very rapidly in certain situations and may be outside of person’s awareness • Involve discrete predictions or interpretations of a given situation • Develop out of negative experiences

48. Cognitive Theory • Ellis’s A-B-C theory • A-activating events • B-irrational beliefs • C-emotional consequences • When A occurs, an individual automatically engages in negative beliefs/thoughts about the event • E.g., walk by “friend”, you say hi, they do not respond……

49. Cognitive Theory • Examples of irrational beliefs: • When things do not go the way I would like, life is awful, terrible, horrible, or catastrophic • Unhappiness is caused by uncontrollable external events • I must have sincere love and approval from all significant people in my life

50. From Cognitive Theory to Intervention • Ellis’ A-B-C-D-E theory • D-dispute irrational beliefs • E-evaluate effects (reduction of depression, anxiety)