Evaluating Psychological Interventions Empirically Supported ...


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Evaluating Psychological Interventions Empirically Supported ...

  1. 1. Evaluating Psychological Interventions Empirically Supported Treatments Needles and Shots Example Cognitive-Behavioral Therapy Gregg Selke, Ph.D. PSY 4930 October 31st , 2006
  2. 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. 3. Should we evaluate the effectiveness of psychological interventions? Yes, and here is why!  Estimated >400 forms of psychotherapy 1. Specificity  Matching which interventions are most effective to specific problems 2. Ethical Obligation  Responsibility to clients to use best treatments (supported by research)
  4. 4. Should we evaluate the effectiveness of psychological interventions? 3. Field Advancement  Increases credibility of field  Refines our clinical skills and treatments  Better outcomes & cost efficiency 3. 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. 5. How should we evaluate and measure effectiveness? Rigorous Experimental Methods 1. Random Assignment to treatment groups  Reduces risk of ending up with more severe patients in one group 2. Using appropriate control or comparison group(s) 3. Using valid and reliable outcome measures  E.g., most sensitive test of depression 4. Consistency of therapist(s) across patients  Pre- and Post-treatment evaluation
  6. 6. 1. Within-subjects designs 2. Between-subjects designs 3. Meta-analysis Three suggested methods for measure effectiveness
  7. 7. Within-subjects designs  Individual acts as own control by undergoing each intervention or non- intervention condition  Single-Case & Group Experimental Designs 1) 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. 8. Within-subjects designs Single-Case & Group Experimental Designs 2) 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. 9. Between-subjects designs  Groups of individuals undergo different or no interventions  Increases support for improvement actually being due to treatment 1) 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. 10. Between-subjects designs 2) 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. 11. Between-subjects designs 2) Types of Randomized Clinical Trials a) No-treatment control group (ethical issues) b) Wait-list control group (get treatment later) c) Placebo control group (e.g., double-blind trials)  E.g., nonspecific support in psychology a) Comparing Multiple Interventions  E.g., behavior therapy, meds, behavior therapy+meds, wait-list control, & placebo
  12. 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. 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 1.1. Best Support (“Well-EstablishedBest Support (“Well-Established Treatments”)Treatments”) 2.2. Promising (“Probably EfficaciousPromising (“Probably Efficacious Treatments”)Treatments”)
  14. 14. Criteria for “Well-Established Treatments” or Best Support I. At least two good between group design experiments demonstrating efficacy in one or more of the following ways: a. Superior to pill placebo, psychological placebo, or another treatment. b. Equivalent to an already established treatment in experiments with adequate statistical power (about 30 per group; cf. Kazdin & Bass, 1989).  
  15. 15. Criteria for “Well-Established Treatments” or Best Support OR II. A large series of single case design experiments (n > 9) demonstrating efficacy. These experiments must have: a. Used good experimental designs b. Compared the intervention to another treatment as in I.a. (superior to placebo, etc.)
  16. 16. Criteria for “Well-Established Treatments” or Best Support AND Further criteria for both I and II: III. Experiments must be conducted with treatment manuals. IV. Characteristics of the client samples must be clearly specified. V. Effects must have been demonstrated by at least two different investigators or teams of investigators.
  17. 17. Criteria for “Probably Efficacious Treatments” or Promising I. 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. 18. Criteria for “Probably Efficacious Treatments” or Promising OR II. One between group design experiment with clear specification of group, use of manuals, and demonstrating efficacy by either: a. Superior to pill placebo, psychological placebo, or another treatment. b. Equivalent to an already established treatment in experiments with adequate statistical power (about 30 per group; cf. Kazdin & Bass, 1989).
  19. 19. Criteria for “Probably Efficacious Treatments” or Promising OR III. 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. 20. Example Empirically Supported Treatment Behavioral Distress in Venipuncture and Immunizations
  21. 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. 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. 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. 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. 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. 26. Goals  ↓Distress, ↑ Coping, ↑ Cooperation  Intervene early to prevent future distress  Find Practical, Cost-Effective Methods to Alleviate Distress
  27. 27.  Reviewed Psychlit, Pubmed  Over 20 Intervention Studies  Wide range of treatment populations  Predominant Component: Distraction  Caveat: only reviewed up until 2001 Literature Review
  28. 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. 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 Coaching of Party Blower (Breathing /relaxation) c) Parent Reassurance: trained/encouraged  Outcome: ↓ restraint with Distraction + Coaching  Reassurance 3X restraint & > Verbal Fear than Distraction and Standard
  30. 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,  Party Blower 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. 31. Gonzalez, Routh, Armstrong. Effects of maternal distraction versus 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”
  32. 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. 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. 34. 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 Conclusions
  35. 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. 36. Anxiety Disorders “Well-Established Treatments” “Probably Efficacious Treatments” Specific Phobia 1. Participant Modeling* 2. Reinforced Practice* 1. Cognitive Behavior Therapy 2. Systematic Desensitization* Generalized Anxiety Dx (GAD) None 1. Cognitive Behavior Therapy 2. Modeling* 3. In Vivo Exposure* 4. Relaxation Training* 5. Reinforced Practice* 6. Family Anxiety Management Separation Anxiety None Same 6 treatments as GAD Agoraphobia None None OCD None None Panic Disorder None None PTSD None None Social Phobia None None * These can be considered components of CBT
  37. 37. Depressive Disorders “Well-Established Treatments” “Probably Efficacious Treatments” Major Depressive Disorder 1. Interpersonal Therapy 1. CBT 2. Psychotropic Medications Dysthymic Disorder 1. Interpersonal Therapy 1.CBT 2.Psych Med Adjustment Disorder 1. Interpersonal Therapy 1.CBT 2.Psych Med
  38. 38. ADHD “Well-Established Treatments” “Probably Efficacious Treatments” 1. Stimulant Meds 2. Behavioral Parent Training 3. Behavioral Classroom Interventions 1. Social Skills Training with Generalization Components 2. Summer Treatment Programs
  39. 39. ODD & CD “Well-Established Treatments” “Probably Efficacious Treatments” 1. Parent Training Based on the book Living with Children 2. Videotape Modeling Parent Training For Pre-school Age Children: 1. Parent-Child Interaction Therapy 2. Time-Out Plus Signal Seat Treatment 3. Parent Training Program 4. Delinquency Prevention Program For School Aged Children: 1. Anger Coping Therapy 2. Problem Solving Skills Training For Adolescents: 1. Anger Control Training with Stress Inoculation 2. Assertiveness Training
  40. 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. 41. What is CBT? Therapeutic technique that uses a combination of A. 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.  A. 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. 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. 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. 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. 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. 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. 47. Cognitive Theory  The Cognitive Triad 1. Negative view of themselves (e.g., inadequate) 2. Negative view of the world (e.g., unfair) 3. 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. 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. 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. 50. From Cognitive Theory to Intervention  Ellis’ A-B-C-D-E theory  D-dispute irrational beliefs  E-evaluate effects (reduction of depression, anxiety)
  51. 51. D-dispute irrational beliefs Cognitive Reframing Goal of Cognitive Therapy  Must first increase awareness of types of automatic negative thoughts one has  Then learn to pursue thought until arriving at context or prediction that is contributing to it.  Then replace or reframe cognitive distortions/maladaptive thoughts with more balanced and realistic thoughts and beliefs about oneself, the future, and the world around us.  ↓ negative & ↑ positive feelings and behaviors
  52. 52. Possible Components of CBT or Techniques used as part of CBT  Cognitive Reframing  Relaxation Training 1. Diaphragmatic Breathing 2. Imagery 3. Progressive Muscle Relaxation 4. Iatrogenic Relaxation  Modeling  In vivo exposure  Reinforced practice  Social and Communication skills training  Problem-solving training  Anger-management training
  53. 53. Behavioral Strategies  Generally, behavior therapy emphasizes changing behavior by changing the antecedents or consequences, or learning new behavior-based skills
  54. 54. Behavioral Strategies Relaxation Training  Management of anxiety, pain, anger, stress, emotional reactivity, depression, fatigue, etc. 1. Diaphragmatic Breathing 2. Guided Imagery - visualization 3. Progressive Muscle Relaxation 4. Autogenic Relaxation 5. Biofeedback
  55. 55. Behavioral Strategies In Vivo Exposure  Real-life exposure  Practicing approaching and confronting a feared situation or object (e.g., driving, germs)  Sessions should begin with easy situations and gradually work its way up to scarier and harder situations.  OCD, phobias  Extreme versions: implosive therapy, flooding
  56. 56. Behavioral Strategies Modeling  Involves demonstrating non-fearful behavior in a feared situation and showing the child or adolescent a more appropriate response for dealing with a feared object or event  E.g., social situation, dogs
  57. 57. Behavioral Strategies Participant Modeling  Combines modeling and in vivo exposure 1. Model (e.g. therapist, friend, or peer) demonstrates fearlessness and coping responses when confronting a feared situation or object 2. The model assists the child in practicing approaching and confronting the feared situation or object.   Sessions should begin with easy situations and gradually work its way up to scarier and harder situations.
  58. 58. Behavioral Strategies Reinforced Practice  Combines in vivo exposure with a feared situation or object and rewards (e.g. praise, tokens, toys, hugs, etc.) for approaching and confronting a feared situation or object.   Child is rewarded for practicing approaching and confronting a feared situation or object. 
  59. 59. Behavioral Strategies  Contingency management  Changing behavior by controlling it’s consequences  PCIT  Shaping  Reinforcing successive approximations of a behavior  e.g. sitting on toilet for toilet training  Token economy programs
  60. 60. Behavioral Strategies Aversive Conditioning  Reducing unwanted behaviors by pairing it with a negative stimulus  Electric shock  Unpleasant tasting liquid  In children, usually only used with self- injurious behavior  Usually used as a last resort
  61. 61. Behavioral/Cognitive Strategies Systematic Desensitization  Child or adolescent imagines feared object or situation while he/she is engaged in a response that is incompatible with anxiety (e.g. relaxation or play).   Based on the theory of reciprocal inhibition— one cannot be anxious and relaxed at the same time (Wolpe, 1958)  Unlike participant modeling and reinforced practice, the feared object or situation is presented in imagination rather than real life.
  62. 62. Behavioral/Cognitive Strategies Anger Coping Therapy  Designed to address deficiencies in thinking and problem-solving exhibited by aggressive children  Children learn to  Establish group rules and generate reinforcers  Use self-statements to inhibit impulsive behaviors  Identify problems and take other perspectives  Generate alternate solutions and be aware of consequences of their actions  Model videotapes and become more aware of physical symptoms involved in anger  Make their own video of problem-solving and self-inhibiting statements  Role-playing to solve current anger problems
  63. 63. Behavioral/Cognitive Strategies Problem Solving Skills Training  Teaches children skills to solve problems better   Developing alternative solutions, anticipating consequences, and taking others’ perspectives  Parents taught to manage their children’s behavior using time-out, positive reinforcement, negotiating, and other strategies.   Teaching methods included role-playing, corrective feedback, practice, modeling, and token economy. 
  64. 64. Behavioral/Cognitive Strategies  Social Skills Training  Used with patients with depression, anxiety, social phobia, schizophrenia  Focuses on verbal and nonverbal behaviors  Uses behavioral techniques such as modeling, role play, rehearsal  Patient begins to be positively reinforced for social skills
  65. 65. Behavioral/Cognitive Strategies  Social Skills Training may focus on:  Maintaining eye contact  Smiling at appropriate times  Matching tone of voice to content  Accurately perceiving the emotions of others  Interpreting nonverbal behaviors  Making requests of others  Standing up for their rights  Maintaining a conversation  Timing responses appropriately
  66. 66. Progressive Muscle Relaxation In-Class Exercise  Systematic tensing and relaxation of major muscle groups of whole body  With practice, goal is to learn to become deeply relaxed fairly rapidly  Impossible to be tense and relaxed at same time, can implement skill when noticing that you are starting to become tense and anxious