Evaluating Psychological Interventions
Empirically Supported Treatments Needles and Shots Example Cognitive-Behavioral Therapy
Gregg Selke, Ph.D.PSY 4930
October 31st, 2006
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.
Should we evaluate the effectiveness of psychological
interventions?
Yes, and here is why! Estimated >400 forms of
psychotherapy1. Specificity
Matching which interventions are most effective to specific problems
2. Ethical Obligation Responsibility to clients to use best
treatments (supported by research)
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
4. 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)
How should we evaluate and measure effectiveness?
Rigorous Experimental Methods1. 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
1. Within-subjects designs2. Between-subjects designs3. Meta-analysis
Three suggested methods for measure effectiveness
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)
Within-subjects designs
Single-Case & Group Experimental Designs2) 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
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
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
Between-subjects designs
2) Types of Randomized Clinical Trialsa) 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
d) Comparing Multiple Interventions E.g., behavior therapy, meds, behavior
therapy+meds, wait-list control, & placebo
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
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 as1.1. Best Support (“Well-Established Best Support (“Well-Established
Treatments”)Treatments”)
2.2. Promising (“Probably Efficacious Promising (“Probably Efficacious Treatments”)Treatments”)
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).
Criteria for “Well-Established Treatments”
or Best Support
ORII. A large series of single case design
experiments (n > 9) demonstrating efficacy. These experiments must have:a. Used good experimental designsb. Compared the intervention to another
treatment as in I.a. (superior to placebo, etc.)
Criteria for “Well-Established Treatments”
or Best Support
ANDFurther 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.
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.
Criteria for “Probably Efficacious Treatments”
or Promising
ORII. 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).
Criteria for “Probably Efficacious Treatments”
or Promising
ORIII. 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.
ExampleEmpirically Supported Treatment
Behavioral Distress in
Venipuncture and Immunizations
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.
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.
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
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
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
Goals
Distress, Coping, Cooperation
Intervene early to prevent future distress
Find Practical, Cost-Effective Methods to Alleviate Distress
Reviewed Psychlit, Pubmed
Over 20 Intervention Studies Wide range of treatment populations Predominant Component: Distraction
Caveat: only reviewed up until 2001
Literature Review
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
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
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”
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 Reassurancec) Maternal Non-Procedural Talk (Distraction)
Outcome: Distraction Associated with Distress & Crying, compared to Reassurance & Control
“Promising” Inadequate sample size per group
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
moviec) Nurse + Parent/Child Intervention:
- modeling and role playing prior- nurse + parent coaching during movie
Outcome: both interventions Distress, restraint, coping
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) Standardb) Distraction + Nurse Coach: cartoon moviec) EMLA: lidocane + prilocane applied 1hr prior
Outcome:Distress, coping: cartoon + coachingChildren coped better with standard than EMLA
Coaching to watch cartoon “Promising” b/c lack of multiple research teams/authors
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
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
Anxiety Disorders
“Well-Established Treatments”
“Probably Efficacious Treatments”
Specific Phobia
1. Participant Modeling*2. Reinforced Practice*
1. Cognitive Behavior Therapy2. Systematic Desensitization*
Generalized Anxiety Dx(GAD)
None 1. Cognitive Behavior Therapy2. 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
Depressive Disorders
“Well-Established Treatments”
“Probably Efficacious
Treatments”
Major Depressive Disorder
1. Interpersonal Therapy
1. CBT2. Psychotropic
MedicationsDysthymic Disorder 1. Interpersonal
Therapy1.CBT2.Psych Med
Adjustment Disorder 1. Interpersonal Therapy
1.CBT2.Psych Med
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
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 Therapy2. Problem Solving Skills
TrainingFor Adolescents:1. Anger Control Training
with Stress Inoculation2. Assertiveness Training3. Multisystemic Therapy4. Rational Emotive
Therapy
Cognitive Behavioral Therapy
“Probably Efficacious Treatment” Specific Phobia Generalized Anxiety Disorder (GAD) Separation Anxiety Major Depressive Disorder Dysthymic Disorder Adjustment DisorderWhile not meet EST criteria, also often used for Agoraphobia, OCD, Panic Disorder, PTSD,
Social Phobia
What is CBT?
Therapeutic technique that uses a combination ofA. 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.
B. 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)
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
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
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
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
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
Cognitive Theory
The Cognitive Triad1. 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
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……
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
From Cognitive Theory to Intervention
Ellis’ A-B-C-D-E theory D-dispute irrational beliefs E-evaluate effects (reduction of
depression, anxiety)
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
Possible Components of CBTor Techniques used as part of
CBT
Cognitive Reframing Relaxation Training
1. Diaphragmatic Breathing2. Imagery 3. Progressive Muscle Relaxation4. Iatrogenic Relaxation
Modeling In vivo exposure Reinforced practice Social and Communication skills training Problem-solving training Anger-management training
Behavioral Strategies
Generally, behavior therapy emphasizes changing behavior by changing the antecedents or consequences, or learning new behavior-based skills
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 Relaxation4. Autogenic Relaxation5. Biofeedback
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
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
Behavioral Strategies
Participant Modeling Combines modeling and in vivo
exposure1. 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.
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.
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
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
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.
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
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.
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
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
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
HAPPY HALLOWEE
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