EVALUATION OF PSYCHOTHERAPY

EFFICACY AND SAFETY

Chithra U

Chaired by,
Mr Joseph Noel
Psychotherapy is broadly defined as any
psychosocial intervention intended to aid a
client with mental health or life problems
Efficacy Studies
 Treatment efficacy studies:
 efforts to maximize the internal validity of a study

 This commonly includes the use of design

features, random assignment to treatment and
control conditions

 training of therapists to a specified level of

competence in providing the treatment, and
ensuring that all participants have the condition
that the treatment was designed to address.
Effectiveness studies

 Treatment effectiveness studies

 strive to maximize external validity while

maintaining an adequate level of internal validity

 Efforts to enhance external validity involve

locating the treatment study within clinical service
sites that provide ongoing health services
 DEPRESSION : Efficacy
Studies
 Anderson et al- 147 studies comparing
psychotherapy vs no treatment, the effect size
was d=0.66

 All forms of psychotherapy superior to the

outcomes of the control group

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 Lee et al. (2012) - psychotherapy was a beneficial
treatment for community dwelling, older adults with
sub-syndromal depression

 Fewer depressive symptoms, higher remission rates, and

lower incidence of MDD at 1yr follow-up.

 Similar findings with studies across child and adolescent

group(Weiz et al d=0.34 psychotherapy vs no treatment)

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Treatment of Severe
Depression

 Meta-analysis concluded psychotherapy is more

efficacious for high severity patients(0.39) than for low
severity patients(0.23)

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Psychotherapy vs Antidepressant Medication

 Psychotherapy performs as well as pharmacotherapy

post-treatment,

 At 1-2 year follow-up, psychotherapy had a significantly

lower rate of relapse (26.5%) than did pharmacotherapy
(56.6%)- De Maat et al. (2006) and better follow up rates

De Maat, Dekker, Schoevers,& De Jonghe, 2006; Cuijpers et

al., 2011a; Spielmans, Berman, & Usitalo, 2011). 8
 Drop-out rate was 28.4% for pharmacotherapy versus
23.6% for psychotherapy

 Meta analysis by Spielmans et al. (2011)- At

posttreatment, no significant differences in efficacy
between psychotherapy and medication

 At follow up, psychotherapy was significantly superior to

medication

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Effectiveness Studies

 Meta-analysis by Hans and Hiller (2013) : significant

reductions posttreatment in dysfunctional cognitions,
general anxiety, psychological distress, and functional
impairment

 Hunsley and Lee (2007)- treatments for youth depression

delivered in routine clinical settings can achieve the level
of outcomes reported in efficacy trials.

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BIPOLAR DISORDER
 Psychotherapy alone cannot successfully treat this
disorder

 Evidence suggests that, as an adjunct to mood-

stabilizing medication, it can significantly reduce relapse
rates and improve overall functioning and well-being

 In addition to psychoeducation, Cognitive Behavioural

Therapy (CBT), Family Focused Therapy (FFT), and
Interpersonal and Social Rhythm Therapy (IPSRT) are
effective
 Scott, Colom, & Vieta, 2007; Lam et al., 2009; Szentagotai & David, 2010

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 No evidence that one form of psychotherapy is superior
to another

Efficacy Studies
 40% decrease in relapse rate was found with adjunctive
psychotherapy(OR = .53)

 CBT had little effect on relapse prevention beyond what

was achieved with medication
GENERALIZED ANXIETY DISORDER

 Patients with GAD assigned to CBT were more likely to

have significant reductions in anxiety symptoms

 effectiveness studies for pediatric anxiety disorders were

showed improvement rates comparable to those
reported in RCTs of treatment efficacy.

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SOCIAL ANXIETY DISORDER

 Meta-analyses have shown that both pharmacological

and psychological interventions are efficacious in
treating SAD

 Canton, Scott, and Glue (2012) concluded that there was

little difference in the efficacy of psychotherapy and
pharmacotherapy

 Those who received psychotherapy were more likely to

maintain their treatment gains

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OBSESSIVE COMPULSIVE DISORDER

 CBT with ERP- highest degree of empirical support -

considered as treatment of choice for children,
adolescents and adults

 Results suggest that ERP, CT, and a combination are

efficacious treatments that reduce OC symptoms,
general anxiety, and depression and improve social
adjustment

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PANIC DISORDER

 Early meta-analyses tended to report results favouring

the efficacy of psychotherapy over pharmacotherapy

 At present, there is little direct evidence to suggest that

one class of treatment is superior to the other

 Although pharmacologic treatments demonstrated

better cost-efficacy than CBT at the end of the acute
phase, CBT had the greatest cost-efficacy at both
maintenance and follow-up phases

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Psychotherapy research in India

 Paucity of literature related to psychotherapy process

and outcome research undertaken in our country.

 Balkrishna et al. studied the effect of Patanjali yoga on

‘psycho neuroses’ and found it useful in stress induced
psychological disorders. Better results than drug
treatment

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 Vahia’s studies introducing Patanjali yoga into psychiatry
research was a landmark that led many others to take up
yogic asanas and related yogic concepts for empirical
research in this field

 Kumar and Thomas assessed the effectiveness of brief

psychotherapy in patients with alcohol dependence

 Combination of psychopharmacological treatment with

appropriate psychosocial therapies that is focused on the
specific problem of the patient might provide better
outcome than either of the therapies given alone
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Psychotherapy: Safety
It’s Ayurvedic- So harmless!!
Shortcomings of research in
therapy
 Perceptional bias towards positive rather than negative
effects

 Spectrum of possible negative effects is much broader

than in pharmacotherapy: focus on symptoms but also
on social behaviour

 No consensus on what to call negative: “a divorce can be

both positive and negative, and crying in therapy can
reflect a painful experience but can also be a positive and
therapeutic event”.
 Lack of differentiation between side effects and therapy
failure or deterioration of illness

 Lack of generally accepted instruments for the

assessment of psychotherapy side effects

 no rules on how to plan scientific studies or monitor side

effects in randomized controlled clinical trials

 Effect of common factors

Are psychotherapies efficacious?
 Adolescent depression, where there have been extreme
claims made against the safety and efficacy of SSRIs,
leading to them being blacklisted by the US authorities.

 However the alternatives given that three randomised

CBT trials have not shown efficacy (Elkin et al., 1989;
March et al., 2004; Goodyer et al., 2007)

 Also treatment-emergent adverse effects of a self-harm

nature similar to those reported with drug treatment
have been found (Bridge et al., 2005).
 Few psychotherapy trials have addressed question of
effectiveness in real-world: delivery in large multicentre
studies as opposed to demonstrating efficacy in a few
“expert” sites

 Fewer have utilised a full intention-to-treat analysis with

sensitivity analysis of imputed missing data that properly
accounts for dropouts in trials

 Majority of trials in psychotherapy have assessed efficacy

only on individuals who have completed the course of
therapy (completer analysis).
Safety of psychotherapy
 Psychotherapy is not subject to any strict regulation

 Important aspect of safety relates to abuse of patients by

therapists and vice versa

 An anonymous survey of US psychotherapists revealed

a large minority to have had sexual relations with their
patients.

 Gartrell et al. (1986) found 7% of male and 3% of female

psychiatrists reported sexual contact with patients.
Side effects
Ulf Jonsson et al :: A total of 132 eligible trials were identified.
 Only 28 trials (21%) included information that indicated any
monitoring of harms on patient level.

 Four (3%) of these trials provided a description of adverse

events as well as the methods used for collecting these data.
 Five of the trials (4%) reported adverse events but did not
give complete information about the method

 An additional four reports (3%) briefly stated that no adverse

events occurred, whereas 15 trials (11%) only provided
information on deterioration or indicated monitoring of
deterioration.
 Another way to estimate side effects of psychotherapy are patient
and therapist surveys.

 In a survey with 1504 patients, using a specifically developed

questionnaire with 61 items, Leitner et al found significant
differences between treatment modes.

 Patients reported “burdens caused by therapy” in 19.7% of cases

when treated with CBT, 20.4% with systemic psychotherapy,
64.8% with humanistic psychotherapy, and 94.1% with
psychodynamic psychotherapy. Examples of burdens are that
patients felt overwhelmed in therapy, were afraid of the therapist,
or were afraid of stigmatization.
 An example of a therapist survey is provided by Löhr et al
. They contacted 418 CBT therapists by mail, 232 of
whom filled in a questionnaire.

 Therapists estimated that on average 8% of patients left

their spouse after treatment, which in 94% of cases was
regarded as not to be due to the intervention.
 In summary, there is an emerging consensus that unwanted events
should be expected in about 5 to 20% of psychotherapy patients.

 They include treatment failure and deterioration of symptoms,

emergence of new symptoms, suicidality, occupational problems or
stigmatization, changes in the social network or strains in
relationships, therapy dependence, or undermining of self-efficacy.

 Rates may vary depending on patient characteristics (suggestible

persons), diagnosis (personality disorders), patient expectations
(social benefits), severity of illness (severe depression), therapist
characteristics (demanding) or special therapeutic techniques
(exposure treatment, self-revelation).
Therapist’s safety
 There is also the issue of therapist safety – giving
psychotherapy can be bad for the therapist’s mental health.

 Listening to disclosure of traumas can potentially produce

PTSD by proxy (Gersons,2000)
 Transference causing distress.

 Patients can
 be hostile and threatening
 develop pathological attachment that can disrupt the life
of the therapist and their family through pestering and
even stalking.
On health professionals
 According to the United States Department of Justice's National
Crime Victimization Survey conducted from 1993 to 1999, the annual
rate of nonfatal, job-related violent crime was 12.6 per 1,000 workers
in all occupations.

 Physicians, the rate was 16.2 per 1,000, and among nurses, 21.9 per
1,000.

 Psychiatrists and mental healthcare professionals, the rate was 68.2

per 1,000, and for mental health custodial workers, 69 per 1,000.

  And it appears that these events may happen early in one's career, as
the literature suggests that 40 to 50 percent of psychiatry residents
will be physically attacked by a patient during their four-year training
program
Prevalence of adverse outcomes in
psychotherapy

 Bergin in 1967 coined the term ‘deterioration effect’ to

describe how ‘psychotherapy may cause people to
become better or worse adjusted than comparable
people who do not receive such treatment

 Not only worsening symptoms, but lack of significant

improvement when it is expected and even the
acceleration of ongoing deterioration
 3-10% of patients become worse after psychotherapy

 slightly higher rates (7-15%)for substance abuse

 Difficult to establish the percentage of those who would

have worsened regardless of psychotherapy.
Harmful effects reported for specific
psychotherapeutic interventions

 Werch and Owen reviewed preventive interventions for

substance use in youth and young adults, and found 17
studies with documented negative effects

 Moos suggested that clinicians need to be cautious with

substance-abusing patients when using high-risk
treatment processes such as confrontation, criticism and
highly emotive techniques, because they can exacerbate
primary symptoms, or initiate new symptoms such as
increased anxiety or anger
 Prado et al detailed how interventions may have adverse
effects on families and friends particularly if the
individual undergoing therapy becomes more self-
absorbed or self-centred

 Substantial controversy surrounds psychotherapy for

false or repressed memories
Adverse events that might be non-specific
to the type of psychotherapy

Illness status causes loss of:

 i) the sense of indestructibility (or omnipotence)
 (ii) the competence and completeness of one’s reasoning
 (iii)control over oneself and one’s world

 Illness allowing state of dependency

 Contraction of independent capacity
 Patient remaining in a therapeutic comfort zone
Effect of common factors

 Therapist is so passive or inert as to prevent activation of

such therapeutic ingredients (including hope) or if the
therapeutic setting has limitations

 Prioritizing therapist’s own needs

 Failure to explain why particular model is salient for

treatment

 Continuation of therapy despite doubts about credibility

Psychodynamic psychotherapy:
 Extensive time and frequency creates issue of
dependency
 No short term end point
 Focus on self-exploratory components above real world
issues
 Promotion of external locus of control
 Reflective style portraying as therapist lacking
“empathy”
 Dissonance between inner experience and the
imposed perspective can risk bewilderment and further
instability
CBT and IPT
 IPT concentration on social factors

 CBT concentration on cognitive schema- patients unable

to understand same have their self worth undermined

 Worsening of symptoms in obsessive personalities

Therapist style
 Common factors promoting good outcome are empathy,
respect for the patient, confidentiality, a declared logical
therapeutic rationale, instilling rational hope and
providing a healing setting.

 Therapist who is exploitative, overly narcissistic,

patronizing, uncaring, inattentive, or unable to establish
some congruence with the patient and their world, may
be expected to create a lack of fit and an adverse
outcome
Areas to assess for unwanted
events
 Emergence of new symptoms
 Deterioration of existing symptoms
 Lack of improvement or deterioration of illness
 Prolongation of treatment
 Patient's non-compliance
 Strains in the patient-therapist relationship
 Very good patient-therapist relationship, therapy dependency
 Strains or changes in family relations
 Strains or changes in work relations
 Any change in the life circumstances of the patient
 Stigmatization
Recent Trends
 Ongoing work offers hope for improvement in this respect.

 Linden recently proposed a theoretical framework for side effects of

psychotherapy

 In his paper, Linden presents definitions of unwanted events,

treatment-emergent reaction, adverse treatment reaction,
malpractice reaction, treatment non-response, deterioration of illness,
therapeutic risk, and contraindications.

 This terminology could be useful in the process of systematizing

observations from RCTs. The distinction between treatment-emergent
reactions linked to the treatment and unwanted events unrelated to
the treatment is central.
Ethics in Psychiatry
Ethics in pyschiatry

Therapists are likely to face dilemmas relating

to:
 goals and objectives of therapy
 the boundaries between their different
identities
 the social and political frameworks in which
they work
Goals and objectives of
therapy
 Informed consent
 Differences in patient’s and therapist’s view of goal of
therapy
 The ethical principle is respect for autonomy:
patients should be free to choose or refuse for
themselves what treatment they have
 Complexities-
 Inability to predict the kind of negative effects
 Fluctuating levels of capacity
 True nature of voluntariness
Nonmaleficence: do no harm

 Difficulty in quantification of harm in

psychotherapy
 Needs consideration of time scale and
different perspectives
 Benefits to the patient could be harm and
distress to the other family members or vice
versa
Confidentiality and consent
to disclosure
 Principle of informed consent to disclosure
 Discussion about patient with family members
 Therapist may have to balance the patient's claim to
honesty and confidentiality against a possible harm to
them.

 Consent to use of patient information for research

 increased social emphasis on respect for individual patient
autonomy
 The ethical issue here is that therapists cannot assume that
they own the notes of their meetings, and that only their
views about the process notes need be consulted
In psychiatry
 Patients are mentally distressed

 the psychotherapeutic space has to be a private one, to

enable the patient to explore the most delicate of feelings,
especially those of a potentially shameful nature

 trusting empathic relationship between the therapist and the

patient promotes intimacy

 Boundary setting and maintenance help to establish a secure

space to look at what goes wrong with intimacy, and help to
think about different ways of managing interpersonal
relating
Boundaries in psychotherapy

 In medical ethics, the boundary is between personal and

professional identities

 The doctor (generally) undertakes not to bring his

personal identity into the professional space.

 The patient is vulnerable as a result of their illness and

disease, and may be less able to protect themselves
 All psychotherapists have experience of situations where
judicious self-disclosure is immensely helpful to the
therapeutic process (Yalom, 1986, 2002)

 The principle of saying less rather than more

 Negative effect in rigidly refusing to say anything about

oneself
Boundary violations and
crossings
 Crossings
 time keeping: lateness, earliness, alteration, or
cancellation of sessions without notice
 self-disclosure
 discussions of patient material with others, even
with consent
 arguments or jokes with patients
 accidental/unexpected contact outside sessions
 any physical contact
violations
 abrupt termination of therapy by therapist without
warning

 excessive self-disclosure; especially of therapist's distress

or anxiety

 prolonged or repeated angry outbursts with patient

 speaking or responding in ways, which humiliate or

demean
 coercive behavior
 financial exploitation
 planned contact outside therapeutic setting
 all physical contact that is prolonged or repeated
 any sexual or erotic contact between therapist and
patient
 negligent therapy
 Boundary crossings may or may not be harmful.

 Boundary violations :
 cause harm to the patient
 involves an exploitation of the power difference and the
trust between the therapist and the patient

 Boundary violations are not only harmful; they also

represent a wrong done to the patient.

 Boundary violations may therefore have legal

repercussions.

 Therapists may be sued for negligence or malpractice

Management
 Identification of boundary crossing is
happening
 Many ways of responding, and the decision-
making process must be both ethical and
psychodynamic
 The therapist has to formulate an
understanding of what this boundary crossing
is about for the patient, in order to match
their response.
 Boundary crossing
 If aggressive in nature- patient is anxious, and needs a
reassuring response.
 Caring or affectionate type of crossing - patient needs
reassurance that the therapist can keep the boundaries
firmly

 Therapist will be helped if they discuss the issue with

supervisors and colleagues

 Reviewing of technical and communication skills.

Boundaries & confidentiality
 In ethical terms, the therapist's duty to preserve confidentiality is
challenged by

 a therapist's duty to the public good and the social realm

 the possible harms that may ensue if nothing is done.

 The Tarasoff case

The court's legal response to the therapist's dilemma was to find that
the duty to public safety outweighed the duty to preserve the
patient's confidentiality, and that the therapist should disclose
information that indicates risk to others, even in the face of patient
refusal.
Duties of the therapist
 Good ethical and legal case for the therapist breaching
confidentiality
 where she perceives that there is a high risk of
imminent harm to identifiable others

 where the disclosure may reduce the risk of harm

 social benefit in preventing harm (probably) outweighs

the harm and wrong done to the patient
Existing codes & guidelines
 Ethical duties of psychotherapists are the same as other
doctors as detailed in Good medical practice (GMC,
1995).

 Ethical guidance for psychiatrists is also set out in the

World Psychiatric Association Declaration of Madrid
(WPA, 1996).

 The WPA has also set out ethical guidance in relation to

sexual boundary violations (WPA, 2002).
summary

 While the need for adequate reporting of harms in

clinical trials has repeatedly been emphasized, it is
uncertain whether such information is routinely collected
and reported in trials within this research field.

 Guidelines on how to define, detect, and report harms

related to psychological interventions could facilitate
better reporting
 The complexity of the interventions and outcomes of
psychological interventions thus call for conceptual
definitions of potential harms, in order to facilitate
adequate and unambiguous reporting.

 Information about benefits as well as risks needs to be

available in order for patients to make an informed
choice to engage in psychological treatment
Conclusion

 The conversation is not simply a means of developing

rapport and conducting an assessment to yield a
diagnosis—it is the treatment

 It is efficacious for a broad range of psychiatric disorders.

 However, efficacy and effectiveness studies have not yet

clearly shown one kind of psychotherapy to be
consistently superior to another

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Evidence-supported treatment status requires
 examination of efficacy
 analysis of how well these interventions translate
into real world contexts
 Transportability
 Should include both their clinical effectiveness and
risk of adverse events.
 Fit the therapy to the patient and not patient to the
therapy

 Create a balance between complete dependency and

appearing “cold and distant”

 Psychotherapy is an efficacious cornerstone of current

practice.

 The very potency of such therapy gives rise to risks that

may not have been adequately appreciated, and thus
there has been a tacit assumption by practitioners and
patients that psychotherapy is largely devoid of risks.
Thank you!

 References:
 The elephant on the couch: side-effects of
psychotherapy Michael Berk, Gordon Parker
 Uncritical positive regard? Issues in the efficacy and
safety of psychotherapy David J. Nutt
 The Efficacy and Effectiveness of Psychological
Treatments Dr. John Hunsley
 Oxford Textbook of Psychotherapy 1st edition
contributions
 Disagreement regarding outcome
 Influence of common factors- factors in therapist, patient’s motivation
 Issue of placebo- any form of contact can have an impact on outcome
 Allegiance affect
 Matching patient with treatment
 Generalisation of studies
 Boundary crossing- may/may not be intended by therapist
 Self disclosure
 Absolute boundary- sexual relation, financial exploitation, gossip
 Malpractice – evidence of existing relation, deviation of usual care, damage has been done, present treatment
caused the damage