Cognitive behavioural therapy

National Clinical Guideline Centre (UK)

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Update information September 2017: The guideline has been revised throughout to link to MHRA advice and NICE technology appraisals that have been completed since original publication. Minor updates since publication August 2019: Links to the MHRA safety advice on the risk of using retinoids in pregnancy have been updated to the June 2019 version.

14Cognitive behavioural therapy

Publication Details

Psoriasis is a complex long-term condition that can make substantial physical and psychological demands on the patient¹⁰⁷. Over a third of people with psoriasis report clinically significant anxiety and depression and levels of suicide ideation are increased in psoriasis. Less is known about actual suicide attempts.

Social embarrassment and rejection are common and this psychological and social impact results in reduced quality of life and lower levels of psychological wellbeing. The magnitude of impact on quality of life for people with psoriasis is thought to be similar to other long term conditions such as diabetes, cancer and cardio-vascular disease. Cross-sectional work has shown that distress affects clinical outcomes possibly through behavioural and biological pathways, reducing coping, impairing self-care and increasing non-adherence, this latter finding is particularly relevant to use of topical treatments in psoriasis. Furthermore, some studies suggest distress may actually trigger a psoriasis flare.

High levels of distress and poor coping are underpinned by a set of beliefs that are both general - about the person themselves, and their ability to manage a long-term condition, plus specific beliefs about the condition itself. These beliefs are useful predictors of self-management and form important targets for psychological treatment intervention designed to challenge and change them.

The NICE clinical guideline on depression²⁶³ in adults includes recommendations on the use of cognitive behaviour therapy (CBT) for patients with low mood and depression and a long-term physical condition.

Access to psychological therapies has been, and continues to be, problematic as demand outstrips supply with many eligible patients waiting for long periods to access suitably trained therapists. Dedicated psychological service provision for patients with psoriasis only exists in highly specialised settings. More often, patients are referred to general mental health services and assessed according to standard mental illness criteria and therefore psoriasis specific issues may be missed. Patients are often reluctant to use mental health services partly due to the social embarrassment they experience living with psoriasis and partly because non-specialists do not understand or address key aspects of the condition sufficiently for them.

The GDG posed the following question: in people with psoriasis (all types), how effective are cognitive behavioural therapy (CBT) (group and individual) interventions, alone or as an adjunct to standard care, compared with standard care alone for managing psychological aspects of the disease in reducing distress and improving quality of life?

14.1. Methodological introduction

A literature search was conducted for RCTs, systematic reviews or comparative observational studies that addressed the efficacy of cognitive behavioural therapy in people with psoriasis for managing the psychological aspects of the condition compared with standard care (the pharmacological intervention usually received by a person with psoriasis of a given severity and/or educational interventions). Note that CBT was prioritised for review because it has been studied with more rigor than other psychological interventions in psoriasis.

No time limit was placed on the literature search and there were no limitations on sample size or duration of follow-up. Indirect populations were excluded.

The outcomes considered were:

Reduced distress, anxiety or depression (assed by change in Hospital Anxiety and Depression Scale (HADS), Beck Depression Inventory (BDI) or Speilberger State Trait Anxiety Inventory (STAI))
Reduced stress (change in Psoriasis Life Stress Inventory [PLSI])
Improved quality of life (change in Dermatology Life Quality Index [DLQI] or Psoriasis Disability Index [PDI])
Reduced psoriasis severity (change in PASI).

One study¹⁰⁶, was found that addressed the question and was included in the review. Note that no studies were available that assessed cognitive behavioural therapy in an exclusively paediatric population.

The study design used patient-preference randomization and so was classified as a non-randomised controlled study. The intervention was a 6-session CBT programme delivered by medical, clinical psychology, and nursing personnel, called the Psoriasis Symptom Management Programme (PSMP), which lasted 2.5 hours. This consisted of didactic teaching about the medical and biological basis of psoriasis, stress-reduction techniques, cognitive techniques and homework in relation to individual perceptions as an adjunct to standard care. The comparison group received standard care, which included topical and systemic non-biological therapy.

14.2. Cognitive behavioural therapy vs. standard care

14.2.1. Evidence profile

Table

Although the t-values and p-values reported in the GRADE table were unadjusted for confounders, the study did report the results of repeated-measures ANCOVA with baseline scores included as covariates. This analysis was reported to show statistically significant effects of the intervention compared with standard treatment for PASI (p=0.001), anxiety (p=0.001), depression (p=0.001), psoriasis-related stress (p=0.001) and disability (p=0.04). However, it was not clear whether this was based on the 6 week or 6 month time-point or whether it was for a comparison of final or change scores.

The study did not report full details for the majority of outcomes, which were mainly presented graphically only. However, to aid clinical interpretation the available data are presented below to provide contextual information about the approximate magnitude of change in both groups relative to baseline values (see Table 168). Note that the study did not report mean scores as assessed by Psoriasis Disability Index or the depression scores from HADS.

Table 168

Clinical severity, anxiety and stress scores at baseline, 6 weeks and 6 months follow-up.

14.2.2. Evidence statements

In people with psoriasis, the cognitive behavioural therapy group had a significantly lower mean score than standard care (P<0.05) for:

PASI75 at 6 months [1 study; 58 participants; very low quality evidence]¹⁰⁶
Final PASI at 6 weeks [1 study; 93 participants; very low quality evidence]¹⁰⁶
Clinical severity as measured by PASI at 6 months [1 study; 93 participants; very low quality evidence]¹⁰⁶
Disability as measured by PDI at 6 weeks and 6 months [1 study; 93 participants; very low quality evidence]¹⁰⁶
Depression as measured by HADS at 6 weeks and 6 months [1 study; 93 participants; very low quality evidence]¹⁰⁶
Anxiety as measured by HADS at 6 weeks and 6 months [1 study; 93 participants; very low quality evidence]¹⁰⁶
Stress as measured by PLSI at 6 weeks and 6 months [1 study; 93 participants; very low quality evidence]¹⁰⁶

14.3. Economic evidence

No relevant economic evidence was identified.

14.4. Recommendations and link to evidence

Table

Does a psoriasis-specific cognitive behavioural therapy intervention improve distress, quality of life and psoriasis severity compared with standard care? Reduced distress/anxiety/depression

Publication Details

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Publisher

Royal College of Physicians (UK), London

NLM Citation

National Clinical Guideline Centre (UK). Psoriasis: Assessment and Management of Psoriasis. London: Royal College of Physicians (UK); 2012 Oct. (NICE Clinical Guidelines, No. 153.) 14, Cognitive behavioural therapy.

Quality assessment							No of patients		Effect		Quality
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Cognitive behavioural therapy	Standard care	Relative (95% CI)	Absolute	Quality
PASI75 (follow-up 6 months)
1 Fortune 2002B	observational studies^a	very serious^b	no serious inconsistency	no serious indirectness	no serious imprecision	none	18/28 (64.3%)	7/30 (23.3%)	RR 2.76 (1.36 to 5.58)	411 more per 1000 (from 84 more to 1000 more)	⊕○○○ VERY LOW
Final PASI (follow-up 6 weeks; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^b	no serious inconsistency	no serious indirectness	serious^c	none	40	53	-	MD 1.9 lower (3.66 to 0.14 lower)	⊕○○○ VERY LOW
Clinical Severity (PASI) (follow-up 6 months; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^d	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 2.0 lower^f	⊕○○○ VERY LOW
Disability (PDI) (follow-up 6 weeks; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^g	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 3.33 lower^h	⊕○○○ VERY LOW
Disability (PDI) (follow-up 6 months; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^g	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 3.05 lowerⁱ	⊕○○○ VERY LOW
Depression (HADS) (follow-up 6 weeks; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^d	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 4.7 lower^j	⊕○○○ VERY LOW
Anxiety (HADS) (follow-up 6 weeks; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^d	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 2.8 lower^k	⊕○○○ VERY LOW
Depression (HADS) (follow-up 6 months; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^d	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 3.29 lower^h	⊕○○○ VERY LOW
Anxiety (HADS) (follow-up 6 months; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^d	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 2.92 lower^l	⊕○○○ VERY LOW
Stress (PLSI) (follow-up 6 weeks; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^d	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 3.9 lower^j	⊕○○○ VERY LOW
Stress (PLSI) (follow-up 6 months; Better indicated by lower values)
1 Fortune 2002B	observational studies^a	very serious^d	no serious inconsistency	no serious indirectness	serious^e	none	40	53	-	t-value 3.06 lower^m	⊕○○○ VERY LOW

a: Patient-preference randomisation, no blinding, no allocation concealment

b: High dropout rate and not matched for concomitant therapies

c: Serious imprecision according to GDG discussion (confidence interval ranges from clinically important benefit to no clinically important benefit)

d: Incomplete reporting, high dropout rate and not matched for concomitant therapies

e: No measure of variance provided

f: p=0.04

g: Intervention and control not matched at baseline, incomplete reporting, high dropout rate and not matched for concomitant therapies

h: p=0.001

i: p=0.003

j: p<0.001

k: p=0.007

l: p=0.004

m: p=0.003

Table 168Clinical severity, anxiety and stress scores at baseline, 6 weeks and 6 months follow-up

Time point	PSMP	Standard care	p-value
Change in PASI (mean ± SD)
Baseline	10.5 ± 2.7	9.2 ± 3.2	NS
6 weeks	6.5 ± 4.1	8.4 ± 4.5	0.03
6 months	6.5	8.0 ± 4.8	0.04
HADS (anxiety)
Baseline	12	12	NS
6 weeks	8	11	0.007
6 months	8	11	0.004
PLSI (stress)
Baseline	21	25	NS
6 weeks	15	24	<0.001
6 months	15	23	0.003

Recommendations on cognitive behavioural therapy	No recommendations.
Future research recommendations	27. Does a psoriasis-specific cognitive behavioural therapy intervention improve distress, quality of life and psoriasis severity compared with standard care?
Relative values of different outcomes	The following outcomes were considered by the GDG and given equal weight: Reduced distress/anxiety/depression Reduced stress Improved quality of life Reduced psoriasis severity
Trade off between clinical benefits and harms	There was only one small UK CBT study that was situation specific to people with psoriasis. The GDG noted that whilst the data did not suggest any major effect on PASI, importantly CBT reduced the HADS score and distress. The GDG had low confidence in the study results, all outcomes were considered to be of low or very low quality. Given this the GDG made a future research recommendation.
Economic considerations	No economic evidence was available to inform the GDG on the cost-effectiveness of cognitive behavioural therapy in the management of patients with psoriasis. The GDG discussed the significant psychological impact psoriasis can have on patients’ quality of life and generally believed that CBT or other psychological interventions may help some patients; however, on the basis of inconclusive clinical evidence, they could not be sure that this would represent good value for NHS resources. They felt that further research was warranted in order to measure clinical and quality of life benefits associated with psychological interventions and also to better identify patients who might gain the most from such interventions.
Quality of evidence	There was a paucity of data as only one study was identified (Fortune 2002B). This study used a patient preference allocation design, which means participants were given the choice as to which arm of the study to enter. This method is often used in psychological trails to reduce drop outs. All participants were given CBT sessions at the same site with the same people delivering the CBT. The GDG noted the following issues with the quality of the study: The groups were not matched at baseline for disability scores There were substantial drop outs in both groups There were differences in the prescribed treatments, which potentially may confound some of the results Incomplete reporting (actual changes scores were not reported for some scales) Very low quality evidence rating for all outcomes. Additionally, more people in the CBT group converted from topicals to systemic therapies, while the proportions did not change much in the standard care group. Therefore, improvement in PASI could be due to changes in treatment. The GDG acknowledged that moving to systemic treatment could explain the improved PASI, but this does not mean that CBT has not helped. There appeared to be a discrepancy between the small difference in final PASI and the clinically significant improvement in the numbers achieving PASI75 in the CBT group. It was discussed that this may be explained by a high percentage of people achieving 71–74% improvement in the control group and being classified as not achieving PASI75; alternatively it may be due to the difference in baseline PASI between the two groups (1.3 points higher in the CBT group). The GDG did not wish to make a national recommendation due to the lack of evidence. The GDG agreed to make a future research recommendation on whether CBT is of value. Future research should take into account disease severity and distress at baseline.
Other considerations	The GDG discussed whether it is possible to separate the impact of the educational component from other aspects of CBT. The GDG were aware that in cardiovascular disease and diabetes, it is known that an educational component is not enough to manage psychological distress and poor coping. Although educational strategies will help alleviate distress, a clinical effect may not be achieved without a cognitive-behavioural element. The separate effects of education and CBT are unknown for psoriasis. The GDG discussed whether improvement in anxiety and depression may help self-management, or vice versa. The GDG were aware of research work investigating whether managing depression dampens the psoriasis inflammatory response.