the efficacy of a transdiagnostic emotion-focused exposure ... · the efficacy of a transdiagnostic...

The efficacy of a transdiagnostic emotion-focused exposure

treatment for chronic pain patients with comorbid anxiety and

depression.

A randomised controlled trial

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• Marked co-occurrence between chronic pain

and emotional problems

• Difficult to address parsimoniously and

effectively with available treatment options.

Why?

• Systemic problems

• Suboptimal results

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3

-2,5

-2

-1,5

-1

-0,5

0

0,5

1

1,5

2

2,5

LO32.1%

PF33.3%

SA19.5%

CO11.4%

SPSQ TSK

Wurm, Edlund, Tillfors & Boersma (2016). Scandinavian Journal of Pain

For pain patients with high levels of emotional problems,

CBT oriented pain treatments are generally less effective

- Chronic spinal pain

- CBT oriented multimodal rehabilitation

-1

-0,5

0

0,5

1

1,5Anxiety sensitivity

Negative affect

Anxiety

DepressionPain interference

Pain intensity

Low Return to workself-efficacy

PF-SA SC PF LO

Problem levels post TREATMENT

Wurm et al. 2016

For pain patients with high levels of emotional problems, CBT oriented

pain treatments are generally less effective

Emotional distress & cognitive behavioral factors

prognostic

5

Need for treatment innovation

• Important to test new treatment modalities for pain

patients with high levels of emotional problems

• Can we treat both emotional and pain problem simultaneously?

• Improve our theoretical understanding of the basis

for this comorbidity

• How do pain and emotion relate?

• A transdiagnostic perspective

• Emotional dysregulation

6

Transdiagnostic processes mutually reinforcing

and maintaining emotional dysregulation

Distress

Pain

problem

Emotional

problem

Functional impairment

EMOTION

REGULATION

Adapted from mutual maintenance model. From Sharp TJ, Harvey AG: Chronic pain and posttraumatic stress disorder: mutual maintenance?

Clinical Psychology Review 2001;21(6):857–77, p. 870

Hybrid exposure treatment for chronic

pain (Hybrid)

• Combines exposure in vivo methods for chronic pain based

on the fear-avoidance model with an emotion regulation

approach informed by procedures in Dialectical Behavior

Therapy (DBT).

- Validation (soothing emotions), dialectics (acceptance vs

change)

- Extensive (emotion regulation) skills training

- Exposure to feared movements and activities but also to

any other relevant target/stimulus

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Hybrid (10-15 sessions)

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Treatment stageI. Building a working relationship, soothing distress and developing relevant goals II. Developing skills to prepare for exposure and improve regulation of pain and emotion in everyday lifeIII. Exposure for emotions and movementsIV. Training context sensitivity; applying skills in tune with environmental demandsV. Maintaining and refining

iCBT (8 modules)

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Module, theme1: Introduction, pain education2: Coping with pain through graded exercise3: Coping with pain through behavioral strategies4: Coping with pain through cognitive strategies5: Mindfulness6: Stress and pain7: Sleep and pain8: Maintanance

Method

Randomized controlled trial

Chronic pain patients with co-occurring emotional problems

received either:

1. An individual treatment targeting processes that have

been shown to maintain emotional dysregulation

(Hybrid).

2. An active comparison condition receiving internet-

delivered pain management treatment based on CBT

principles (iCBT).

3. Outcome measured pre, mid, post treatment and 9

month follow up

The Ethics Review Board in Uppsala approved the study (2015/479), trial was preregistered at Clinicaltrails.gov (NCT02808286).

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Sample characteristicsHybrid (n=58) iCBT (n=57)

Gender N (% women) 52 (89.7%) 44 (77.2%)

Age (mean (SD)) 45 (12) 44 (12)

Pain locations

▪ Back, neck and/or shoulders

▪ Legs and arms

▪ Other areas

58 (100%)

58 (100%)

16 (27.6%)

57 (100%)

57 (100%)

15 (26.3%)

Pain duration (median years (IQR)) 11 (11) 9 (12)

Education N (% university or above) 22 (37.9) 23 (40.4)

Occupational status (N (%))

▪ Working

▪ Unemployed

▪ Student

▪ Pensioner

▪ Other

33 (56.9%)

3 (5.2%)

3 (5.2%)

9 (15.5%)

10 (17.2%)

34 (59.6%)

4 (7%)

4 (7%)

6 (10.5%)

9 (15.8%)

Sick leave (N, % during last year)

▪ 0-14 days

▪ 15-180 days

▪ 181-365 days

25 (43.1%)

8 (13.8%)

25 (43.1%)

25 (43.9%)

11 (19.3%)

21 (36.8%)

Self reported diagnose

Diagnose (self-reported)▪ Fibromyalgia

▪ Chronic pain, not further specified

▪ Whiplash

▪ Other

20.7%58.6%10.3%10.3%

26.6%45.3%7.8%

20.4%

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Hybrid (n=58) iCBT (n=57)

Psychiatric comorbidity (MINI-criteria)¹

▪ Not fulfilling disorder criteria

▪ Major depressive disorder

▪ Anxiety disorder

▪ Comorbid depressive and anxiety disorder

▪ Neuropsychiatric impairment ²

(n=52)

16 (30.8%)

24 (46%)

29 (55.8%)

17 (32.7%)

3 (5.8%)

(n=55)

23 (41.8%)

21 (38.2%)

24 (43.6%)

13 (23.6%)

1 (1.8%)

Screening measures (mean (SD))

▪ Function (ÖMPSQ) (0-40)

▪ HADS anxiety (0-21)

▪ HADS depression (0-21)

21 (7.5)

12.2 (4.0)

11.4 (3.8)

21.7 (7.3)

11.2 (4.1)

11.8 (4.3)

Questions

1. Is the hybrid treatment acceptable and well received by

patients?

2. Does a hybrid treatment lead to a decrease in comorbid

emotional symptoms, and an increase in functional ability?

3. Does a hybrid treatment lead to better treatment effect on the

above outcome variables compared to the active comparison

group?

4. Are therapeutic effects of the hybrid treatment mediated by

changes in emotion regulation?

5. Are therapeutic effects or the mediation of effects moderated by

patient characteristics (specifically: severity of emotional

problems)?

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Hybrid iCBT

Satisfaction (0-10), median (IQR) 9 (2) 7 (5)***

Global improvement (0-10), mean (SD)

6.6 (2.1) 4.9 (2.4) **

Adverse events reported, n (%) 6 (13%) 11 (26.2%)

Acceptibility ratings

21

Patient self reported impression of global improvement

22

0 10 20 30 40 50 60 70 80

Drop-out before treatment start

  < 25% completed

25-75% completed

>75 completed

% treatment completed

iCBT Hybrid

Results

Both groups improve:

Hybrid treatment within-group effect sizes ranging from d=0.35

(pain intensity) to d=1.01 (depressive symptoms) at post-treatment

and from d=0.40 (pain intensity) to d=1.17 (pain interference) at

follow-up.

iCBT within-group effect sizes ranging from d=0.31 (pain intensity)

to d=0.76 (depression) at post-treatment and d=0.60 (anxiety) to

d=0.73 (pain catastrophizing) at follow-up.

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Results: differences between conditions, FU

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0

10

20

30

40

50

60

70

80

Hybrid iCBT

% moderately to severlydepressed

% pre moderate to severe depressive symptoms

% FU moderate to severe depressive symptoms

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0

10

20

30

40

50

60

70

80

90

Hybrid iCBT

% likely anxiety disorder

% pre likely anxiety disorder % FU likely anxiety disorder

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0

5

10

15

20

25

30

35

40

45

Hybrid iCBT

% clinical level pain catastrophizing

% pre clinical level catastrophizing

% FU clinical level catastrophizing

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Preliminary results: emotion regulation mediated

differential improvement on depression

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Conclusions

• Acceptable and effective in incrementily changing interference,

depression and possibly catastrophizing

• Preliminary: emotional improvement mediated by change in

emotion regulation skills

• Preliminary: most benificial for patients with comorbid disorders

of clinical level

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Future

• Implementation

• What context?

• Improvements in the protocol?

• Possible in (possible) other formats, including otherprofessions?

• Training and competency.

• Future scientific work

• Further analyse and publish mediation and moderation

• Explore the role of context sensitivity

• Record linkage to further explore effects on medication use and work ability.

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Future work

0369

12151821242730333639424548515457606366697275

Hybrid iCBT

Medication use at 9 months FU

opioids psychofarmaca

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Opioids Psykotropic Op + Psyk

Madras hi/low 6,53 (CI 2.31-18.46)* 2,77 (CI 1,05-7,22)* 8,09 (CI 1.52-42.88)*

PCS hi/low 1,98 (CI 0.74-5.30) 3,00 (CI 1.16-7.80)* 2,15 (CI 0.50-9.24)

GAD hi/low 1,48 (CI 0.52-4.24) 2,57 (CI 0.95-6.94) 1,83 (CI 0.40-8.30)

LISAT hi/low 0,50 (CI 0.18-1.33) 0.74 (CI 0.30- 1.86) 0.59 (CI 0.13-2.61)

MPI-Interference hi/low 4,39 (CI 1.46-13.21)* 3,26 (CI 1.20-8.82)* 3,07 (CI 0.59-16.09)

Katja Boersma, ÖU, CHAMP

Steven Linton, ÖU, CHAMP

Ida Flink, ÖU, CHAMP

Martin Södermark, Liu, rehabcenter Lnkp

Sara Nygren, ÖU, CHAMP

Ester Klein Strandberg, ÖU, CHAMP

Maria Lind, rehabcenter USÖ

Marie Blom, rehabcenter Lnkp

Alan Fruzetti, University of Nevada

Mark Lumley, Wayne State University

Thomas Overmeer, Mälardalen Högskola

Monica Buhrman, Akademiska, Uppsala

Björn Gerdle, Linköping University