Journal Club8/12/2014DR CALEB CHAN

Journal Article

Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomized controlled trial

British Journal of Psychiatry. 2014 Nov 27. pii: bjp.bp.114.150243. [Epub ahead of print]

Background

Number of meta analysis and RCT since 2007 have demonstrated efficacy for minufulness based psychotherapy for recurrent Major Depression.

Current UK NICE guidelines: Mindfulness (MBCT) for use on Major Depression with 3 or more relapse.

No significant data for comparison of mindfulness versus CBT

CBT trained instructors in short supply

Mindfulness requires shorter duration train

May be a cost benefit advantage over CBT.

Aim

To compare the effect of:

Structured mindfulness-based group therapy vs “treatment as usual” (mostly CBT).

In patients with diagnoses of:

Depressive Disorder

Anxiety and stress

Adjustment Disorders

Design

Conducted in Sweden.

24 GP practices across the county of Skåne randomly selected and invited to participate.

17 interested and 1 dropped out. (n=16)(participation rate 76%)

Participating GP then recruit patients satisfying the inclusion and exclusion criteria.

Outcomes measured in self reporting symptoms in MADRS-S or HADS-A or HADS-D, or PHQ-9 .

Instructors recruitment

30 instructors in total recruited and trained over 6 days.

Passed “oral exam”, and became “certified mindfulness instructors”

Background of psychologist, social workers, nurses, physiotherapists and doctors.

Inclusion Criteria 1) Newly diagnosed and past history are both eligible

2) “Those who sought treatment”

3) One of more of the following ICD-10 diagnoses

- Mind Depressive Episode

- Moderate Depressive Episode

- Depressive Episode, unspecified.

- Recurrent depressive disorder, mild

- Recurrent depressive disorder, modeate

- Panic disorder

- Generalised anxiety Disorder

- Mixed anxiety and depressive Disorder

- Other Mixed anxiety Disorders

- Other specified anxiety Disorders

- Anxiety Disorder Unspecified

- Adjustment disorders

- Other reaction to severe stress

- Reaction to severe stress, unspecified

Inclusion Criteria continued…

4) Age 20-64

5) Speak and read Swedish

6) MADRS-S 13-34 or HADS-A or HADS-D ≥7, or PHQ-9 ≥10

Exclusion Criteria

1) “Severe psychiatric symptoms requiring psychiatric care”

2) Risk of suicide

3) “Inability to participate at group sessions due to substance use”

4) Pregnancy

5) Receiving current psychotherapy of any kind.

6) Participation in any other psychiatric intervention study

7) Thyroid disease

Randomisation

Numbers 1-20 given to each practice

Allocated to each number in order of participant signing the consent form

Each number corresponded to intervention or control.

Not allowed to change group once allocated.

Allocation masked to investigators.

Each randomized patient completes all 3 self rated scales.

Intervention

Based on Mindfulness-based stress reduction (MBSR) and Mindfulness-based cognitive therapy (MBCT).

Patients are prescribed psychotropics for treatment if necessary.

Period of intervention varied between sites.

2 hour sessions each week, up to 8 weeks.

20mins/day self practice.

Assessment of symptoms immediately after the 8-week intervention.

Control

Treatment As Usual (TAU)

“Sometimes included pharmacological treatment”

“Most cases also psychotherapy”.

Most in the control group received CBT. (n=80)

Assessment of symptoms immediately after the 8-week intervention.

Drop outs

The main reasons for drop-out were work situation and lack of time. Other reasons included moving house, sickness, no desire for treatment and disappointment at being randomised to the control group. The number of participants who dropped out after the randomisation and baseline examination was higher in the mindfulness group (n = 18) than in the control group (n = 9).

No significant differences in sociodemographic characteristics between those who dropped out and those who remained in the study.

However, those who dropped out scored significantly higher at baseline on all scales than those who remained in the study.

Results

Mean age was 42 and 41 years in the mindfulness and control groups, respectively.

Women as well as those with a middle or high level of education were in the large majority in both groups.

Around two-thirds were married.

More patients not taking medication than those who were for depression or anxiety.

No significant differences in sociodemographic characteristics or medication between the two groups.

The P-values for treatment with antidepressants and tranquilisers were 0.882 and 0.937, respectively, which indicates that there were no statistically significant differences in pharmacological treatment between the mindfulness and the control group.

Results continued…

The most common therapy in the control group was individual CBT (CBT, n= 80; physical activity therapy, n= 2; none,n = 8.)

There were no significant differences (treatment effects) between the mindfulness and control groups for any of the three scales.

Results continued..

Effect size = 0.4

Non inferiority trial

Null hypothesis:

A difference of 3.5 in MADRS-S score would be considered negligible.

We also performed a non-inferiority analysis in order to test whether the

mindfulness treatment was non-inferior to TAU. We used a 97.5% one-sided confidence interval to examine whether the upper limit exceeded 3.5. This test showed that mindfulness was non-inferior to TAU (upper limit 3.17)

- Effect size 0.4

A sensitivity analysis reported to have completed which shows results unaffected by any influential observations or outliers.

Implications

The present RCT provided evidence that mindfulness group therapy given by certified instructors is non-inferior to individual-based CBT.

Mindfulness has significant cost effectiveness advantages as instructors can be qualified in 6-8 weeks, and can come from a variety of medical or academic backgrounds.

Strengths

Use of multiple scales to assess symptoms improve generalizability and robustness

Rate of antidepressant and tranquilisers show no statistically significant difference across both groups, despite “TAU” criteria in control group.

Clear documentation of drop outs and reasons.

Power analysis shows the results sample size is big enough to reflect any statisitcally significant changes in outcome measures. Numbers required is 83 in each group

Intervention group n= 81-83

Control group n= 85-86

Strengths continued…

Demonstrates under study specified conditions, Mindfulness is non inferior to RCT.

Weaknesses

Setting limited to GP practice.

Inclusion criteria includes both depressive and anxiety disorders.

Exclusion criteria of “severe psychiatric symptoms” is not objective, which may introduce bias into either group.

Objective inclusion criteria for self report symptoms scale score in HADS-A,D and PHQ-9 does not have a upper cut off.

Baseline depression and anxiety scores shows statistically significant variation between intervention and control group.

Intervention did not use standardized Mindfulness program but one based on both MBCT and MBSR.

No strict criteria for format/fashion of CBT given to control group.

No statistically significant difference between antidepressants in the two groups

Statistically significant higher mean score for

control group MADR-S and HADS-D

High dropout rate 17.8% on intervention group. 9.5% on Control group.

No Blinding in both groups (although not considered feasible in psychotherapy studies)

Results significance limited to 8 weeks post intervention.

No analysis on treatment effect.

Discussion

This is essentially a non-inferiority trial

- Appropriate setting for non-inferiority as benefit of Mindfulness requiring less training.

1) Royal Australian and New Zealand College of Psychiatrists Clinical Practice, “Australian and New Zealand clinical practice guidelines for the treatment of depression.” Australian and New Zealand Journal of Psychiatry 2004; 38:389–407.)

2) Cuijpers P, Berking M, Andersson G, Quigley L, Kleiboer A, Dobson KS. “A meta-analysis of cognitive behavioural therapy for adult depression, alone and in comparison with other treatments. “ Can J Psychiatry 2013; 58: 376-85.