Condition category
Mental and Behavioural Disorders
Date applied
06/07/2009
Date assigned
18/09/2009
Last edited
03/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Morriss

ORCID ID

Contact details

Institute of Mental Health
Floor B
The Sir Colin Campbell Building
University of Nottingham
Triumph Road
Nottingham
NG7 2TU
United Kingdom
+44 (0)115 823 0427
richard.morriss@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09006

Study information

Scientific title

Randomised controlled trial of group psychoeducation versus group support using both expert patients and clinical staff in the management of bipolar disorder

Acronym

PARADES

Study hypothesis

1. To determine the clinical and cost effectiveness of joint expert patient and health professional-led group psychoeducation for bipolar disorder
2. To demonstarte that such group psychoeducation is feasible and sustainable across different NHS sites
3. To determine that group psychoeducation is clinically and cost effective compared to group support
4. To identify barriers and potential solutions to barriers to the implementation of effective group psychoeducation

Ethics approval

National Research Ethics Service Nottingham Research Ethics Committee 2, 20/03/2009, ref: 09/H0408/33

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Bipolar disorder

Intervention

1. Bipolar Group Psychoeducation Intervention:
The group will be run by three facilitators, two health professionals (usually one experienced and one in training), specially trained for the purpose; and one expert patient, also specially trained. The group psychoeducation programme will have 21 sessions, running for 90 minutes:
1.1. Meeting the group and what is bipolar disorder
1.2. Causes of bipolar disorder and triggers for relapse
1.3. Symptoms 1: Mania and hypomania
1.4. Symptoms 2: Depression and mixed episodes
1.5. Course of illness and prognosis
1.6. Overview of available interventions
1.7. Treatment 1: mood stabilisers
1.8. Treatment 2: antimanic drugs
1.9. Treatment 3: antidepressants
1.10. Pregnancy, genetic counselling and effects on families
1.11. Risks associated with treatment withdrawal
1.12. Alcohol, smoking, diet and street drugs
1.13. Early detection of mania and hypomania 1
1.14. Early detection of mania and hypomania 2
1.15. Early detection of depression and mixed episodes 1
1.16. Early detection of depression and mixed episodes 2
1.17. What to do when a new phase is detected
1.18. Regularity of habits
1.19. Stress control techniques
1.20. Problem solving strategies
1.21. Finalising a care plan and course

The group will be a closed one, ideally starting with 17 - 18 participants. In practice 25% of patients will not attend so that the average group size will be 12 - 14 participants. Any participant who misses a session will be provided printed materials for the session and an opportunity to discuss the materials before the next session. However, absence of five consecutive sessions will be considered a drop-out from treatment and these participants will be excluded from further groups. They will be offered a complete set of handouts for all group sessions. The work in the psychoeducation group builds on earlier sessions so the involvement of participants who had not attended earlier sessions would be disruptive to the other participants in the group. The same rule will apply to the bipolar group support arm so that there is internal consistency within the RCT and the RCT remains internally valid.

A manual will be produced for the therapists. The content and conduct of each session will be recorded on written forms by the therapists and participants (with the therapists not present) using the treatment fidelity checklist. Participants will also be asked for consent to audio-tape the group. If all consent, this will be used to assess fidelity. If one or more participants do not wish to be recorded only the fidelity checklist will be used for that group. Where groups are recorded and checklist used, this data will be used to evaluate the validity of the checklist as a proxy measure of fidelity.

As part of the group, participants will produce a care plan. This will include a list of people this can be shared with including family members and clinicians. A final version will be signed by the participants and therapists and sent to relevant members of the clinical team to aid communication. Patients will receive in addition their usual treatment which will be unconstrained and recorded from case notes and at the CSRI interview.

2. Bipolar Group Support Intervention:
Meeting other service users with bipolar disorder and discussing collective experience can be a powerful form of support and information giving in its own right. To ensure that the content of the group psychoeducation programme is effective, we need to control for the effects of meeting together. Therefore, two health professionals and an expert patient (the same people conducting the psychoeducation group), will meet in groups of 18 participants. In practice due to attrition the group will be around 12 - 14 participants. The group will have 21 weekly sessions running from 90 minutes.

In this group the topics for discussion will be entirely determined and led by the service users in the group. The health professionals and expert patient will be more passive, being there to facilitate discussion, encourage participation and prevent unhelpful group behaviour such as bullying or scapegoating. They will be instructed not to provide information on bipolar disorder. To limit this possibility, the content and conduct of each session will be recorded by each therapist and each participant (with the therapist not present) as a quality check and to record how the bipolar support group different in form and content form the bipolar psychoeducation group. A manual on the conduct of the bipolar support group will be produced for the therapists. Patients will receive in addition their usual treatment which will be unconstrained and recorded from case notes and at the CSRI interview.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Time to next bipolar episode and average weekly symptom score, both established using four monthly SCID LIFE interviews to generate weekly scores of mania and depression on 1 - 6 scale of severity
2. Primary economic measure of incremental cost per quality adjusted life year gained

Follow-up of each patient will be for 24 months from randomisation. Patients who had not relapsed at 24 months will be censored on the time to next episode outcome. The peak effect of psychoeducation on time to next bipolar episode have been observed at 24 months after randomisation. Baseline interview using the SCID will assess the presence of axis 1 and axis 2 comorbid psychopathology and the number of previous bipolar episodes.

Secondary outcome measures

1. Assessment of weekly symptoms using the LIFE
2. Assessment of function using the Social Adjustment Scale, and Social and Occupational Functioning Assessment Scale (SOFAS)
3. Observer and self-rated measures of mood: 17-item Hamilton Depression Scale (HDRS), Bech-Raphaelson Mania Scale (MAS), Beck Depression Inventory (BDI) and PHQ-9 (Personal Health Questionnaire)
4. Medication adherence

Schedule of assessment:
At baseline, 12 and 24 months (face to face assessments): SAS, Economic Interview (CSRI), EuroQol
At 4, 8, 16, and 20 months (telephone assessments): LIFE, HDRS, MAS, SOFAS, MedAd, BDI version 1(by post), PHQ-9 (by post)

Overall trial start date

01/03/2009

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID-DSM-IV) verified diagnosis of primary bipolar disorder
2. Increased risk of relapse (at least one episode in the last 24 months)
3. Age over 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 groups of 18 subjects in each arm, 179 per arm, 358 in total

Participant exclusion criteria

1. Presence of a current manic, hypomanic, mixed affective or major depressive episode currently or within the previous 8 weeks
2. Current suicide plans or high suicide intent
3. Inability or unwillingness to give written informed consent to the study
4. Participants would have to be able to communicate in written and verbal English to a sufficient level to allow them to complete the measures and take part in the groups

Recruitment start date

01/03/2009

Recruitment end date

01/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG7 2TU
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innnovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-10389)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21777426
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27688021

Publication citations

  1. Protocol

    Morriss RK, Lobban F, Jones S, Riste L, Peters S, Roberts C, Davies L, Mayes D, Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder., BMC Psychiatry, 2011, 11, 114, doi: 10.1186/1471-244X-11-114.

Additional files

Editorial Notes

03/10/2016: Publication reference added.