Condition category
Mental and Behavioural Disorders
Date applied
05/11/2015
Date assigned
12/11/2015
Last edited
07/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Bipolar disorder, previously known as “manic depression”, is a serious mental illness that is characterised by severe episodes of depression (extreme lows) and mania (extreme highs) or hypomania (a milder form of mania). There are a number of different types of bipolar disorder, as the symptoms vary greatly between different people. Two of the most common types are known as bipolar I and II. Bipolar I is characterised by severe manic episodes, and bipolar II is characterised by severe depression alternating with episodes of hypomania. Bipolar disorder is typically diagnosed in adolescents, but it can affect people of any age. Bipolar disorder continues into older adulthood and the number of people over the age of 60 with this condition is set to rise as the population is aging. It has also been noted that the disorder can be more severe in older adults, with a higher suicide rate than in other mental illnesses in the same age group. Cognitive behavioural therapy (CBT) is a talking therapy which teaches people ways to deal with their problems by changing the way they think and behave. Many studies have shown that CBT can be an extremely effective therapy for bipolar disorder in younger patients and further research is needed to find out if it is an effective treatment in older adults. A new recovery focused CBT technique (which is geared towards improving personal recovery) has been developed for use in older adults (RfCBT-OA). The aim of this study is to find out whether this is an effective treatment for older adults who experience bipolar disorder.

Who can participate?
Adults aged 60 or over with bipolar disorder I or II.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive treatment as usual (TAU) for the length of the study. Those in the second group attend up to 14 sessions of recovery-focussed CBT for older adults (rfCBT-OA) over 6 months, alongside their TAU. At the start of the study and then every 3 months for a total of 12 months, participants complete a number of questionnaires to find out if there has been any change in their condition. The amount of participants who are recruited and any who drop out of the study are also recorded in order to find out whether a larger study testing the effects of rfCBT-OA would work.

What are the possible benefits and risks of participating?
Participants in the CBT group benefit from therapy sessions that they would be unlikely to get access to otherwise. There are no notable risks of taking part in this study.

Where is the study run from?
Spectrum Centre for Mental Health Research (UK)

When is the study starting and how long is it expected to run for?
March 2015 to January 2019

Who is funding the study?
National Institute for Mental Health Research (UK)

Who is the main contact?
Dr Elizabeth Tyler
e.tyler@lancaster.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Elizabeth Tyler

ORCID ID

Contact details

Spectrum Centre for Mental Health Research
Lancaster University
Lancaster
LA1 4YW
United Kingdom
+44 1524 593171
e.tyler@lancaster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A feasibility randomised controlled trial of recovery focused cognitive-behavioural therapy for older adults with bipolar disorder

Acronym

Rf-CBT-OA

Study hypothesis

Recovery focused CBT will be feasible and acceptable for older adults with bipolar disorder.

Ethics approval

UK NHS Ethics Committee, 22/05/2015, ref: 15/NW/0330

Study design

Two-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Bipolar Disorder

Intervention

A parallel two-arm randomised controlled trial (RCT) a recovery focused CBT intervention alongside treatment as usual (TAU) versus TAU alone. Participant's will be randomly allocated to either RfCBT-OA or TAU using an independent web-based computer generated randomised procedure to aid allocation concealment. The randomisation process will be set up by Lancashire Clinical Trials Unit (CTU).

RfCBT-OA arm: Participants in the recovery focused CBT arm will receive up to 14 sessions of therapy over a 6 months time period, alongside their TAU.

TAU arm: Participants in the TAU arm will continue their usual treatment plan which typically involves seeing a healthcare professional such as a GP, Psychiatrist or Community Mental Health Nurse.

Participants in both arms of the study will be followed up and complete assessments which will include a range of important clinical outcomes (e.g. recovery, time to relapse, quality of life) at baseline and then three monthly over the 12 month follow-up period.

Intervention type

Other

Phase

Drug names

Primary outcome measures

A number of outcomes in relation to measuring the feasibility and acceptability of delivering recovery focused CBT to older adults with bipolar disorder:
1. The recruitment rate is assessed by measuring the number of eligible participants recruited by self-referral and from each of the NHS sites on a monthly basis. The total will be recorded at the end of the 15 month recruitment window.
2. Consent rate and reasons for non-recruitment is documented on a continuous basis. The total will be recorded at the end of the 15 month recruitment window.
3. The number of participants lost to follow-up and the reasons for loss to follow-up during the 12 month follow-up period will be recorded, plus reasons for loss (if given) on a continuous basis
4. The number of therapy sessions attended will be documented out of 14 at the end of the study period
5. The number of participants who drop out of therapy is documented on a continuous basis throughout the study period

Secondary outcome measures

The secondary outcome of the study is to gain an estimate of the likely effect size of recovery focused CBT on a range of clinical outcomes:
1. Time to relapse will be measured by the Structured Clinical Interview for Diagnosis: Research Version (SCID-LIFE) at 3 months, 6 months, 9 months and 12 months
2. Functioning will be measured by the Personal & Social Performance Scale (PSP) at baseline, 3 months, 6 months, 9 months and 12 months
3. Personal recovery will be measured by the Bipolar Recovery Questionnaire (BRQ) at baseline, 6 months and 12 months
4. Bipolar symptomatology will be measured by the Internal State Scale (ISS) at baseline, 6 months and 12 months
5. Depression symptoms will be measured by the Centre for Epidemiologic Studies Depression Scale (CES-D) at baseline, 6 months and 12 months
6. Functioning will be measured by the Work & Social Adjustment Scale (WSAS) at baseline, 6 months and 12 months
7. Quality of life with be measured by the World Health Organisation Quality of Life scale (WHOQOL-Bref) at baseline, 6 months, 12 months
8. Quality of life will be measured by the Quality Of Life in Bipolar Disorder scale (QoL.BD) at baseline, 6 months and 12 months

Overall trial start date

01/03/2015

Overall trial end date

01/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 or above
2. A diagnosis of BD (I or II) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM; First et al, 2004) IV research criteria
3. Not in a current episode of mania, hypomania, depression or mixed episode in the last month
4. Sufficient English language skills to comprehend the assessments and intervention content

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Receiving concurrent psychological therapy
2. A score of less than 22 on the Montreal Cognitive Assessment (MoCA: Nasreddine et al, 2005)

Recruitment start date

01/01/2017

Recruitment end date

01/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Spectrum Centre for Mental Health Research
Lancaster University Bailrigg
Lancaster
LA1 4YT
United Kingdom

Sponsor information

Organisation

Lancaster University

Sponsor details

Bailrigg
Lancaster
LA1 4YT
United Kingdom

Sponsor type

University/education

Website

http://www.lancs.ac.uk/

Funders

Funder type

Research organisation

Funder name

National Institute for Mental Health Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Articles will be submitted for publication in high impact peer-reviewed journals with an emphasis on BD and psychological interventions (the protocol paper for the trial will be submitted in November 2015, the main trial paper will be published in 2018 once data collection and analysis is complete).
2. Presentations at national and international conferences relating to clinical psychology, mood disorders, and psychological interventions e.g., the annual conference of the BABCP, the Association for Behavioural and Cognitive Therapies, and the annual BABCP Bipolar Disorder Special Interest Group conference (delegates include service users, their families, mental health professionals, and academics) and the annual ABCT conference in America.
3. The Service User Representative for the project will advise on strategies for communicating information effectively to non-academic audiences. Articles for service user journals / resources / websites will be produced (e.g. MIND, RETHINK, Bipolar UK Organisation, Age UK and Service Users in Research (MHRN), who publish newsletters and hold Patient and Public Involvement events).
4. A written report will be produced and distributed across NHS Trusts’: Presentations of findings will be made to local and participating NHS trusts.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26940112

Publication citations

Additional files

Editorial Notes

07/03/2016: Publication reference added.