A recovery focused cognitive-behavioural therapy for older adults with bipolar disorder

ISRCTN	ISRCTN13875321
DOI	https://doi.org/10.1186/ISRCTN13875321
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Lancaster University
Funder	National Institute for Mental Health Research

Submission date: 05/11/2015
Registration date: 12/11/2015
Last edited: 21/12/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Elizabeth Tyler
Public

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

Phone	+44 1524 593171
Email	e.tyler@lancaster.ac.uk

Study information

Primary study design	Interventional
Study design	Two-arm randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A feasibility randomised controlled trial of recovery focused cognitive-behavioural therapy for older adults with bipolar disorder
Study acronym	Rf-CBT-OA
Study objectives	Recovery focused CBT will be feasible and acceptable for older adults with bipolar disorder.
Ethics approval(s)	UK NHS Ethics Committee, 22/05/2015, ref: 15/NW/0330
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/08/2020

Eligibility

Participant type(s)	Patient
Age group	Senior
Lower age limit	60 Years
Sex	All
Target sample size at registration	50
Total final enrolment	39
Key inclusion criteria	1. Aged 60 years 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
Key exclusion criteria	1. Receiving concurrent psychological therapy 2. A score of less than 22 on the Montreal Cognitive Assessment (MoCA: Nasreddine et al, 2005)
Date of first enrolment	01/01/2017
Date of final enrolment	01/07/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Spectrum Centre for Mental Health Research

Lancaster University
Bailrigg
Lancaster
LA1 4YT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		24/10/2022	21/12/2023	Yes	No
Protocol article	protocol	03/03/2016		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Developing a recovery-focused therapy for older people with bipolar disorder: a qualitative focus group study	04/08/2021	28/10/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/12/2023: Publication reference added.
28/10/2022: Publication reference added.
15/01/2020: The following changes have been made:
1. The intention to publish date has been changed from 31/12/2018 to 31/12/2020.
2. The overall trial end date has been changed from 01/01/2019 to 31/08/2020.
3. The total final enrolment number has been added.
07/03/2016: Publication reference added.