Evaluating the feasibility and acceptability of a time limited anxiety in bipolar disorder

ISRCTN ISRCTN84288072
DOI https://doi.org/10.1186/ISRCTN84288072
Secondary identifying numbers 9419
Submission date
28/03/2011
Registration date
28/03/2011
Last edited
13/03/2020
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

Not provided at time of registration

Contact information

Prof Steve Jones
Scientific

Spectrum Centre for Mental Health Research
School of Health and Medicine
Lancaster University
Lancaster
LA1 4YT
United Kingdom

+44 (0)1524 593 382
s.jones7@lancaster.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial evaluating the feasibility and acceptability of a time limited anxiety intervention in bipolar disorder
Study objectivesThis study aims to evaluate the feasibility and acceptability of a newly adapted, time limited, psychological intervention for anxiety and bipolar disorder. The intervention has been developed in collaboration with service users and health professionals in earlier phases of this research and is based on current, evidence based cognitive behavioural therapy interventions for anxiety and bipolar disorder.

The principle objectives of this study are to evaluate the feasibility of recruiting participants into this study and of delivering this intervention to individuals who experience anxiety and bipolar disorder. The acceptability of the intervention to those who receive it will also be evaluated.

A secondary objective is to assess if the intervention is likely to be clinically effective in reducing anxiety and mood symptoms for individuals with bipolar disorder and concurrent anxiety. These objectives will be evaluated by monitoring recruitment and retention into the study, eliciting feedback from participants in the treatment arm of the trial, and measuring anxiety and mood symptoms at baseline and follow-up time points to evaluate if the intervention is likely to be effective at reducing mood and anxiety symptoms.

Please note that as of 13/11/2012, the anticipated end date of this trial was updated from 30/04/2011 to 24/01/2014.
Ethics approval(s)North West Lancaster Research Ethics Committee ref:10/H1015/83 06/12/2010, amended 21/01/2011
Health condition(s) or problem(s) studiedBipolar disorder
Intervention1. PARADES Anxiety, A psychological intervention for the joint treatment of anxiety and bipolar disorder
2. Follow Up Length: 20 month(s); Study Entry : Single Randomisation only
3. Participants who take part in this study will be randomly allocated to receive either the intervention, or their usual treatment.
4. Those in the intervention arm of the study will receive a maximum of 10 therapy sessions over a 4 month period, delivered by a trained psychological therapist, either at home or another place they feel comfortable.
5. All participants who take part in the study will be followed up both in person and over the telephone at regular 4 monthly intervals, over a period of 20 months and all participants will have the chance to share their personal experiences with the research team.
Intervention typeOther
Primary outcome measureRecruitment & Retention: Timepoint(s): Baseline, 4, 8, 12, 16 and 20 months
Secondary outcome measuresAnxiety symptoms; Timepoint(s): Baseline, 4, 8, 12 16 and 20 months; Mood symptoms; Timepoint(s): Baseline, 4, 8, 12, 16 and 20 months.
Overall study start date05/01/2011
Completion date24/01/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 72; UK Sample Size: 72
Key inclusion criteria1. Primary diagnosis of bipolar I or II disorder
2. Current experience of anxiety evidenced by a HADS-A score > 8
3. Aged 18+
4. Ability to understand spoken and written English to a level where participants are able to provide written informed consent and are able to participate in interviews, questionnaires and therapy sessions, where appropriate.
5. Male or Female
Key exclusion criteria1. Current experience of a manic, hypomanic, depressed or mixed episode, or experience of this in the past four weeks, although it is expected that some subsyndromal symptoms will be present
2. Current suicidal ideation with intent
Date of first enrolment05/01/2011
Date of final enrolment24/01/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Lancaster University (UK)
University/education

Physics Department
Lancaster University
Bailrigg
Lancaster
LA1 4YW
England
United Kingdom

ROR logo https://ror.org/04f2nsd36

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Programme for Applied Research

No information available

Ref: RP-PG-0407-10389

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/02/2013 Yes No

Editorial Notes

13/03/2020: Internal review.

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