Condition category
Mental and Behavioural Disorders
Date applied
28/03/2011
Date assigned
28/03/2011
Last edited
22/02/2013
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 Steve Jones

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9419

Study information

Scientific title

A randomised controlled trial evaluating the feasibility and acceptability of a time limited anxiety intervention in bipolar disorder

Acronym

Study hypothesis

This 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

North West Lancaster Research Ethics Committee ref:10/H1015/83 06/12/2010, amended 21/01/2011

Study design

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

1.Mental Health Research Network
2.Bipolar affective disorder
3.Disease: Bipolar affective disorder

Intervention

1. 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Recruitment & Retention: Timepoint(s): Baseline, 4, 8, 12, 16 and 20 months

Secondary outcome measures

Anxiety symptoms; Timepoint(s): Baseline, 4, 8, 12 16 and 20 months; Mood symptoms; Timepoint(s): Baseline, 4, 8, 12, 16 and 20 months.

Overall trial start date

05/01/2011

Overall trial end date

24/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 72; UK Sample Size: 72

Participant exclusion criteria

1. 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

Recruitment start date

05/01/2011

Recruitment end date

24/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Lancaster University (UK)

Sponsor details

Physics Department
Lancaster University
Bailrigg
Lancaster
LA1 4YW
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23414176

Publication citations

  1. Results

    Jones S, McGrath E, Hampshire K, Owen R, Riste L, Roberts C, Davies L, Mayes D, A randomised controlled trial of time limited CBT informed psychological therapy for anxiety in bipolar disorder., BMC Psychiatry, 2013, 13, 54, doi: 10.1186/1471-244X-13-54.

Additional files

Editorial Notes