ISRCTN ISRCTN75675072
DOI https://doi.org/10.1186/ISRCTN75675072
Secondary identifying numbers v2: 11.01.08
Submission date
06/02/2012
Registration date
17/02/2012
Last edited
02/10/2017
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
Low self-esteem (LSE) has been shown to be both a consequence and a cause of psychiatric problems and is distressing and debilitating in its own right. As such, it is a frequent target for treatment in cognitive-behavioural interventions, yet it has rarely been the main focus of therapy. A cognitive-behavioural treatment (CBT) programme for LSE has been developed. CBT is a talking therapy that can help you manage your problems by changing the way you think and behave. While case studies suggest that this treatment approach may be an effective way to treat LSE, it has not yet been systematically evaluated. This study aimed to compare how well 10 sessions of individual CBT with workbooks for LSE works in patients with a full range of psychiatric diagnoses. The impact of CBT was measured using measures of self esteem, depression, anxiety and general functioning, as well as psychiatric diagnoses. The study also aimed to find out whether any treatment gains were maintained at a 10-week follow-up assessment.

Who can participate?
Patients aged 18 or older with LSE

What does the study involve?
Participants are randomly allocated to either begin treatment immediately or after a 10-week delay. All participants receive 10 sessions of CBT, taking place over 10 weeks. The appointments each last around 50 minutes and take place at the University of Reading Medical Practice. The first four sessions are twice weekly, the following four sessions are weekly and the final two sessions are fortnightly. Treatment involves trying to make sense of participants’ LSE and identifying and modifying the beliefs and behaviours keeping it going. They work together with the therapist as a team and a crucial part of treatment is carrying out tasks between sessions, such as keeping a diary or experimenting with doing things differently. In order to monitor progress, they are asked to fill in some questionnaires at the beginning of each session. During the research they are asked not to change any medication that they are taking. Sessions are taped to ensure that the treatment was the best possible and participants get a copy to ensure that they get the most out of treatment.

What are the possible benefits and risks of participating?
The study involves treatment for LSE. While treatment sessions may involve discussing potentially upsetting situations, sessions are carried out with a qualified clinical psychologist. A possible burden might be the time required to carry out the assessments and post-treatment and follow-up assessments. However, efforts are made to accommodate participants’ schedules and set up appointments at times that are most convenient for them.

Where is the study run from?
University of Reading Medical Practice (UK)

When is study starting and how long is it expected to run for?
March 2008 to December 2008

Who is funding the study?
British Association for Behavioural and Cognitive Psychotherapies (UK)

Who is the main contact?
Dr Polly Waite
p.l.waite@reading.ac.uk

Contact information

Dr Polly Waite
Scientific

University of Reading
Department of Psychology & Clinical Language Sciences
Whiteknights Road
Reading
RG6 6AL
United Kingdom

Phone +44 (0)118 378 5534
Email p.l.waite@reading.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 to request a participant information sheet
Scientific titleCognitive behaviour therapy for low self-esteem: a preliminary randomized controlled trial in a primary care setting
Study objectives1. Compared to waitlist, cognitive behaviour therapy (CBT) for low self-esteem (LSE) will lead to greater improvements in self-esteem, anxiety, depression, and general functioning and a greater reduction in psychiatric diagnoses
2. Any treatment gains from CBT for LSE will be maintained at a follow-up assessment
Ethics approval(s)Berkshire Research Ethics Committee, February 2008, ref: 07/H0505/196
Health condition(s) or problem(s) studiedLow self-esteem
Intervention1. Immediate treatment: 10 sessions of CBT delivered one-to-one, with accompanying workbooks
2. Ten week waitlist followed by above treatment
Intervention typeOther
Primary outcome measureThe Robson Self-Concept Questionnaire (RSCQ; Robson, 1989)
Secondary outcome measures1. The Structured Clinical Interview for DSM-IV Disorders (SCID-I-RV; First, Spitzer, Gibbon & Williams, 2002)
2. The Beck Depression Inventory-II (BDI-II; Beck, Steer & Brown, 1996)
3. The Beck Anxiety Inventory (BAI; Beck & Steer, 1990)
4. The Clinical Outcomes in Routine Evaluation ¨C Outcome Measure (CORE-OM; Evans, Connell, Barkham, Margison & McGrath, 2002)
Overall study start date05/03/2008
Completion date31/07/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteria1. Clinically significant low self-esteem as evidenced by:
1.1. A score of more than one standard deviation below the mean on the Robson Self-Concept Questionnaire (RSCQ) (Robson, 1989)
1.2. Psychological difficulties that interfered with functioning as evidenced by scoring outside the 'healthy' range on the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) (Evans, Connell, Barkham, Margison & McGrath, 2002)
2. If taking medication, this needs to be at a stable dosage for the preceding 6 weeks before being assessed for the trial
Key exclusion criteria1. Having been diagnosed with a psychotic illness
2. If severity of symptoms or suicidality meant that allocation to a delayed treatment condition would be unethical
Date of first enrolment05/03/2008
Date of final enrolment01/12/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Reading
Reading
RG6 6AL
United Kingdom

Sponsor information

University of Reading (UK)
University/education

c/o Dr Mike Proven
Research & Enterprise Services
Reading
RG6 6AL
England
United Kingdom

Website http://www.reading.ac.uk/qar/index.htm
ROR logo "ROR" https://ror.org/05v62cm79

Funders

Funder type

Research organisation

British Association for Behavioural & Cognitive Psychotherapies [BABCP] (UK)

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 01/12/2012 Yes No

Editorial Notes

02/10/2017: Publication reference added.