Condition category
Mental and Behavioural Disorders
Date applied
06/02/2012
Date assigned
17/02/2012
Last edited
19/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

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

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

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

Who is funding the study?
The study was funded by the British Association for Behavioural and Cognitive Psychotherapies.

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Polly Waite

ORCID ID

Contact details

University of Reading
Department of Psychology & Clinical Language Sciences
Whiteknights Road
Reading
RG6 6AL
United Kingdom
+44 (0)118 378 5534
p.l.waite@reading.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v2: 11.01.08

Study information

Scientific title

Cognitive behaviour therapy for low self-esteem: a preliminary randomized controlled trial in a primary care setting

Acronym

Study hypothesis

1. 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

Berkshire Research Ethics Committee, February 2008, ref: 07/H0505/196

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 participant information sheet

Condition

Low self-esteem

Intervention

1. Immediate treatment: 10 sessions of CBT delivered one-to-one, with accompanying workbooks
2. Ten week waitlist followed by above treatment

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The Robson Self-Concept Questionnaire (RSCQ; Robson, 1989)

Secondary outcome measures

1. 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 trial start date

05/03/2008

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. 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

Recruitment start date

05/03/2008

Recruitment end date

01/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Reading
Reading
RG6 6AL
United Kingdom

Sponsor information

Organisation

University of Reading (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.reading.ac.uk/qar/index.htm

Funders

Funder type

Research organisation

Funder name

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

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

Publication citations

Additional files

Editorial Notes