Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
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

Dr Morris Nitsun

ORCID ID

Contact details

Redbridge Healthcare NHS Trust-
Goodmayes Hospital
Barley Lane
Ilford
IG3 8XJ
United Kingdom
+44 (0)20 8970 8434

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00954

Study information

Scientific title

Acronym

Study hypothesis

A pilot study has shown that women with mental health problems linked to a history of child sexual abuse improve significantly following brief, focal group psychotherapy (12 weeks). The proposed study investigates whether the improvement is sustained over a longer period and how the group intervention compares with both brief, focal individual therapy (12 sessions), and a no-treatment condition for women on a waiting list. Since group therapy is generally assumed to be less costly in NHS resources than individual therapy, because approximately 8 patients are seen in a more or less equivalent time to that of individual therapy, the outcome of the study has an important bearing on cost-effective service delivery. Three similar NHS sites/services are included in the study in order to maximise patient numbers and to provide experimental control of significant extraneous variables. Participants will be systematically assessed using standardised psychological questionnaires, and self-rating scales at regular periods and after treatment. Costs of input and ongoing service use will be compared in order to assess cost benefits.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and behavioural disorders: Other mental disorder

Intervention

1. Focal group psychotherapy (12 weeks)
2. Brief, focal individual therapy (12 sessions)
3. No-treatment condition for women on a waiting list

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The research aims to establish two results: whether treatment of some kind offers significant long term benefits over no treatment at all; and whether group treatment offers significantly better long term results that individual therapy. Whatever the nature of results obtained, they will contribute to a small but growing body of knowledge which will allow clinicians to make more empirically based treatment choices for the individual patient.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/05/1998

Overall trial end date

05/05/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Women survivors of childhood sexual abuse (CSA), aged 18-65 referred as out-patients to the Psychology Departments at Redbridge, Waltham Forest Health Care Trusts or Essex & Herts Community NHS Trust. Criteria for inclusion are that women present to the psychology departments with psychological difficulties in their current lives which they themselves link to their experiences of CSA, and express a desire to work primarily on CSA related difficulties.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

05/05/1998

Recruitment end date

05/05/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Redbridge Healthcare NHS Trust-
Ilford
IG3 8XJ
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16354439

Publication citations

  1. Results

    Ryan M, Nitsun M, Gilbert L, Mason H, A prospective study of the effectiveness of group and individual psychotherapy for women CSA survivors., Psychol Psychother, 2005, 78, Pt 4, 465-479, doi: 10.1348/147608305X42226.

Additional files

Editorial Notes