A social network intervention for opiate users

ISRCTN	ISRCTN22608399
DOI	https://doi.org/10.1186/ISRCTN22608399
Protocol serial number	11845
Sponsor	Birmingham and Solihull Mental Health NHS Foundation Trust (UK)
Funder	Research for Patient Benefit Programme ref: PB-PG-0610-22392

Submission date: 27/04/2012
Registration date: 27/04/2012
Last edited: 31/01/2018

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

Ms Jennifer Seddon
Scientific

Research & Innovation
Birmingham and Solihull Mental Health NHS Foundation Trust
Radclyffe House
66-68 Hagley Road
Birmingham
B16 8PF
United Kingdom

Email	jennifer.seddon@bsmhft.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot study of a social network intervention for heroin users in routine NHS opiate substitution treatment
Study objectives	Hypotheses: 1. Social behaviour and network therapy (SBNT) is more effective than a case management intervention of similar intensity or treatment as usual in reducing illicit heroin use 3 and 12 months after treatment in clients receiving opiate substitution treatment for more than a year. 2. The formal null hypothesis is that there will be no difference in heroin use 3 and 12 months after treatment in opiate substitution clients receiving social behaviour and network therapy when compared with a case management intervention or treatment as usual. Social Behaviour and Network Therapy (SBNT) is an intervention developed in the UK by members of our research group. It integrates effective strategies from other treatment approaches and is built upon the premise that social network support for change is central to the resolution of addictive behaviour. As an intervention, SBNT has much potential but more research is needed to establish whether it is feasible to deliver SBNT in routine service provision and establish efficacy through a randomised controlled trial design. This is the overall long term aim for which this initial feasibility study will be conducted. Clients still using heroin in two NHS community drug treatment teams (Solihull & Leicester) will take part. Two clinicians per team will be trained in a 4-session manual-driven intervention (SBNT), and a further 2 in a 4-session case management intervention. Participants will be randomised to one of the two interventions or treatment as usual. Forty clients will be recruited to each of three arms, and interviewed at baseline and 3 and 12 months after the start of the intervention.
Ethics approval(s)	NRES Committee West Midlands - The Black Country, 08/03/2012, ref: 12/WM/0046
Health condition(s) or problem(s) studied	Addiction to illegal substance
Intervention	(i) Social Behaviour and Network Therapy (SBNT) Therapy will be delivered according to a purpose designed therapy manual. Clients randomised to SBNT will be offered 4 x weekly 50-minute SBNT sessions over a maximum of 6 weeks. All sessions will be video-recorded and reviewed by the research team to ensure fidelity with the SBNT manual and principles of practice. These procedures were developed and tested in UKATT, and further refined by our research group with drug treatment staff. The study manual will combine the most effective components of the SBNT intervention used in these earlier studies with elements of node-link mapping to facilitate the training and delivery of the intervention. The treatment will involve working with the client to draw a network diagram during the first session in order to identify potential social support for change that could be drawn upon during the treatment. Following this, potential supportive network members identified by the patient will be approached and invited to participate in treatment sessions in order to enhance the social support for change in drug use. The therapist will use elements of communication skill development, coping behaviours and the development of joint activities in order to support the process, with the ultimate aim of building a network-supported relapse management plan. (ii) Case Management This arm has been included in order to control for the intensity of treatment as well as the process and experience of receiving an intervention from a different therapist to the one delivering the routine care. This intervention will be close to usual key-working and will include a supportive interaction, reviewing current situation and goals, progress during the weeks between sessions and a discussion of any issues identified by the client. It will be manual-guided for standardisation. In common with the brief SBNT arm, clients will be expected to attend 4 weekly sessions over a maximum of 6 weeks (iii) Treatment as usual Clients in this arm will continue to receive usual care. Our research group conducted one of the few published studies describing treatment as usual in OST services in Birmingham. Meetings with clients occurred between weekly and fortnightly, and lasted an average of 45 minutes. Session activities fell into 4 broad categories, each delivered in similar amounts: case management, signposting of other services, structured psychosocial interventions, and other activities (e.g. medication issues). All clients will be assessed at baseline, as well as 3 and 12 months after the start of treatment. Family members of clients involved in the trial will also be assessed at baseline, 3 and 12 months.
Intervention type	Other
Primary outcome measure(s)	Heroin use measured at 3 and 12 months, measured using urinary drug analysis and self-report
Key secondary outcome measure(s)	1. Drug related problems measured at 3 and 12 months using the Maudsley Addiction Profile 2. Motivation to change measured at 3 and 12 months using the Readiness to Change Questionnaire - Treatment Version 3. Psychological symptoms measured at 3 and 12 months using the CORE-OM 4. Severity of dependence measured at 3 and 12 months using the Leeds Dependence Questionnaire 5. Social satisfaction measured at 3 and 12 months using the Social Satisfaction Questionnaire 6. Therapeutic engagement measured at 3 and 12 months using the Client Evaluation of Self and Treatment
Completion date	01/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Clients who have been receiving opioid substitution treatment (with either methadone or buprenorphine) continuously for more than a year but who still report heroin or other illicit opiate use in the preceding 28 days. 2. Adults (greater than 18 years old) with opioid dependence 3. Male and female participants 4. Aged 18 - 65 years
Key exclusion criteria	1. Patients with concurrent severe mental illness (e.g. schizophrenia, bipolar affective disorder, severe cognitive impairment) 2. Severe physical illness 3. Pending imprisonment
Date of first enrolment	01/06/2012
Date of final enrolment	01/01/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Birmingham and Solihull Mental Health NHS Foundation Trust

Birmingham
B16 8PF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2018		Yes	No
Protocol article	protocol	19/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/01/2018: Publication reference added.