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A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates

Integrating Health Psychology Into Hepatitis c Treatment: a Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03293576
Acronym
ADAPT
Enrollment
52
Registered
2017-09-26
Start date
2018-02-22
Completion date
2020-01-03
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Behavioural Medicine, Health Psychology, Psychosocial Intervention, People Who Inject Drugs

Brief summary

The study evaluates the use of implementation intentions to increase self-efficacy and reduce injecting risk behaviour in a sample of injecting drug users on treatment for hepatitis C (HCV). The overall aim is to reduce HCV reinfection rates. The primary objective is to identify lower injecting risk behaviour scores in patients on treatment for hepatitis C receiving the psychosocial intervention compared to the same patient group assigned to the control group.

Detailed description

The intervention will entail completing a volitional help sheet.This will create implementation intentions, which are self-regulatory strategies taking the form of if-then plans (i.e. situation-solution plan). Injecting risk behaviour scores and self-efficacy scores will be analysed for differences between intervention and control groups. To control for contact-time with the researchers, participants in the control group will spend approximately 20 minutes with the researcher exploring Zimbardo's time perspective constructs (ZTPI, Zimbardo & Boyd, 1999) and completing the short Zimbardo's time perspective inventory (Orosz et al. 2017). The inventory was selected because the cognitive processes involved in accessing time constructs will also be activated in the intervention group for the planning of coping strategies and goal achievement during future injecting risk situations. The study also aims: * To assess the variability in injecting risk behaviour as explained by subjective norms, social connectedness and group identification constructs; * To assess the variability in intervention effectiveness as explained by changes in mental health, illness perception subjective norms, social connectedness, and group identification.

Interventions

This brief intervention will last around 20 minutes. The participants and the researcher will read through the list of real-life solutions the participants might find applicable to them. They will then read through the list of situations one by one. The participant will draw a coloured line between the situation and the solution which seems more appropriate to them. The volitional help sheet helps create implementation intentions, which are self-regulatory strategies taking the form of if-then plans (i.e. situation-solution plan).

Sponsors

NHS Tayside
CollaboratorOTHER_GOV
University of Dundee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or Female. (Over 18 years of age); * Chronic HCV positive infection; * Current illicit drug use established through participants' self-report; * Current HCV treatment provided by the NHS; * Informed consent, agreeing to study and monitoring criteria; * English-speaking.

Exclusion criteria

* Inability to provide informed consent; * Aggressive or violent behaviour; * Not currently receiving HCV treatment; * Inability to communicate in English.

Design outcomes

Primary

MeasureTime frameDescription
Injecting Risk Behaviour4 weeksSelf-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)
Self-Efficacy4 weeksSelf-reported confidence in one's own ability to refuse sharing of injecting equipment and use of old injecting equipment. Fifteen items scored 1-7 (1 high confidence, 7 low confidence)

Secondary

MeasureTime frameDescription
Social ConnectednessUp to 8 weeksSelf-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness)
Group IdentificationUp to 8 weeksSelf-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification).
Depression2 weeksSelf-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
Post traumatic stress disorder1 monthSelf-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.
Working allianceTreatment duration (12 weeks)Self-reported therapeutic alliance with provider of hepatitis C treatment care over treatment duration. Eight items scored 1-5 (1 poor alliance, 5 excellent alliance).
Illness perceptionUp to 8 weeksSelf-reported perception of hepatitis C as an illness. Eight items scored 1-10 (1 no impact on quality of life, 10 high impact on quality of life).
Anxiety2 weeksSelf-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
Subjective NormsUp to 4 weeksSelf-reported social norms of individual's injecting network. Four items scored 1-7 (1 strong acceptance of sharing equipment, 7 no acceptance of sharing equipment).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026