Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
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2018
INTERVENTION: The randomisation sequence will be generated using computer software, RedCap (i.e., an online central randomisation service provided by Bristol Medical School). Randomisation will be stratified by site and blocked, and participants will be randomised using a 1:1 algorithm to ensure an equal number of participants in the treatment and control arms. Allocation concealment will be ensured as the randomisation code will not be released until the IAPT client has been recruited into the trial, which takes place after participant eligibility has been assessed, participant identifier has been recorded and consent gained to take part in the trial and to being randomly allocated to treatment condition. Randomisation will be requested via RedCap by the researcher who recruited and consented the participant into the trial. RedCap will send a response to the researcher informing them which treatment the participant will be receiving. Randomisation can only be requested once and after participant identifier, eligibility and consent has been recorded, and therefore implementation cannot be influenced by the PWP, participant, the research or clinical team. Both treatments are very similar and involve behavioural, psychological support and medicine to help participants to quit. The difference between the treatments is that one will be delivered alongside psychology therapy, and the other treatment will involve being referred to the local stop smoking service at the end of the IAPT therapy. Participants assigned to receive the smoking treatment alongside their psychology therapy will talk to their Psychological Wellbeing Practitioner about their smoking for up to 15 minutes during each therapy appointment. They will be guided through behavioural techniques to support them through the quit attempt. The Psychological Wellbeing Practitioner will also talk about the psychology of quitting, and how quitting might improve mental health. In addition, participants receive a smoking cess CONDITION: Tobacco addiction (smoking) ; Mental and Behavioural Disorders ; Mental and behavioural disorders due to use of tobacco PRIMARY OUTCOME: Retention in the smoking cessation treatment, measured at treatment appointments 1 to 6 INCLUSION CRITERIA: 1. Aged 18 years or older 2. Has current diagnosis of depression (clinician administered PHQ‐9 score of = 10) and/or anxiety (clinician administered GAD‐7 score of =8) (note: other mental health comorbidities are allowable) 3. Self‐reported, daily tobacco smoker of at least 1 year 4. Interested in receiving help to quit smoking tobacco 5. Eligible for IAPT treatment on a one‐to‐one basis over the telephone or face‐to‐face 6. About to start psychological therapy for depression/anxiety in IAPT SECONDARY OUTCOME: Smoking‐related:; 1. Biochemically‐verified 7‐day point prevalence smoking cessation at 3 months after baseline; 2. Number of cigarettes smoked per day, measured at enrolment, treatment appointments 1 to 6 and 3 months after baseline; 3. Heaviness of Smoking Index, measured at enrolment, treatment appointments 1 to 6 and 3 months after baseline; ; Mental health‐related:; 1. Symptoms of depression, measured using PHQ‐9; 2. Symptoms of anxiety, measured using GAD‐7; ; Service‐related:; Number of “Did Not Attends”, number of planned and completed IAPT sessions, measured at treatment appointments 1 to 6; ; Acceptability and feasibility; Participant and clinician acceptability and satisfaction of intervention as assessed by questionnaires and qualitative interviews, interviews also explore acceptability and feasibility of data collection procedures, and impact of smoking cessation treatment on usual care and psychological recovery. Assessed at 3 months after baseline ; ; Implementation‐related; intervention delivery checklist, qualitative analysis of intervention delivery, measured at treatment appointments 1 to 6
Epistemonikos ID: 32786dcbbb99187794bccbd7f66193e58cc4d120
First added on: Aug 24, 2024