None listed
Conditions
Brief summary
This pilot randomized controlled trial (RCT) aims to examine the feasibility, efficacy, and cost-effectiveness of a new risk-targeted transdiagnostic CBT telehealth program (FullFix) for comorbid alcohol and other drugs (AOD) and mental health problems in young people. The study aims to recruit 130 participants aged 16 - 25, who will be randomised to receive 4 core modules (and up to 4 additional modules) targeting transdiagnostic risk and protective factors for mental health and AOD use, or usual AOD care. Participants' AOD use, mental health, and functional outcomes will be assessed at baseline, and at 1 month, 2, 6, and 12 months post baseline.
Interventions
The intervention will be the FullFix telehealth treatment. The FullFix telehealth treatment consists of four core sessions and four additional optional sessions tailored to the individual’s specific risk and protective factor profile using a case-formulation approach. The modules are delivered individually in 20-40 min telephone therapy calls for up to 8 weekly or fortnightly sessions. Sessions may be broken into two shorter calls per week if the participant prefers. As it is a telephone intervention, the location of the intervention will vary. The clinician will ensure the participant is in a safe and private location during the sessions. The clinician will be delivering the intervention from their office. The intervention will be delivered by trained research psychologists, general registered psychologists, provisional psychologists, or trained LLW clinicians. Core Modules: In Session 1, participants are provided with motivational enhancement training and are provided with personalised assessment feedback and psychoeducation about their alcohol and other drug use and related problems, depression and anxiety symptoms, emotion regulation difficulties, and coping styles (e.g. avoidance, aggression, risky behaviors). A preliminary case formulation is developed and treatment goals are identified. Participants also receive psychoeducation around harm minimisation strategies for alcohol and other drug use, and develop a harm minimisation implementation intention plan. In Session 2, participants first review how the implementation of their harm minimisation plan went over the previous week. They are then assessment feedback on their personality risk profile including impulsivity and sensation seeking proneness, positive and negative urgency, and anxiety and depression proneness. This information is then incorporated into the participant’s case formulation and they are provided with cognitive behavioural coping skills training targeting their top 1-2 personality risk profiles. Those predominantly with high in anxiety proneness are trained in mindful breathing and thought awareness and acceptance for anxious thoughts. Individuals high in depression proneness receive behavioural activation and thought awareness and acceptance training for depressive thoughts. Those high in sensation seeking receive training in savouring techniques to increase their awareness and ability to focus on and experience positive feelings from everyday activity (e.g. mindful eating) and are encouraged to identify and schedule natural highs from functional activities (e.g. exercise, skateboarding, rock climbing) and daily experiences (food, sex, music). Participants with high levels of impulsivity receive mindfulness training to increase awareness of their thoughts and emotions, are encouraged to apply the Stop-Think-Do rubric to help them slow down their decision-making processes sufficiently to consider likely outcomes of behavioural alternatives. Participants with high levels of positive or negative urgency will receive training to recognising and learning to observe emotions emotional responses (positive and negative), sitting with emotional responses (positive and negative) combined with either impulsivity or sensation seeking training depending on their personality risk profile. At the end of the session participants develop a coping skills implementation intention plan. In Session 3, participants first review how the implementation of their coping skills plan went over the previous week. They then receive assessment feedback of their strengths, and identify which strengths they think they have, and what strengths they can draw on to help with their coping of skills identified in session 1 and 2. They are encouraged to incorporate their strengths into their coping skills plan at the end of their session. In Session 4, participants review their goals, coping skills, and strengths. The session content then focuses on how to generalise the participants coping plan using a 5-step self-regulation framework. The session will focus on 1) teaching participants to become more aware of their surroundings, internal and external state; 2) acknowledging (rather than avoiding) the present moment; 3) redirecting their attention and focus; 4) appraising the situation and their coping strategies; and 5) choosing and taking the best course of action. Additional Modules: Physical Self-regulation Session: This session will focus on awareness and understanding of psychophysiological responses, ways to regulate physiological responses, specifically through diaphragmatic breathing and relaxation, and longer-term strategies for self-care (sleep hygiene, healthy eating, and physical activity). Emotions Self-regulation Session: This session comprises of psychoeducation (what are emotions, function of emotions, thought-feeling-behaviour connection); recognising and learning to observe emotions/emotional responses (positive and negative), sitting with emotional responses (positive and negative); and emotion regulation strategies. Cognitive Self-regulation Session: This session extends on skills taught in Session 2 to address maladaptive coping strategies (suppression, rumination, avoidance); improve positive coping (appraisal, problem solving, and acceptance). Social Self-regulation Session, which focuses on gaining social support, making and keeping social connections and relationships, identifying barriers to social connectedness, and interpersonal skills training to help overcome barriers. If necessary, case-management will be provided by Lives Lived Well staff in addition to FullFix. Frequency, duration, modality (phone or face-to-face) and type of case-management will be recorded for each participant. To assess intervention adherence and fidelity, telephone treatment sessions will be audio-recorded, with the participant’s consent. Clinicians will also record a session component checklist for each session completed. Supervision meetings will be held fortnightly to monitor session delivery and treatment adherence. Additionally, the supervisor will review a randomly selected session audio segment, independently rating it and a Session Component Checklist, and discuss any departures from protocol. A random sample (20%) of session recordings will be independently rated for treatment fidelity to ensure core features of the allocated treatment are delivered.
Sponsors
Study design
Eligibility
Inclusion criteria
- Aged 16-25 years; - Participants seeking help for their AOD use from participating Lives Lived Well Services; - Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): above moderate severity for alcohol use or illicit drug use, and screening measures score above moderate severity for depression (Patient Health Questionnaire – 9 [PHQ9]) or anxiety (Generalized Anxiety Disorder 7-item); - Access to phone technology.
Exclusion criteria
- Current serious medical problem or traumatic injury; - Not fluent in spoken or written English; - Unmodified hearing impairment; - Current high suicide risk (current intent and plan); - Current or history of psychosis in past 12 months; - History of traumatic brain injury or organic brain disease; - Currently in acute alcohol or drug withdrawal