None listed
Conditions
Brief summary
The SHADE study commenced in 2004 with the overall aim to evaluate the effectiveness of integrated, computer-delivered Cognitive Behaviour Therapy (CBT) for alcohol and other drug (AOD) problems among people with coexisting depression. Specifically, the project aimed to: * Trial CBT among people experiencing coexisting depression and AOD use problems employing either a psychologist or computer program to deliver the treatment; * Conduct the trial in both a rural and urban setting; * Assess the efficacy of the interventions relative to a non-specific treatment control group on measures of AOD use, service utilisation, symptomatology and functioning.
Interventions
Content of the interventions Both interventions have previously been developed and tested in a randomised controlled trial among the target population (see ACTRN12607000437460). In general, a harm minimisation approach to reducing depression and alcohol/other drug (AOD) use was emphasised during the treatment phase of the SHADE study. This is in line with recommendations from state health departments in Australia (e.g. NSWHealth, 2000) and evidence from the literature (e.g. Drake et al., 1998; Moggi et al., 2002). An integrated approach to treatment occurred, with the one clinician responsible for delivering treatment and co-ordinating care. Integration of strategies for depression and AOD use ensued, which allowed for recognition and exploration of the relationship between the depressive symptoms and substance use problem, including how each condition is exacerbated (Carroll, 2004). Motivational interviewing was used throughout the treatment program, as this set of techniques is considered central to integrated treatments (Mueser et al., 2003). Despite being developed for use in AOD use treatments, motivational interviewing is not limited to the AOD arena and can be used to help modify virtually any health-related behaviour, including mental health (Baker & Hambridge, 2002). Further, guidelines have also been provided for using motivational interviewing with people experiencing low mood (Rollnick, Mason, & Butler, 1999) as poor motivation and indecisiveness are commonly reported among people with depression. Thus, motivational interviewing is appropriate for depressed individuals experiencing ambivalence about the effort required to change, and the technique is suited to problem drinkers and drug users who are not contemplating change. SESSION 1 The initial session was delivered to all participants, prior to allocation to the treatment conditions in the study. Specifically, the session comprised case formulation, feedback from assessment and rapport building. A brief motivational interview was commenced, where the issues of AOD use were raised and expectancies for use discussed, and self-help material provided for both depression and AOD use problems. Case formulation strategies included the following components: developing a problem list, preliminary schema analysis, discussion of the origins of current problems (AOD use and depression), activating and precipitating situations, development of a treatment plan and setting goals for treatment. Session content was manualised and incorporated the approaches of Persons, Davidson and Tompkins (2001), Miller and Rollnick (1991), Rollnick, Mason and Butler (1999) and Beck, Rush, Shaw and Emery (1979). When describing the above skills and concepts, examples relating to both depressive and AOD use triggers were used. This session lasted around 60 minutes. At the conclusion of this session, the participant was provided with the randomisation envelope, which was opened and the resultant treatment allocation discussed. People allocated to receive further therapist- or computer-delivered SHADE therapy (described below), were introduced to the concept of mood and AOD monitoring (as per Beck et al., 1979; Beck et al., 1993) and asked to complete a daily mood/AOD monitoring task over the coming week. Participants allocated to Person-Centred Therapy (PCT) were asked to consider the issues discussed during the session as their only homework. THERAPIST-DELIVERED SHADE THERAPY SHADE therapy consisted of ten individual sessions of therapy, one week apart, including the first session described above as session one. SHADE therapy offered nine additional treatment sessions to participants designed to encourage a reduction in depression and AOD use. SHADE therapy incorporated motivational, behavioural and cognitive components, based on the work of Segal et al. (2002), Persons et al. (2001), Graham (2004), Beck et al. (1979; 1993) and Tarrier and Wells (1998). Participants took responsibility for any change that occurred throughout treatment, including deciding on their goals for therapy, such as a choice between complete abstinence from substances or a level of reduced, controlled usage (a harm reduction goal). Each of the SHADE therapy session was structured and manualised as per the following: Session 1: as described above; Session 2: Mood/AOD monitoring continues in the context of a rationale for cognitive behaviour therapy (CBT). Mindfulness training is commenced and activity scheduling introduced. Motivation enhancement continues in this session; Session 3: Links between thoughts and behaviours are discussed and thought monitoring commenced specifically around triggers for depression and AOD use. Mindfulness training continues, along with activity scheduling and motivation enhancement; Session 4: Phase II motivational interviewing is commenced and change plans for both AOD and depression are negotiated. Coping with cravings for AOD use is discussed and continues as required through until Session 10. Activity scheduling and mindfulness practice also continues until Session 10; Session 5: Cognitive restructuring is introduced via the concept of identifying and managing unhelpful automatic thought patterns. Restructuring continues through until Session 10. Mindful breathing is introduced and motivation enhancement continues on a needs basis through until Session 10; Session 6: Problem-solving techniques are introduced and applied to both AOD use and depression-relevant situations. Mindfulness training focusses on breathing with regular practice encouraged; Session 7: Schema change methods are introduced and continue until Session 10; Session 8: Refusal skills are practiced and an emergency plan developed for both cravings for AOD and depressive symptoms. Mindfulness training continues using the theme of allowing and letting things be; Session 9: The concepts of “seemingly irrelevant decisions” and the abstinence/rule violation effect are introduced in the context of both AOD use and depression. Preventing relapse is discussed, and a plan developed for investing time in enjoyable and achievement activities and avoiding activities that tax resources; Session 10: A relapse management plan is developed that involves both AOD and depression, and treatment is terminated. The research clinician reviewed depression and AOD use status of the participant during this session to determine the need for further intervention from another source. Referral to available treatment sources in the community was arranged where appropriate. COMPUTER-DELIVERED SHADE THERAPY The content of computer-delivered SHADE therapy was identical to that described for therapist-delivered SHADE therapy above. The computer-delivered SHADE CD-ROM contained interactive components, including video demonstrations, voiceovers and in-session exercises. The video components modelled CBT/mindfulness and other skills relevant to the therapy (activity scheduling, self-monitoring thoughts, challenging faulty cognitions, identifying cognitive schema, drink/drug refusal and problem solving). The CD-ROM was menu-driven, and participants were instructed to complete the nine sessions in sequence, one week apart, as per the clinician-delivered intervention. Participants were able to preview future sessions and review previous sessions throughout the treatment program. Text presented in the SHADE CD-ROM was pitched at a reading level consistent with that of a person who has completed up to Year eight at high school in Australia (approximate age: 12-13 years). A similar computer-based intervention among problem drinkers, written at the eighth grade reading level was acceptable and comprehensible by all participants (Hester & Delaney, 1997). Session one was completed face-to-face with a ‘live’ clinician, as per the description provided above. After completion of session one, participants randomly allocated to computer-delivered SHADE therapy proceeded as follows. Computer-delivered SHADE therapy sessions were delivered according to the following format: * Greet the person: the SHADE participant was greeted briefly upon arrival by the research clinician, and taken to the SHADE computer for their session. Interaction with the person was limited to non-specific topics, unrelated to SHADE therapy or participation in the research project (e.g. the weather). * Introduce the module: for the first computer module (i.e. session two, following completion of session one face-to-face), the research clinician and the participant completed the introductory SHADE module together. This brief (approximately 5 minute) tutorial module oriented the person to the computer program, showed them how to use the mouse and keyboard, and taught them how to navigate their way through the program. Once complete, and for subsequent computer-delivered SHADE modules, the research clinician briefly prepared the participant for computer therapy in the following way: “Today I have set up Module XX on the computer for you to complete. You can go backwards and forwards through the computer program by clicking the mouse, and I’ve put a pen and some paper here for you to make notes if you would like to. You can also see that there is a printer connected to the computer, so you can print out any worksheets or other information whenever you wish. It’s OK to get up and walk around a little bit during the session, just to make sure you keep comfortable. Allow yourself about one hour to complete this module. I’ll come back into the room after about one hour to see how you are going.” * Commence the module: the research clinician left the participant to work through the computer-based SHADE module/session. * Brief check-in: following completion of the SHADE computerised module, the research clinician met briefly with the participant for a “check-in” session of 10-15 minutes’ duration. The content of this “check-in” was manualised, and in summary, comprised the following elements: * Review Homework Activities: To check the participant’s understanding of the assigned homework tasks, they were asked to describe the homework tasks in their own words. Research clinicians reinforced the importance of homework and its relevance to future modules. * Develop a Plan for Completing Homework: Research clinicians and participants briefly explored any anticipate obstacles to completing homework activities, and developed and verbalised a plan for doing homework tasks through the week. * Suicide and Mood Assessment: the research clinician used the brief ‘check-in’ to provide a general idea of their current mood. Where indicated, the research clinician conducted a suicide risk assessment with the person. * Confirm Next Appointment: the person’s next appointment was confirmed prior to completing the session.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants in the study were people with comorbid depression and current problematic use of alcohol or cannabis. To be eligible for the study, people were required to satisfy the following criteria: * Current depressive symptomatology, as indicated by a score of 17 or greater on the Beck Depression Inventory II (BDI-II, Beck, Steer, & Brown, 1996); * Current problematic use of at least one of the following: alcohol (i.e. consumption above recommended drinking levels as suggested by the National Health and Medical Research Council (NHMRC); equates to 4 standard drinks per day for men or 2 standard drinks per day for women with fewer than 2 alcohol free days per week); or cannabis (at least weekly use); * Absence of a brain injury, organic brain disease and/or significant cognitive impairment; and * Ability to understand English.
Exclusion criteria
Participants were considered ineligible if they were: (i) not using alcohol or cannabis above harmful thresholds; (ii) scored below 17 on the BDI-II; (iii) were under 16 years of age; (iv) were currently diagnosed with a psychotic disorder; (v) lacked fluency in English; or (vi) reported a history of traumatic brain injury.