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Trial registered on ANZCTR


Registration number
ACTRN12610000274077
Ethics application status
Approved
Date submitted
29/03/2010
Date registered
6/04/2010
Date last updated
6/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The SHADE (Self-Help for Alcohol/other drug use and DEpression) project: Computerised treatment for depression and alcohol/other drug use comorbidity in rural and urban New South Wales, Australia.
Scientific title
Randomised controlled trial to compare depressive symptoms, alcohol and cannabis use following therapist- versus computer-delivered cognitive behaviour therapy+motivational interviewing for people with depression and alcohol/other drug use comorbidity.
Secondary ID [1] 1570 0
None
Universal Trial Number (UTN)
U1111-1114-5697
Trial acronym
The SHADE project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 257050 0
alcohol misuse 257051 0
cannabis misuse 257052 0
Condition category
Condition code
Mental Health 257213 257213 0 0
Addiction
Mental Health 257241 257241 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256227 0
Treatment: Other
Intervention code [2] 256255 0
Behaviour
Intervention code [3] 256256 0
Lifestyle
Comparator / control treatment
PERSON –CENTRED THERAPY – CONTROL (PCT)
This treatment was adapted for the project from the unpublished manual: Sellman, J.D., Sullivan, P.F, and Dore, G.M. (Unpublished). Brief Treatment Programme for Alcohol Dependence: Person-Centred Therapy Therapists Manual. Copyright, Christchurch School of Medicine. It was included as a means to control for therapist (live) contact, but not for the content of the active SHADE interventions.

Person-centred therapy is a form of psychotherapy originally developed by Carl Rogers in the 1940’s. This treatment adopts the assumption that every individual has the capacity to make personal changes and has the ability and resources within themselves to make the necessary changes for personal growth to occur. If certain conditions are present within the therapeutic relationship, the client will be able to use this capacity to make positive changes.

The conditions which are provided for in PCT have been identified as non-specific factors of all successful psychotherapies. Here they are considered the specific principles of PCT. These essential factors that the therapist must provide are:
1. Genuineness or congruence,
2. Unconditional positive regard, and
3. Accurate empathy.

In PCT, therapists do not engage in the following: undue probing, give reassurance, criticise, praise, describe the client, interpret current behaviour in the light of past experiences, provide advice, or giving directions. The therapist allows the client to focus on their own inner experiences without trying to direct them in any way. The focus is on the here-and now. No attempt is made to gain an understanding of the client’s past experiences. The environment provided by the therapy allows the client to begin to look at those feelings and thoughts which have previously been too anxiety-provoking to consider. This can act as a catalyst for change.

Changes which may occur as a result of PCT include the following:
* The client becomes aware of feelings which were previously denied, feared or struggled against. The client becomes more comfortable expressing these feelings as they occur.
* The client becomes aware of the differences between inner feelings and outward actions. These feelings are then allowed to influence behaviour in a way that is appropriate.
* The client becomes aware of existing problems and no longer sees them as being external to themselves. The client begins to own his or her part in contributing to the problem and seeks the solution to problems from within.
* The client shifts from being fearful of close relationships to cautiously testing relationships; eventually being able to express feelings in a relationship as they occur.
* The client moves from disapproval of themselves towards greater self-acceptance.

PCT was delivered individually over a total of ten therapy sessions, including the session one described above. Each session lasted around an hour, applying the three key principles of PCT (genuineness, unconditional positive regard and accurate empathy) to a 10 week therapeutic relationship with a client with depression and an alcohol and or drug dependency. In general, the three phases of therapy might be expected to correlate with session 2, sessions 3-9, and session 10 respectively. However, there is likely to be considerable variation within clients, from the situation where most of the 10 sessions are spent engaging into the therapeutic relationship, to the other extreme, where after rapid engagement the client begins to anticipate termination from the first session onwards.

The most common techniques used in the sessions were open-ended questions and reflective listening. Open-ended questions were used to maintain a nondirective therapeutic stance, conveying to the client, that they are responsible for the direction of therapy. Reflective listening was used to “stay with” the client, as they led the process of therapy. This technique assisted the therapist to keep on track with the line of discussion being taken by the client, as well as to convey to the client that the therapist is attentive to their thoughts and feelings.

Closed questions were only be used as clarification in the service of accurate empathy. Although the focus of PCT is on the here and now, if the client wished to talk about the past or future, this was up to them. If the client became “stuck” the therapist simply empathised with them rather than offering any advice or suggestions.

This control treatment was not used in the previous randomised controlled trial (ACTRN12607000437460)
Control group
Active

Outcomes
Primary outcome [1] 258103 0
Depressive symptoms (as measured by the Beck Depression Inventory II)
Timepoint [1] 258103 0
Baseline
3-months post-baseline
6-months post-baseline
12-months post-baseline
Primary outcome [2] 258104 0
Alcohol use (as measured by the Opiate Treatment Index)
Timepoint [2] 258104 0
Baseline
3-months post-baseline
6-months post-baseline
12-months post-baseline
Primary outcome [3] 258105 0
Cannabis use (as measured by the Opiate Treatment Index)
Timepoint [3] 258105 0
Baseline
3-months post-baseline
6-months post-baseline
12-months post-baseline
Secondary outcome [1] 263708 0
Therapeutic alliance (as measured by the Agnew Relationship Measure)
Timepoint [1] 263708 0
Following completion of Sessions 1, 5 and 10 of therapy
Secondary outcome [2] 263709 0
Cognitive vulnerability to depression (as measured by the Dysfunctional Attitude Scale)
Timepoint [2] 263709 0
Baseline
3-months post-baseline
6-months post-baseline
12-months post-baseline
Secondary outcome [3] 263710 0
Alcohol abuse/dependence (as measured by the Alcohol Use Disorders Identification Test (AUDIT) and the Structured Clinical Interview for DSM-IV, Research Version (SCID-RV))
Timepoint [3] 263710 0
Baseline
6-months post-baseline
12-months post-baseline
Secondary outcome [4] 263711 0
Cannabis abuse/dependence (as measured by the Cannabis Use Disorders Identification Test (CUDIT) and the SCID-RV)
Timepoint [4] 263711 0
Baseline
6-months post-baseline
12-months post-baseline
Secondary outcome [5] 263712 0
Functioning (as measured by the Global Assessment of Functioning)
Timepoint [5] 263712 0
Baseline
3-months post-baseline
6-months post-baseline
12-months post-baseline
Secondary outcome [6] 263778 0
Major Depressive Disorder (as measured by the SCID-RV)
Timepoint [6] 263778 0
Baseline
6-months post-baseline
12-months post-baseline
Secondary outcome [7] 263779 0
Frequency of binge drinking (as measured by question 3 on the AUDIT)
Timepoint [7] 263779 0
Baseline
6-months post-baseline
12-months post-baseline

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study was conducted across two sites in New South Wales: (a) Centre for Metnal Health Studies, University of Newcastle (Hunter Region of New South Wales, Urban); and (b) Centre for Rural and Remote Mental Health, Bloomfield Hospital, (Orange, Rural).

Participants were recruited from a range of sources, including AOD services (detoxification units, methadone clinics, counselling services), Centrelink, Personal Support Programs, outpatient mental health services (community mental health teams, community health centres), psychiatric rehabilitation services and psychiatric in-patient wards. In addition, news articles for the project were placed in the local media, inviting interested persons to self-refer.

Following recruitment to the study, each participant was randomised into one of three treatment conditions: Therapist condition (10 sessions of CBT, face-to-face with a psychologist), Computer condition (10 sessions of CBT using a computer), or Control condition (10 sessions of Person-Centred Therapy, PCT, face-to-face with a psychologist). The first session was conducted face-to-face with all participants, and was identical in content across the conditions. At the conclusion of this initial session, participants were randomised to a further 9 sessions of PCT, CBT or computer-based CBT. Allocations were concealed in individual sealed envelopes labeled with the code, which were opened by participants at the end of Session 1, ensuring that the content and experience of the initial session would be unaffected by knowledge of the allocation. Participants and therapists were blind to treatment allocation until the conclusion of session 1.

Once the treatment phase had been completed, all participants, regardless of dropout, commenced the follow-up phase of the project. Follow-up assessments were conducted with an independent Psychologist, who was blind to treatment allocation. The post-treatment assessment occurred approximately 3 months following the initial assessment, with 6- and 12-month follow-up occurring at 6- and 12-months following completion of the post-treatment assessment.

Assertive follow-up of participants was required to encourage continued participation in the treatment programs. This was in consideration of the research team’s prior experience with comorbid populations and the increasing emergence of literature indicating that a high level of commitment is necessary in order to engage and retain comorbid populations in treatment (Desmond et al., 1995; Stein et al., 2004). In line with the recommendations of Stein et al. (2004) and Desmond et al. (1995) the following procedures were put in place to maximise the retention of participants in the SHADE study:
* Collecting next of kin information at the commencement of the study and gaining consent to contact this person in the event that the participant could not be located using their last known contact information;
* Informing participants about follow-up assessments and appointments at every opportunity, including the use of written confirmation of appointment time/day and confirming attendance the day of the scheduled appointment with a phone call;
* Being flexible and supportive around appointment scheduling;
* Providing resources for travel to attend inital assessment and follow-up sessions; and
* Hiring experienced staff sensitive to the importance of assertive outreach with comorbid clients.

In addition, the following protocol was used when a person missed a treatment session:
(1) The research clinician contacted the participant, arranged an alternative appointment time and sent a handwritten confirmation of the new appointment time/day to the participant’s home address;
(2) On the day of the rescheduled appointment the research clinician telephoned the participant to remind them of the appointment;
(3) If the rescheduled session was also missed, the research clinician telephoned the participant and rescheduled for a second time;
(4) The research clinician contacted the participant on the day of the appointment to remind him/her to attend;
(5) If the appointment was missed again, the research clinician followed steps 1 and 2 and arranged a final appointment time/day convenient to the participant;
(6) If a participant missed three consecutive appointments, they were not assertively followed for further treatment and classified as a treatment dropout.

All participants, regardless of missed appointments, continued to receive follow-up on each of the assessment occasions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomizations were generated at the beginning of the study by the Research Manager at the Newcastle site, and linked to a unique identification code. Randomization was stratified by study site, gender, and presence of concurrent antidepressant or anti-craving medication
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2712 0
2300
Recruitment postcode(s) [2] 2713 0
2800
Recruitment postcode(s) [3] 2714 0
2259
Recruitment postcode(s) [4] 2715 0
2250
Recruitment postcode(s) [5] 2716 0
2325
Recruitment postcode(s) [6] 2717 0
2795

Funding & Sponsors
Funding source category [1] 256727 0
Charities/Societies/Foundations
Name [1] 256727 0
Alcohol Education Rehabilitation Foundation
Country [1] 256727 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 256011 0
None
Name [1] 256011 0
Address [1] 256011 0
Country [1] 256011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258739 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 258739 0
Ethics committee country [1] 258739 0
Australia
Date submitted for ethics approval [1] 258739 0
Approval date [1] 258739 0
30/04/2004
Ethics approval number [1] 258739 0
03/12/10/3.17
Ethics committee name [2] 258765 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 258765 0
Ethics committee country [2] 258765 0
Australia
Date submitted for ethics approval [2] 258765 0
Approval date [2] 258765 0
01/11/2004
Ethics approval number [2] 258765 0
03/12/10/3.17
Ethics committee name [3] 258766 0
Central Coast Area Health Human Research Ethics Committee
Ethics committee address [3] 258766 0
Ethics committee country [3] 258766 0
Australia
Date submitted for ethics approval [3] 258766 0
Approval date [3] 258766 0
01/11/2004
Ethics approval number [3] 258766 0
04/30
Ethics committee name [4] 258767 0
Mid-Western Area Health Human Research Ethics Committee
Ethics committee address [4] 258767 0
Ethics committee country [4] 258767 0
Australia
Date submitted for ethics approval [4] 258767 0
Approval date [4] 258767 0
01/11/2004
Ethics approval number [4] 258767 0
1/04/2004

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30993 0
Address 30993 0
Country 30993 0
Phone 30993 0
Fax 30993 0
Email 30993 0
Contact person for public queries
Name 14240 0
Frances Kay-Lambkin
Address 14240 0
Level 5, McAuley Centre
Calvary Mater Hospital
Waratah NSW 2305
Country 14240 0
Australia
Phone 14240 0
+61 2 4033 5690
Fax 14240 0
+61 2 4033 5692
Email 14240 0
[email protected]
Contact person for scientific queries
Name 5168 0
Frances Kay-Lambkin
Address 5168 0
Level 5, McAuley Centre
Calvary Mater Hospital
Waratah NSW 2305
Country 5168 0
Australia
Phone 5168 0
+61 2 4033 5690
Fax 5168 0
+61 2 4033 5692
Email 5168 0
[email protected]

No information has been provided regarding IPD availability


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