BA Trial for Co-Occurring Depression and Substance Use
Condition: Depression; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      A large proportion of people seeking treatment for drug and alcohol issues also have
      clinically significant depression symptoms. This combination of problems tends to have a
      negative impact on treatment and leads to poor health and disability, yet relatively few
      studies have focused on the development of interventions for treating this comorbidity. There
      is emerging evidence to suggest that Behavioural Activation (BA) may be a viable and
      cost-effective treatment for comorbid depression and substance use problems, however more
      research is needed in order to establish its effectiveness in routine practice. The aim of
      this study is therefore to investigate the efficacy of a brief (6-session), manualised BA
      intervention among service users with depression who are accessing Community Drugs and
      Alcohol treatment. We are planning to recruit up to 128 service users who are actively using
      substances to be randomly assigned to either the 6-week BA intervention or Treatment as Usual
      in Community Drugs and Alcohol services. These participants will be recruited from either a
      Community Drugs and Alcohol service or a Community Mental Health service. Our research will
      assess whether the BA intervention is more effective than usual care in (1) reducing
      depression symptoms, (2) reducing substance use, and (3) improving treatment engagement (i.e.
      session attendance). We expect that our results will establish the efficacy of integrating BA
      for depression into routine Community Drugs and Alcohol Treatment.
    

Detailed description: 
      RATIONALE Over 50% of treatment-seeking substance users present with clinically significant
      depression symptoms (Johnson, Neal, Brems, & Fisher, 2006). This combination of problems
      tends to complicate treatment (e.g. Carroll et al., 1993) resulting in greater functional
      impairment (Johnson et al., 1995) and poor health outcomes (Hasin et al., 2002). Treatment
      protocols for co-occurring mental health and substance misuse have traditionally focused on
      treating these issues separately, however there is now increasing consensus that integrated
      approaches to treatment are more effective (Davidson et al., 2010) and subsequently a growing
      interest into how targeted mental health support can be incorporated into standard drug and
      alcohol treatment.

      CBT is deemed to be one of the most effective psychological treatments for depression, though
      may be too complex and time-consuming for effective delivery in routine CDAT. Emerging
      evidence suggests that a more suitable intervention in this context may be Behavioural
      Activation (BA); a brief, manualised intervention which targets depression symptoms by
      increasing engagement in rewarding, values-based activities (Lejuez, Hopko, Acierno,
      Daughters, & Pagoto, 2011). Indeed, previous studies have found that BA is associated with
      reductions in both depression symptoms and substance use (Daughters et al., 2018; Daughters
      et al., 2008; Delgadillo et al., 2015), as well as improved treatment retention among
      substance misuse service users with comorbid depression (Magidson et al., 2011). The only
      known trial of BA in UK Community Drugs and Alcohol Treatment (CDAT) was conducted by
      Delgadillo and colleagues (2015), however this study was under-powered and employed qualified
      mental health practitioners to deliver the intervention which may be too costly or unfeasible
      to implement in routine practice. More research is needed to establish the efficacy of BA in
      CDAT services, and given that BA may be delivered effectively with minimal training by staff
      who are not formally trained as psychological therapists (Ekers et al., 2008), it seems that
      the most suitable and cost-effective way of integrating BA into routine drug and alcohol
      treatment would be to upskill the existing workforce.

      Accordingly, given the high prevalence and impact of comorbid depression among addiction
      service users, along with evidence to suggest that BA is an effective and acceptable
      intervention for treating this population, the present study will expand on previous research
      by conducting a trial to evaluate the efficacy of BA delivered by trained drugs and alcohol
      workers in a sample of patients accessing treatment for substance use. The central research
      question is: How effective is Behavioural Activation for treating depression in substance
      users compared to treatment as usual in Community Drugs and Alcohol services?

      AIMS

      The proposed study aims to:

        1. Evaluate the efficacy of brief one-to-one manualised BA delivered by trained drugs and
           alcohol workers in a CDAT setting in terms of depression outcome

        2. Evaluate the efficacy of delivering manualised BA in this setting in terms of substance
           use and engagement (attendance and dropout rates) outcomes

      HYPOTHESES

      Participants who receive the BA intervention will show improvements in:

        1. Depression symptoms

        2. Substance use

        3. Treatment Engagement (sessions attended, % dropout)

      CLINICAL IMPLICATIONS If the BA intervention is found to be more effective than the usual
      care offered in CDAT services, this trial will provide evidence for the intervention to be
      implemented in routine practice. Even if the BA intervention is not found to be more
      effective, the results of this study will contribute to understanding of what works and what
      doesn't work in this setting, which can be used to inform the development of future
      interventions aimed at addressing co-occurring substance use and depression.

      DESIGN This study is a pragmatic, parallel group, randomised controlled trial assessing the
      efficacy of BA compared to treatment as usual (TAU) for patients with depression who are
      accessing CDAT services. Outcome measures will be taken at baseline, 3-, 6-, 12- and 24-weeks
      to enable the comparison of relative efficacy.

      METHOD Participants will be recruited from CDAT services in the UK. They will be working age
      adults (18-65) with mild to moderate depression who are actively using substances. The study
      aims to recruit 142 participants in total.

      PROCEDURE Drugs and alcohol workers in CDAT services will employ a step-wise mental health
      screening strategy as part of routine practice in order to identify potential participants.
      This strategy involves routinely completing TOP and brief mental health questionnaires
      sequentially in order to identify patients with common mental disorders.

      Potential participants will be provided with an information sheet and asked for permission to
      pass their details on to the research team.

      Consenting participants will be contacted by a member of the research team within one week to
      conduct eligibility screening and obtain informed consent. Participants will be aware of
      confidentiality arrangements for the study, that their participation is voluntary and that
      they have the right to withdraw at any time.

      Once consent to participate has been established, the identified clients' details will be
      passed on to an independent administrator for randomisation.

      Participants will be randomly allocated into one of two arms ('BA Intervention' or 'Treatment
      as Usual'). Participants randomised to Treatment as Usual will continue to receive their
      usual care at the CDAT service. Participants randomised to the BA intervention will receive 6
      x weekly one-to-one sessions of BA plus 2 booster sessions at 2-3 and 4-5 weeks
      post-treatment. BA will be delivered by drugs and alcohol workers who have completed 2 days
      of training in delivering the BA intervention. Staff delivering the intervention will also
      receive an extra hour of supervision once per month with a supervisor-trained supervisor
      which will be focused on delivery of the BA intervention.

      To ensure fidelity to the BA treatment protocol, drugs and alcohol workers delivering the BA
      intervention will complete a checklist at the end of each session indicating their adherence
      to the session protocol, with the checklist for each session highlighting specific session
      objectives. Additionally, drugs and alcohol workers will be asked to audiotape at least two
      of their sessions at random over the course of the study. Audiotaped therapy sessions will be
      rated using the rating scales from Magidson and colleagues' (2011) study by an independent
      evaluator with an understanding of behavioural activation strategies. Independent evaluators
      will be Psychological Wellbeing Practitioners with experience of delivering BA, the Study
      Coordinator, or students under the supervision of the Study Coordinator. Issues of
      non-adherence will be considered a training implication representative of areas for
      improvement to be addressed via standard supervisory procedures. Non-adherence will not
      preclude data inclusion for the purposes of this study; instead it will be addressed as a
      limitation of the study related to therapist experience.

      DATA ANALYSIS Screening, recruitment, random allocation and treatment engagement (including
      dropout) data will be summarised using a CONSORT diagram. The integrity of randomisation,
      demographic and clinical characteristics will be assessed by comparing between groups and
      between recruitment sites using appropriate statistical tests. Loss to follow-up has been
      estimated at 20% based on a previous feasibility study of BA conducted in this setting
      (Delgadillo et al., 2015). Intention-to-treat analyses will be conducted using Last
      Observation Carried Forward method in order to account for the loss to follow-up. Secondary
      to this, we will analyse the data only with participants who completed all of the follow-up
      assessments in order to check that findings were not unduly affected by attrition.

      We will calculate and report standardised effect sizes for depression outcome (PHQ-9) using
      Cohen's d. Severity of depression at 12-week follow-up will be considered the main outcome
      for the calculation of effect sizes; although we will also report 6- and 24-week follow up
      data for comparison. Severity of depression at 12-week follow-up will be compared
      between-groups using Analysis of Covariance with participant's pre-treatment scores on the
      PHQ-9 used as covariates. This is to counter potential baseline variance in depression that
      may influence results and was considered robust for relatively small sample sizes in a
      similar study of BA (Ekers et al., 2011).

      For both intervention and control groups, we will present the proportions of participants who
      had reliable and clinically significant change (RCSC) in depression status at 6, 12 and 24
      weeks. The RCSC outcome definition (Jacobson & Truax, 1991) has been recommended as a
      standard reporting strategy for all published research involving psychological interventions
      (Evans et al., 1998).

      Pre-post changes scores will also be calculated and reported for substance use outcomes
      (Percent Days Abstinent and Severity of Dependence). Percent days abstinent will be
      considered the primary substance use outcome. We will calculate and report standardised
      effect sizes for percent days abstinent at 12-week follow-up using Cohen's d, with 6- and
      24-week follow-up data reported for comparison. Percent days abstinent at 12-week follow-up
      will then be compared between groups using Analysis of Covariance, with participant's
      pre-treatment scores on the SDS entered as a covariate to account for potential baseline
      variance in severity of dependence that may influence results. Changes in SDS scores pre-post
      treatment will be compared between groups using Student's t-test.

      For both intervention and control groups, we will present the proportions of participants who
      had reliable and clinically significant change (RCSC) in percent days abstinent and severity
      of dependence at 6, 12 and 24 weeks based on guidelines by Jacobson and Truax (1991).

      The mean number of key-working sessions offered to participants in the Treatment as Usual arm
      during the 6-week intervention period will be reported. Percentage of sessions attended will
      then be compared between groups using Student's t-test.

      SAMPLE SIZE CALCULATION Based on previous research conducted in the USA, an effect size of
      0.5 was used to calculate the required sample size (Daughters et al., 2018; Daughters et al.,
      2008). Standard sample size calculation based on a medium effect size (0.5) with 2
      independent sample means indicates that 128 participants (64 per group) would be required to
      achieve 80% power using a significance level (p) of 0.05. After accounting for the
      possibility that an estimated 10% of participants may drop out of the study (i.e. withdraw
      consent), this means that we will need to recruit 142 participants in total (71 per group). A
      previous feasibility study conducted by Delgadillo and colleagues (2015) indicated a screened
      to recruited ratio of 4:1 in this setting, therefore we will aim to screen a minimum of 568
      participants sequentially over a 2-year period in order to achieve an adequate sample size
      for this study.
    

Intervention name(s): Behavioural Activation; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The BA intervention will be the outpatient version of the Life Enhancement Treatment for Substance Use (LETS ACT; Daughters et al., 2008). This brief, manualised BA intervention has been specifically developed to meet the needs of patients with comorbid substance misuse and depression in drugs and alcohol treatment settings. LETS ACT targets the link between mood, substance use and behaviour, and focuses on identifying and increasing rewarding, substance-free activities that are based on the patient's own personal values.; The control intervention in this study is Treatment as Usual at the CDAT service. Treatment as Usual consists of planned key-working sessions every 2-4 weeks with an allocated caseworker plus monthly prescribing review appointments with a medical practitioner for patients who require drug treatment medication. Key-working sessions are primarily focused on addressing substance misuse issues using a range of intervention techniques such as motivational interviewing and brief solution-focused therapy.
Other intervention name(s): LETS ACT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a pragmatic, parallel group, randomised controlled trial assessing the efficacy of BA compared to treatment as usual (TAU) for patients with depression who are accessing Community Drugs and Alcohol Treatment.
Masking: None (Open Label)
Primary purpose: Treatment