None listed
Conditions
Brief summary
Mood disorders (major depressive disorder and bipolar disorder) seen in secondary care in New Zealand are highly recurrent, long-term conditions. Following short-term stabilisation of acute mood episodes, most patients continue to experience ongoing symptoms, relapses, and functional impairment. A significant factor contributing to functional impairment, and to burden of symptoms and relapse, is cognitive impairment. Persisting cognitive impairment after recovery from a mood episode occurs in a high percentage of patients. Our research has focused on examining psychological treatments which may promote full functional and symptomatic recovery in recurrent mood disorders. We have examined the effects on mood disturbance and cognitive function of adding a specific psychological treatment, Interpersonal and Social Rhythms Therapy (IPSRT), to usual treatment of mood disorders. IPSRT resulted in a reduction in symptom burden in this study, however, improvement in cognitive function was relatively limited. A subsequent study added cognitive remediation (CR; a treatment specifically targeted at reducing cognitive impairment) to IPSRT in patients who have been discharged from SMHS. Our experience in this study suggests that CR commenced at the start of the stabilisation period is likely to be sub-optimal because of the level of mood symptoms which patients are experiencing at this stage. Research suggests that a group format for CR may be more efficient and produce more engagement from patients. Thus, the proposed clinical trial will examine the effectiveness of group-based CR as an adjunct to IPSRT, in improving cognitive function (primary outcome), mood disturbance and general functioning, in patients with mood disorders. Biological measures of inflammatory markers and hormone levels in females will also be assessed over time. Patients with a DSM-5 diagnosed mood disorder will be recruited at discharge from SMHS and will receive IPSRT to stabilise mood. After 6 months of IPSRT, patients will be randomised to additional group-based CR (IPSRT-CR) or no additional treatment (IPSRT alone). Follow-up assessments will occur at 18 months and 24 months.
Interventions
IPSRT was developed for Bipolar Disorder (Ellen Frank). The three main elements of IPSRT include: 1) psychoeducation, 2) interpersonal strategies for problems in relationships (5 problem areas), and 3) behavioural strategies to stabilise routine and reduce social/circadian rhythm disruption. IPSRT is delivered according to a manualised protocol. IPSRT begins with an assessment which includes the completion of an ‘Illness History Timeline’, and ‘Interpersonal Inventory’, and feeding back the psychological formulation to the patient within the IPSRT framework. During this phase, patients also begin completing the Social Rhythm Metric, which involves the patient documenting key social rhythms and their mood rating on a daily basis. During the middle phase of IPSRT, patients will be working on stabilisation of their social rhythms (continuing to use the Social Rhythm Metric if appropriate), and sleep hygiene strategies will be provided as part of this. For the ‘interpersonal’ aspect of therapy, the patient and therapist collaboratively choose one or two primary interpersonal problem areas to focus on that clearly relate to the patient's mood (either: 1) Interpersonal Disputes, 2) Role Transitions, 3) Grief and Loss, 4) Interpersonal Sensitivity, and/or 5) Grief for the Lost Healthy Self). Strategies for this phase include: psychoeducation, communication analysis, relationship appraisal, expression of affect, role-play, perspective taking, assertiveness skills training, and problem-solving. Handouts for the assessment and therapy phase of treatment can be found and uploaded at https://www.ipsrt.org/. Training of therapists involved training from the original developers of IPSRT through the University of Pittsburgh (Professor Holly Swartz), online training (https://www.ipsrt.org/), and then supervision in two training cases with an experienced IPSRT therapist. Seven therapists will be providing IPSRT on this trial: 4x mental health nurses, 1x social worker, 2x clinical psychologists. Each patient will have one therapist for the duration of the study. All have had experience providing IPSRT in previous clinical trials. IPSRT sessions will be between 50 to 60 minutes in duration and completed in an individual, face-to-face format. Sessions will be weekly for 12 weeks, followed by fortnightly (approximately 10 sessions), and then monthly sessions (4 sessions), making a total of about 24 sessions over the 12-month treatment period. If there is deterioration in the patient’s mood, they may be seen more regularly. Therapy will be face-to-face in an individual format. IPSRT sessions will take place in a Clinical Research Unit (Department of Psychological Medicine, University of Otago, Christchurch, NZ), in specifically designed therapy rooms. IPSRT therapy supervision will be provided to the IPSRT therapist by an experienced IPSRT therapist on a fortnightly basis. Therapists will tape approximately 10% of their sessions in order to assess fidelity of treatment. GROUP-BASED COGNITIVE REMEDIATION A Cognitive Remediation (CR) intervention is being delivered in order to improve cognitive and functional outcomes in our sample with mood disorders. The Group-Based CR intervention will be provided in the second 6-months of this 12-month treatment trial. Materials required for treatment include a Samsung tablet for each patient, headphones, worksheets, and equipment required for simulated role-plays. This group-based CR treatment is based on the Action-Based Cognitive Remediation (ABCR) treatment manual (Christopher Bowie, 2018). In the current study, ABCR has been adapted for the New Zealand context, and has been shortened to eight sessions in the same format. The principal investigator (KD) has been trained in this treatment approach and will lead the training of therapists in the current RCT. Group-based CR will involve weekly, 90-minute, face-to-face sessions over 8 weeks (i.e., 8 sessions). Each group session will involve three main components: - Practice of computerised exercises, which will be provided by Scientific Brain Training Professional (SBT-Pro; www.scientificbraintrainingpro.com). - Coaching on strategies to improve performance - ‘Bridging’ - use of role-play and group exercises to help transfer skills and strategies used in computerised exercises to everyday functioning. In terms of treatment content, sessions include the following, in the same order: - Didactic introduction: outlining the theme of the day (e.g., ‘Shifting Your Focus’). - Skill building with computerised cognitive training: therapists will demonstrate the computer task on a large screen, then there will be about 10 minutes of computer practice. A group strategy discussion follows, and then these strategies are tested with a further 10 minute computer practice session. - Real-world simulations: therapists will demonstrate the simulation (reminding group members about strategies from the computerised cognitive exercise) and then the group engages with the simulation. - Cognitive activation and goal setting: a bridging discussion about how the computerised exercises and real-world simulations relate to activities in everyday life and personal goals, followed by identification of cognitively stimulating activities for homework before the next session. Groups will be conducted in a rolling structure, so that patients will continually be starting and ending the treatment as they complete their dose of treatment. Treatment will take place in the Clinical Research Unit (Department of Psychological Medicine, University of Otago, Christchurch, NZ). Outside of group CR sessions, patients will be expected to practise computerised exercises online every day (for at least 30 minutes), with therapists being able to provide individual online feedback. Treatment adherence can be assessed by observing online how many practice sessions each patient has completed each week, and for how many minutes. Group therapists will consist of: 1x clinical psychologist and 3x mental health nurses, all experienced in the provision of psychological therapy. Therapists have been trained by KD in this CR intervention. A CR fidelity checklist will be completed by KD to ensure treatment is being delivered according to protocol. MEDICATION MANAGEMENT All patients in the study will have an initial, face-to-face session with a psychiatrist who will assess medication needs. The assessing psychiatrist will then see the patient at 6 months and 12 months to monitor response to medication. Sessions will be between 30-60 minutes in length. Patients will be seen more regularly if deemed necessary by the therapist, psychiatrist, or patient. Psychiatrists will prescribe medication according to Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults ( > 18 years) with diagnosed mood disorder (BD I, BD II, BD NOS or MDD), confirmed with SCID-I. Recently (within 3 months) discharged from Specialist Mental Health Services in Canterbury, Self- or clinician-reported cognitive impairment.
Exclusion criteria
Schizophrenia or schizoaffective disorder; severe alcohol or drug dependence; history of severe brain injury (loss of consciousness greater than 1 hour); previous course of cognitive remediation or electroconvulsive therapy in past 12 months; serious neurological or medical condition affecting cognitive function, pregnancy.