None listed
Conditions
Brief summary
Aim To compare a 12-month intervention involving Interpersonal and Social Rhythms Therapy combined with Cognitive Remediation (IPSRT-CR), with IPSRT alone, on cognitive functioning, everyday functioning, and mood morbidity in patients with a recurrent mood disorder. Primary Hypothesis IPSRT-CR, compared with IPSRT alone, will result in significantly improved cognitive functioning over the 12-month treatment period. Secondary Hypotheses a) IPSRT-CR will be associated with improved cognitive functioning at 18-month follow-up compared with IPSRT alone b) IPSRT-CR will be superior to IPSRT alone in improving general functioning over the course of treatment and during the 12-month follow-up period c) Overall mood related morbidity will be less during the treatment and in the 12-month follow-up period in patients randomised to the IPSRT-CR intervention Sample One hundred and sixty adults with mood disorder (bipolar disorder I or II, or Bipolar NOS or major depressive disorder (MDD)) will be recruited on discharge from SMHS in Canterbury, Nelson/Marlborough and Wellington. Interventions The 12-month IPSRT-CR intervention will involve IPSRT and Cognitive Remediation, the latter delivered by computer and supervised by therapists. The control intervention will be IPSRT alone (i.e., without the Cognitive Remediation component). Time spent with the therapist will be the same for each group. Interpersonal and Social Rhythm Therapy IPSRT will be delivered according to a manualised protocol. IPSRT will involve weekly sessions for 10-12 weeks followed by 8 fortnightly, and then 4 monthly sessions (total 24 sessions). If there is deterioration in the patient’s mood, they may be seen more regularly. All sessions will be audio-taped and randomly selected and rated to ensure adherence to therapy protocols. All therapists will participate in regular and ongoing supervision. Cognitive Remediation Patients will be introduced by their therapists to a computerised cognitive remediation package (provided free of charge by Scientific Brain Training Professional (SBT-pro) - www.scientificbraintrainingpro.com). This will begin between weeks 7-9 and will continue at the 8 fortnightly sessions (12 CR sessions in total). Patients will be asked to undertake three practice sessions per week between therapy sessions. Therapists will provide on-line feedback once between face-to-face sessions. After 12 sessions, the package will continue to be available to patients should they wish to continue to practice. Tasks completed during the therapy session will include: a) reviewing performance and progress b) discussing strategy on individual tasks and formulating a range of problem solving strategies c) relating strategy to real-life situations d) selecting new tasks from the battery available
Interventions
Interpersonal and Social Rhythm Therapy combined with Cognitive Remediation.
IPSRT (Frank, 2005) is an integrative psychotherapy combining interpersonal psychotherapy (Klerman and Weissman, 1982) which targets interpersonal stressors such as interpersonal conflicts, role transitions and losses; with social rhythms therapy (aimed at establishing regularity in life patters such as sleeping, eating and social contact to stabilise circadian patterns). Both elements aim to stabilise functioning to mi
Interpersonal and Social Rhythm Therapy combined with Cognitive Remediation. IPSRT (Frank, 2005) is an integrative psychotherapy combining interpersonal psychotherapy (Klerman and Weissman, 1982) which targets interpersonal stressors such as interpersonal conflicts, role transitions and losses; with social rhythms therapy (aimed at establishing regularity in life patters such as sleeping, eating and social contact to stabilise circadian patterns). Both elements aim to stabilise functioning to minimise recurrence of mood episodes. IPSRT will be delivered on an individual basis in the clinic according to a manualised protocol. IPSRT will involve weekly sessions for 10-12 weeks followed by fortnightly for approximately 8 sessions, and then approximately 4 monthly sessions for the rest of the 1 year duration of treatment (total approximately 24 sessions). If there is deterioration in the patient’s mood, they may be seen more regularly and will be coded “crisis”. Care will be taken to minimise variation around the total number of sessions between groups. All sessions will be audio-taped and randomly selected and rated to ensure adherence to therapy protocols. All therapists will participate in regular and ongoing supervision. Patients in the CR arm will be introduced by their therapists to a computerised cognitive remediation package (provided free of charge by Scientific Brain Training Professional (SBT-pro) - www.scientificbraintrainingpro.com). This will begin between weeks 7-9 (after allowing time for engagement with the therapist) and will continue at the 8 fortnightly sessions (12 CR sessions in total). Cognitive Remediation will be integrated into the IPSRT sessions. Patients will be asked to undertake three CR practice sessions per week between therapy sessions (length depending on clinical state) for the three months of the CR intervention. Therapists will provide on-line feedback once between face-to-face sessions. After 12 sessions, the package will continue to be available to patients for the rest of the intervention (i.e. until 12 months post baseline) should they wish to continue to practice. Therapist tasks completed during the therapy session will include: a) reviewing performance and progress b) discussing strategy on individual tasks and formulating a range of problem solving strategies c) relating strategy to real-life situations (according to the manual of Bowie, Gupta and Holshausen) d) selecting new tasks from the battery available. Detailed information on patient adherence to prescribed CR practice sessions is available from the CR website, which gives information on practice sessions (dates, duration, tasks practiced, accuracy and speed).
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or over 2. At point of discharge from Community Outpatient teams of Specialist Mental Health Services 3. Bipolar I, II or NOS or Major Depressive Disorder (can be in a current episode) 4 Subjective cognitive difficulties reported by the patient or judged by his/her referring clinician
Exclusion criteria
IPSRT in the last 18 months CR in the last 6 months Primary diagnosis of severe substance use disorder Diagnosis of schizophrenia or schizoaffective disorder ECT in the last 6 months History of severe brain injury (loss of consciousness > hour) Engaged in other therapy concurrently Diagnosis of neurodegenerative disease
Outcome results
None listed