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Activation Therapy for the Treatment of Inpatient Depression

Randomised controlled trial of Activation Therapy versus Treatment As Usual for the treatment of cognitive impairment in inpatients admitted with depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000024347
Enrollment
97
Registered
2017-01-09
Start date
2019-02-04
Completion date
2023-07-27
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Depression is a common and serious problem. Patients who are admitted for treatment of depression are generally the most severely affected with the greatest degree of depressive and cognitive symptoms (difficulty with thinking, memory, and organising). Existing treatments of depression largely consist of medications and psychotherapies (talking treatments). However, these treatments are limited for a number of reasons including partial response rates (not helping everybody who takes the treatment), incomplete responses (only improving depression somewhat), and persisting cognitive symptoms despite improvements in mood. These factors are all linked to poor functional recoveries (failure to return to previous level of functioning) and risk of depression returning. Current treatment of depression on a psychiatric ward largely provides a secure setting that minimises the risk of suicide whilst medications take effect. Unfortunately, the evidence for non-medication strategies to improve the care of inpatients with depression is not well established and largely preliminary in its findings. This study, therefore, seeks to improve the evidence base for non-medication strategies for inpatients with depression. Behavioural Activation is a treatment that has predominantly been studied in outpatient depression studies with good evidence for its effectiveness. Behavioural Activation helps people by assisting them to increase their activity levels. Cognitive Activation is a new treatment that is increasingly being evaluated for depression and other mental disorders. Cognitive activation stimulates under-active areas of the brain with on-line computer games. We have combined Behavioural Activation and Cognitive Activation to create Activation Therapy (AT). We believe that this combination of treatments provides the best chance of helping people with severe inpatient depression. Our study will assess whether AT given in addition to usual treatment (Treatment As Usual (TAU)) on a psychiatric ward is better than TAU for inpatients with depression. If patients agree to participate in the study, they will be randomly chosen to either have Activation Therapy and TAU or TAU alone. Our main goal is to assess whether or not Activation Therapy will reduce re-admission to hospital in the 12 weeks following discharge. We will also measure cognitive function, symptoms of depression, functioning, and total time spent in hospital to help us understand if Activation Therapy is useful for inpatients with depression.improves the cognitive deficits caused by depression.

Interventions

8 x 30-40 minute therapist sessions of Activation Therapy on-site at the psychiatric unit (4/week) and 10 x online practise sessions over 2 weeks (5/week) in addition to Treatment as Usual (see comparator treatment). Activation Therapy consists of two components. Cognitive Activation and Behavioural Activation. Cognitive Activation is the use of therapist guided computerised cognitive exercises from a programme called Scientific Brain Training Pro (https://www.scientificbraintrainingpro.co

8 x 30-40 minute therapist sessions of Activation Therapy on-site at the psychiatric unit (4/week) and 10 x online practise sessions over 2 weeks (5/week) in addition to Treatment as Usual (see comparator treatment). Activation Therapy consists of two components. Cognitive Activation and Behavioural Activation. Cognitive Activation is the use of therapist guided computerised cognitive exercises from a programme called Scientific Brain Training Pro (https://www.scientificbraintrainingpro.com/ - provided free of charge for this study). These exercises are designed to activate parts of the brain that are under-active with depression. This system has been selected based on its use of tasks with flexibility to alter level of difficulty to meet the individual’s current functioning, ease of use and delivery in an attractive interactive format. Therapists will select cognitive tasks suitable for the patient’s current level of functioning from a menu of tasks, and in later sessions, review progress. Collaborative practice, encouragement and coaching will take place. Therapists will be experienced registered nurses, social workers, or psychologists familiar with the requirements of ward environments and working within multi-disciplinary teams. Patients will be encouraged to practise the exercises in-between therapy sessions to reinforce and build on learning occurring during therapy. Patients will focus on the exercises used in therapy when doing the on-line practise sessions. Behavioural Activation occurs alongside the Cognitive Activation in the therapy led sessions. Behavioural Activation involves identification of both positive and negative reinforcers maintaining depressive symptoms and behaviours, and of reinforcers that promote more adaptive behaviours (i.e. those that re-engage the depressed person with previously rewarding or potentially rewarding aspects across the important domains of life). Personal values are identified and activities focussed on those values are considered. A graded hierarchy of pleasurable activities and activities that give the patient a sense of competency is then chosen and worked through collaboratively with the patient. Collaborative problem-solving of difficulties in undertaking the tasks occurs. Training/adherence Activation Therapy will be delivered according to our Activation Therapy manual by mental health professionals trained and closely supervised with a focus on adherence and competence. Fidelity checklists of core strategies delivered during each sesson will be completed by therapists after each session to ensure all elements are delivered. A random selection of 10% of audiotaped sessions will be listened to by a supervisor and scored according to the Quality of Behavioral Activation Scale. Participant adherence will be measured by the 9-item Short Form Behavioral Activation Scale (BADS-SF) completed by participants at baseline, session 4 and session 8. A single question self-rating the extent of practice of Behavioural Activation activities within the past 24 hours will be completed by participants at each session. The frequency and duration of on-line cognitive activation exercises will also be monitored through the Scientific Brain Training Pro programme.

Sponsors

Professor Richard Porter
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Individuals admitted to the participating psychiatric inpatient units with a primary diagnosis of depression, who are computer literate and able to complete questionnaires and therapy in English.

Exclusion criteria

Primary diagnosis of schizophrenia Current severe alcohol or drug use disorder Comorbid serious endocrinological, neurological or chronic medical condition Pregnancy Previous severe head injury Electro-convulsive therapy (ECT) in the past six months or ECT planned for the current admission

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026