Improving Outcome Through Improving Cognition in Severe Mental Illness: Cognitive Remediation Training Combined With Transcranial Direct Current Stimulation, a Randomized, Sham-controlled, Multi-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 6
- 主要终点
- Independent Living Skills Survey self- and observer-rated questionnaire (ILSS)
研究概览
简要总结
Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training.
详细描述
A fundamental challenge for many people with severe mental illness (SMI) is dealing with the impact of cognitive impairments in daily life functioning. A possible treatment approach is cognitive remediation training (CR), a training developed to target cognitive deficits with the ultimate aim to improve daily functioning. Participants engage in cognitive exercises, learn more about their own cognition and the use of (cognitive) strategies to compensate for deficits. However, in people with SMI, abnormal synaptic plasticity is observed. This might hinder newly learned cognitive skills to sustain and limit the benefits from CR. For this reason, people with SMI may benefit from the combination of CR with a method that may promote neural plasticity: transcranial direct current stimulation (tDCS).
In a pragmatic, triple-blinded, randomized, sham-controlled, multi-center trial with a multiple baseline design, we will investigate the effectiveness of combining CR and tDCS in helping participants reach personal goals, minimizing problems in daily functioning and improving cognitive functioning. 126 service users with SMI will receive 16-20 weeks of twice-weekly CR combined with active (N=63) or sham tDCS (N=63). We will perform functional, cognitive, and clinical outcome assessments at baseline, after a 16-week waiting period, post-treatment and 6-months post-treatment and compare the effects within-participants (waiting period vs. treatment period) and between-participants (CR+active tDCS vs. CR+sham tDCS). Further, an optional in-depth interview will be conducted post-intervention (T2) to investigate subjective experiences of CR and its perceived effect on metacognition, daily functioning, helpful components, and areas for improvement.
This multi-center trial will evaluate whether CR on its own and whether CR in combination with tDCS can be a clinically relevant addition to further enhance recovery through enhancing service users' goal attainment, daily functioning and cognitive performance. In case results of this trial confirm our hypotheses, it may be recommended to include the combined information in the guidelines for SMI care and to implement the method in standardized care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to CR + sham tDCS (group 1) or CR + active tDCS (group 2) with a 1:1 allocation as per a computer-generated randomization plan using permuted blocks of random sizes. The block sizes will not be disclosed to ensure concealment. As such, both the researcher as the participant can stay blind to the tDCS treatment condition. Also, the assessors who will do neuropsychological tests are blind to the condition the participant is in and are blind to the type and aim of the treatment. After finishing measurement T2, the participants can indicate if they suspect to have experienced either the real or the sham tDCS treatment. The patients will be informed about the type of treatment they have received when all participants completed measurement T3.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A psychiatric disorder that requires care/treatment (no remission of positive, negative and cognitive symptoms);
- •Severe disabilities in social and/or societal functioning (no functional remission);
- •Disabilities are the result of a psychiatric disorder;
- •Disabilities are structural (at least several years);
- •Coordinated professional care is necessary to realize a treatment plan;
- •Adults between the age of 18 and 65;
- •Sufficient written and oral mastery of the Dutch language.
排除标准
- •Having previously received CIRCuiTS;
- •Metal implants inside the skull or eye;
- •Severe scalp skin lesions;
- •A history of previous seizures;
- •Alcohol or drug abuse.
研究组 & 干预措施
active tDCS + CR
For active tDCS, the current will be 2 mA and will be administered for 20 min with a fade-in/out of 30 s. The anode will be positioned at Fp1 and the cathode at C3, following the 10-20 system.
干预措施: Cognitive remediation + active tDCS (Other)
sham tDCS + CR
For the sham tDCS, the fade-in will be identical as for the active tDCS. After 30 s the current will fade-out over 30 s. In addition to those above, a standard control pulse, with no therapeutic effect, will be frequently sent to monitor electric conductivity (~ 0.02mA in duration of 3 s, send every 0.55 s). The anode will be positioned at Fp1 and the cathode at C3, following the 10-20 system.
干预措施: Cognitive remediation + sham tDCS (Other)
结局指标
主要结局
Independent Living Skills Survey self- and observer-rated questionnaire (ILSS)
时间窗: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
The Independent Living Skills Survey (ILSS) is a questionnaire that measures the basic functional living skills of individuals with SMI. The ILSS will be completed by the participant and by the participant's case manager.
Goal Attainment Scale (GAS)
时间窗: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
This questionnaire is a measure to capture self-reported recovery goals in a structured way, which has also been used in rehabilitation practice. Based upon an interview, the participant defines up to three personal recovery goals that can be scored and weighted on importance and difficulty for which a scoring manual is available.
Social Functioning Scale (SFS)
时间窗: Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment
The SFS is a standard measure that was developed and validated for people with schizophrenia and includes the following subscales: social engagement or withdrawal, interpersonal functioning, current social activities, recreational activities, independence-competence, independence-performance, and employment.
Behapp application
时间窗: Throughout the entire study period, up to 16 months (including baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
Behapp is a smartphone app that was developed to objectively and passively measure sociability and social exploration. After installation, Behapp will continuously monitor measures of communication events (e.g., incoming and outgoing phone calls), app activity (e.g., social media or entertainment apps), and location via GPS. Data are encrypted before saving on the participants' device and deleted immediately after uploading to the secured data server. The content of calls, SMS messages, and apps will not be registered, collected, or saved by Behapp.
次要结局
- Social Functioning Scale (SFS)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Behapp application(Throughout the entire study period, up to 16 months (including baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment))
- Controlled Oral World Association Task (COWAT)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Trail Making Test (TMT)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Digit span (forward & backward)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Wechsler Memory Scale - Visual Reproduction I and II(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Stroop Color and Word Task (SCWT)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- 15 Word Test (15-WT)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Cognitive Failure Questionnaire (CFQ)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Self-Evaluation of Negative Symptoms (SNS)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- DEX self/informant(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- General Self-Efficacy Scale (GSES)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- Nurses' Observation Scale of Cognitive Abilities (NOSCA)(Baseline (16 weeks before start of treatment), pre-treatment, post-treatment (after 16-20 weeks of treatment) and 6-months post-treatment)
- In-depth interview(Post-treatment (after 16-20 weeks of treatment))