Home-Based tDCS for Depression in BPD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

The present study aims to assess the feasibility of home-based tDCS in remote and urban areas (primary objective).

The secondary aim is to obtain a preliminary assessment of the efficacy of 14 home-based tDCS sessions in reducing depressive symptoms in BPD patients with moderate to severe depressive episodes and BPD symptoms.

Exploratory objectives include assessing the impact on neuropsychological and psychosocial functioning, anxiety, physical activity, sleep disorders, and addiction.

Additionally, we aim to investigate the sociodemographic and clinical factors that are linked to the most favorable response to tDCS in addressing both depressive and BPD symptoms.

We also aim to assess the feasibility of using a smartwatch as an outcome measure in this population.

Finally, we intend to gather preliminary data on the effectiveness of an online psychoeducational program specifically designed for patients with BPD.

Researchers will compare active tDCS to sham tDCS to see if active treatment is more effective in treating depression in this population.

Participants will:

* Receive 14 sessions of either active or sham tDCS over one week, delivered at home * Complete psychological and neurocognitive assessments at baseline, post-treatment, and at 6 weeks * Wear actigraphy monitors and complete questionnaires to assess sleep, physical activity, and other mental health outcomes

This trial will also explore the feasibility of delivering tDCS in both urban and rural settings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

To be aged between 18 and 65.

To meet the DSM-IV criteria for BPD.

To present a moderate depressive episode, defined as a MADRS score ≥ 20 (V1 and V3).

To be capable to consent to participate in the study.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • tDCS

    Device

    Description: Participants randomized to this arm will receive 14 sessions of home-based transcranial Direct Current Stimulation (tDCS), administered twice daily for 30 minutes over 7 consecutive days. Each session will use a 2mA current with a SNAPstrap™ montage targeting the left dorsolateral prefrontal cortex (F3) with the anode and the right DLPFC (F4) with the cathode. Sessions include a 30-second ramp-up and ramp-down. The total delivered charge will be 48 coulombs. Enhancement component: Each session will be paired with cognitive and emotional enhancement strategies: Emotion regulation script (DBT-inspired, personalized and pre-written based on a moderately dysregulated situation). Cognitive training via Lumosity, targeting executive functions and memory.

  • Treatment as Usual (TAU)

    Procedure/Surgery

    Description: Throughout the study, participants are required to maintain stable pharmacological and psychotherapeutic regimens, defined as: No changes in medications or therapy for at least 6 weeks after tDCS initiation. TAU is provided by participants' regular treating physician or mental health professional, independent of the study team. TAU includes psychotropic medication, psychotherapy, and case management, as clinically indicated.

  • Psychoeducation

    Procedure/Surgery

    All participants receive access to a structured online psychoeducation program before randomization. This includes: * Short videos (8-14 minutes each) covering BPD, depression, neuromodulation, therapeutic success factors, and tDCS. * Multiple-choice quizzes (MCQs) to ensure comprehension. * Delivered in French with English subtitles. Designed to improve understanding of BPD and associated treatments, including the rationale for tDCS.

  • Sham-tDCS

    Device

    Description: Participants randomized to this arm will receive 14 sessions of sham tDCS, with identical scheduling and device setup as the active condition. The session mimics real tDCS (same SNAPstrap montage, ramp-up and ramp-down of 30 seconds), but no current is delivered after the initial 30 seconds. Enhancement component: Participants follow the same emotional regulation script and Lumosity cognitive training during

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: tDCSExperimental treatment 3 interventions
Group B: Sham tDCSPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Feasibility and Acceptability of Home-Based tDCS

* Recruitment Rate: Percentage of eligible patients agreeing to participate. * Adherence Rate: Over 75% of participants completed at least 12 of the 14 tDCS sessions scheduled * Participant Satisfaction: Assessed using a Visual Analog Scale (VAS) at V5. * Tolerability: The questionnaire of sensations related to transcranial electrical stimulation (TES) is administered after each tDCS stimulation session to assess tolerability and monitor potential adverse effects. This questionnaire evaluates common side effects, including itching, tingling, burning sensations, headache, discomfort, and dizziness. One time per week, the questionnaire will add a question on suicidal ideation. We will use the cumulative percentage of side effects for all sessions (one week of stimulation). * Acceptability of psychoeducation: Adherence Rate: Percentage of patients completing 90% of psychoeducation (at least 9 videos) according to the Moodle online course

Time frame
Baseline (Day 0), Week 1 (Day 7), Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham), Month 3

Secondary outcomes

1

Borderline Symptom List (BSL-23)

The BSL-23 is a 23-item self-report questionnaire designed to assess the severity of BPD symptoms over the past week (higher scores indicate more severe symptoms). This shortened version of the BSL-95 is widely used for routine monitoring of BPD. The assessment takes approximately 10 minutes to complete. The BSL-23 demonstrates excellent internal consistency, with a Cronbach's alpha of roughly .94 for the French version.

Time frame
Baseline (Day 0), Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham), Week 6 and Month 3.
2

Quick Inventory of Depressive Symptomatology (QIDS)

Quick Inventory of Depressive Symptomatology (QIDS): The QIDS is a 16-item self-report questionnaire based on DSM-IV criteria for major depression. It assesses symptom severity over the past 7 days (higher is more severe) and takes approximately 5 to 10 minutes to complete. The assessment has good internal consistency, with a Cronbach's alpha of 0.69 to 0.89 (75). It has been translated into French.

Time frame
Baseline (Day 0), Week 1 (Day 7), Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham), Week 6 and Month 3.
3

Borderline Personality Disorder Severity Index (BPDSI)

The BPDSI is a 70-item semi-structured interview designed to assess the frequency and severity of BPD symptoms over the past three months. It captures critical symptoms and behaviours associated with BPD, such as self-harm, emotional dysregulation, and interpersonal conflicts. The interview takes approximately 45 to 60 minutes to complete. The BPDSI yields highly reliable (ICC = .93) and internally consistent (Cronbach's α = .85) scores. The BPDSI has been translated into French and used in clinical research, although its psychometric properties have not yet been validated for the French version.

Time frame
Pre-intervention (immediately prior to tDCS/sham) and Month 3.
4

Personality Disorder Severity Scale (PDS-ICD-11)

The PDS-ICD-11 is a clinician-rated instrument designed to assess the severity of personality disorder features by the International Classification of Diseases, 11th Revision (ICD-11). This scale evaluates impairments in self-functioning (identity and self-direction) and interpersonal functioning (empathy and intimacy), the core components of personality pathology defined by the ICD-11 framework. The PDS-ICD-11 provides a dimensional assessment, categorizing severity into five levels: no personality dysfunction, personality difficulty, mild personality disorder, moderate personality disorder, and severe personality disorder. This nuanced approach allows for a standardized and comprehensive evaluation of personality dysfunction, facilitating both diagnosis and the monitoring of treatment outcomes. A version has been translated into French.

Time frame
Pre-intervention (immediately prior to first tDCS/sham), Post-intervention (within 1 day after of tDCS/sham).

Other outcomes

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