Combination of Neurostimulation and Psychotherapy to Stop Worrying

NCT06369532 | Recruiting

• 1 other identifier: ONZ-2023-0460
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate whether the combination of transcranial Direct Current Stimulation (tDCS) and cognitive-behavioral therapy (CBT) is more effective for treating repetitive negative thinking (RNT) in patients with the symptom of high rumination. High ruminators will be included (Group1, active tDCS-CBT group; Group2, sham tDCS-CBT group). All patients will receive active or sham tDCS.

Conditions

Active tDCS; Sham tDCS

Keywords

transcranial direct current stimulation

Outcome Measures

Primary Outcomes (2)

• the therapeutic effect of the combination therapy for repetitive negative thinking

  Questionnaires including the Penn State Worry Questionnaire (PSWQ, range 16-80), the Leuven adaptation of the rumination on sadness Scale (LARSS, range 21-105) , and the Ruminative Response Scale (RRS, range 22-88) will be used to measure the alteration of repetitive negative thinking. Higher scores suggest a higher level of worry or rumination. The Beck Depression Inventory (BDI), the Hamilton Depression Rating Scale (HDRS) and other related questionnaires will also be included.

  Baseline, up to 7 weeks' therapy and up to 3 months' therapy

• the consolidation effect of tDCS on CBT

  The Self-Critical Rumination scale (SCRS, range 0-40) and the Perseverative Thinking Questionnaire (PTQ, range 0-60) will be measures after each session (8 sessions in total). Higher scores suggest a higher level of self-critical ruminative thoughts or repetitive negative thinking.

  up to 7 weeks' therapy and up to 3 months' therapy

Secondary Outcomes (1)

• Change of neuroimaging data

  Baseline and up to 3 months' therapy

Study Arms (2)

Active tDCS group

ACTIVE COMPARATOR

Patients will receive active tDCS during the therapy.

Device: Active tDCS

Sham tDCS group

SHAM COMPARATOR

Patients will receive sham tDCS during the therapy.

Device: Sham tDCS

Interventions

Active tDCS DEVICE

During the whole therapy period, active tDCS group will receive active tDCS after CBT. They also receive active home-based tDCS.

Active tDCS group

Sham tDCS DEVICE

The sham tDCS group will receive sham tDCS after CBT. They also receive sham home-based tDCS.

Sham tDCS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generalized anxiety disorder (GAD)
• Depressive disorder

You may not qualify if:

• other psychiatric pathology than GAD or depression screened by senior psychiatrist by means of the Mini-International Neuropsychiatric Interview (MINI) and psychiatric anamnesis
• Abuse of alcohol, drugs or medication other than prescribed by general practitioner or psychiatrist
• no consent to participate in measurement (questionnaire, fNIRS or EEG)
• Insufficient knowledge of the current language (Dutch)
• Acute or chronic suicidality
• Acute psychosis or manic depressive disorder
• Inability to commit to 8 sessions of Cognitive-Behavioral Therapy (CBT) or receive 4 weeks of transcranial Direct Current Stimulation (tDCS).

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Related Publications (3)

• Baeken C, Wu GR, Rogiers R, Remue J, Lemmens GM, Raedt R. Cognitive behavioral based group psychotherapy focusing on repetitive negative thinking: Decreased uncontrollability of rumination is related to brain perfusion increases in the left dorsolateral prefrontal cortex. J Psychiatr Res. 2021 Apr;136:281-287. doi: 10.1016/j.jpsychires.2021.02.011. Epub 2021 Feb 13.

  PMID: 33621914 RESULT

• Sathappan AV, Luber BM, Lisanby SH. The Dynamic Duo: Combining noninvasive brain stimulation with cognitive interventions. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:347-360. doi: 10.1016/j.pnpbp.2018.10.006. Epub 2018 Oct 9.

  PMID: 30312634 RESULT

• Dedoncker J, Baeken C, De Raedt R, Vanderhasselt MA. Combined transcranial direct current stimulation and psychological interventions: State of the art and promising perspectives for clinical psychology. Biol Psychol. 2021 Jan;158:107991. doi: 10.1016/j.biopsycho.2020.107991. Epub 2020 Nov 21.

  PMID: 33232800 RESULT

Study Officials

• Chris Baeken

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Baeken

CONTACT

+32476209841; Chris.Baeken@ugent.be

Sara De Witte

CONTACT

+32498382824; sara.dewitte@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be allocated into two groups randomly (using a code). The psychotherapist, the study managers and the patients will not be aware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: April 17, 2024
• Study Start: March 6, 2024
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)