RESET-psychotherapy: the Effectiveness of Trauma-focused Therapy in Patients With Depression and Childhood Trauma

NCT05149352 | Unknown

• 1 other identifier: NL74405.029.20
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

Brief Summary

Depression is a debilitating psychiatric disorder with a recurrent and progressive course. Around 25% of depressive patients has experienced moderate to severe levels of childhood trauma (CT), resulting in earlier onset and more severe and recurrent depressions. There is currently no targeted treatment for CT-related depression. This is problematic as patients with CT-related depression respond poorly to standard depression treatments. The RESET-psychotherapy study proposes an innovative, targeted disease-modifying treatment strategy for CT-related depression. The main objective is to investigate the effectiveness of trauma-focused therapy (TFT), as an addition to regular depression treatment ('treatment as usual'; TAU), in reducing depression symptom severity in patients with CT-related depression. 158 adult patients will be randomized to receive a 12-week treatment with 1) TAU or 2) TFT in combination with TAU. The primary outcome measure is defined as depression symptom severity after 12 weeks treatment (post-treatment), measured with the Inventory of Depressive Symptomatology - Self Rated (IDS-SR).

Conditions

Major Depressive Disorder; Childhood Trauma

Keywords

Depression; Childhood trauma; Trauma-focused; Psychotherapy; Treatment; EMDR; Imagery rescripting

Outcome Measures

Primary Outcomes (1)

• Depressive symptom severity at post-treatment

  Depressive symptom severity in patients with CT-related depression, measured with the Inventory of Depressive Symptomatology - Self Report (IDS-SR, with a total score ranging from 0 to 84, where higher scores indicate higher severity of depressive symptoms)

  Up to 12 weeks (post-treatment)

Secondary Outcomes (2)

• Depressive symptom severity during treatment and at 9 months follow-up

  Up to 9 months (follow-up)

• Remission in CT-related depression

  Up to 9 monts (follow-up)

Other Outcomes (14)

• Functional disability

  Up to 9 months (follow-up)

• Anxiety symptoms

  Up to 9 months (follow-up)

• Insomnia

  Up to 9 months (follow-up)

Study Arms (2)

Treatment as usual (TAU)

ACTIVE COMPARATOR

Participants will receive an evidence-based psychotherapeutic intervention combined with/or pharmacotherapy (TAU)

Behavioral: Treatment as usual (TAU) for depression

Treatment as usual (TAU) + Trauma-focused therapy (TFT)

EXPERIMENTAL

Participants will receive 6 to 10, 60-90 minute TFT sessions delivered over a period of 12 weeks, in addition to TAU.

Behavioral: Treatment as usual (TAU) for depression; Behavioral: Trauma-focused therapy (TFT)

Interventions

Treatment as usual (TAU) for depression BEHAVIORAL

TAU for depression will be largely determined by the Dutch multidisciplinary practice guideline on depression (Spijker et al., 2013). This means that patients with CT-related depression will receive good clinical care, e.g. evidence-based psychotherapeutic interventions, such as cognitive behavioral therapy (CBT) or interpersonal therapy (IPT) combined with/or pharmacotherapy. Therapists who give TAU are not allowed to provide a trauma-focused intervention aimed at CT during the 12-week intervention period.

Treatment as usual (TAU); Treatment as usual (TAU) + Trauma-focused therapy (TFT)

Trauma-focused therapy (TFT) BEHAVIORAL

The content of TFT, delivered by another therapist than the therapist that will provide TAU, depends on the type of CT the patient reports. If the patient predominantly reports experiences of abuse, there are often clear memories of this abuse ('target images') present and Eye Movement Desensitization and Reprocessing (EMDR) is recommended as the treatment strategy. If the patient predominantly reports experiences of neglect, memories are often less identifiable, although these experiences can have a big impact on the development of maladaptive schemas. In this case, imagery rescripting (ImRs) is recommended as treatment strategy. If the patient reports both experiences of abuse and neglect, the therapist will discuss with the patient which type of CT has the greatest impact on the current depressive symptoms and starts with the indicated therapy. If indicated, the therapist can switch between EMDR and ImRs after a minimum of 4 sessions.

Treatment as usual (TAU) + Trauma-focused therapy (TFT)

Eligibility Criteria

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

You may qualify if:

• Moderate to severe depression, defined by a score ≥ 26 on the Inventory of Depressive Symptomatology - Self Rated (IDS-SR)
• DSM-5 diagnosis of MDD confirmed with the Dutch translation of the MINI-S for DSM-5
• Moderate to severe childhood trauma (CT) before the age of 18, defined by a score above validated cut-off on one or more of the following domains of the 28-item Childhood Trauma Questionnaire Short Form (CTQ-SF):
• physical neglect: score ≥ 10
• emotional neglect: score ≥ 15
• sexual abuse: score ≥ 8
• physical abuse: score ≥10
• emotional abuse: score ≥ 13
• Sufficient mastery of Dutch language

You may not qualify if:

• Previous TFT on CT
• Other lifetime severe psychiatric comorbidity (bipolar disorder, psychotic disorder)
• Current alcohol/drug dependence
• Primary diagnosis of post-traumatic stress disorder (PTSD) or Acute Stress Disorder (ASD)
• Lifetime diagnosis of borderline personality disorder (BPD)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Stichting tot steun VCVGZ: collaborator
• HSK Groep B.V.: collaborator
• Altrecht: collaborator

Study Sites (3)

GGZ inGeest

Amsterdam, North Holland, 1081HJ, Netherlands

RECRUITING

HSK Groep

Woerden, Utrecht, 3447GN, Netherlands

RECRUITING

Altrecht

Utrecht, 3524SH, Netherlands

NOT YET RECRUITING

Related Publications (7)

• Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.

  PMID: 17074942 BACKGROUND

• McLaughlin KA, Green JG, Gruber MJ, Sampson NA, Zaslavsky AM, Kessler RC. Childhood adversities and adult psychiatric disorders in the national comorbidity survey replication II: associations with persistence of DSM-IV disorders. Arch Gen Psychiatry. 2010 Feb;67(2):124-32. doi: 10.1001/archgenpsychiatry.2009.187.

  PMID: 20124112 BACKGROUND

• Teicher MH, Samson JA. Childhood maltreatment and psychopathology: A case for ecophenotypic variants as clinically and neurobiologically distinct subtypes. Am J Psychiatry. 2013 Oct;170(10):1114-33. doi: 10.1176/appi.ajp.2013.12070957.

  PMID: 23982148 BACKGROUND

• Nanni V, Uher R, Danese A. Childhood maltreatment predicts unfavorable course of illness and treatment outcome in depression: a meta-analysis. Am J Psychiatry. 2012 Feb;169(2):141-51. doi: 10.1176/appi.ajp.2011.11020335.

  PMID: 22420036 BACKGROUND

• Spijker J, Bockting C, Meeuwissen J, Van Vliet I, Emmelkamp P, Hermens M, et al. Multidisciplinaire richtlijn Depressie (Derde revisie): Richtlijn voor de diagnostiek, behandeling en begeleiding van volwassen patiënten met een depressieve stoornis. Trimbos Instituut: Utrecht. 2013

  BACKGROUND

• Driessen A., ten Broeke E. Schematherapie en EMDR gecombineerd bij complexe traumagerelateerde problematiek. Tijdschrift voor Gedragstherapie; 2014.

  BACKGROUND

• Gathier AW, Verhoeven JE, van Oppen PC, Penninx BWJH, Merkx MJM, Dingemanse P, Stehouwer KMKS, van den Bulck CMM, Vinkers CH. Design and rationale of the REStoring mood after early life trauma with psychotherapy (RESET-psychotherapy) study: a multicenter randomized controlled trial on the efficacy of adjunctive trauma-focused therapy (TFT) versus treatment as usual (TAU) for adult patients with major depressive disorder (MDD) and childhood trauma. BMC Psychiatry. 2023 Jan 17;23(1):41. doi: 10.1186/s12888-023-04518-0.

  PMID: 36650502 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Christiaan H Vinkers, Prof. dr.

  Amsterdam UMC, location VUmc and GGZ inGeest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anouk W Gathier, Drs.

CONTACT

0031207884675; a.gathier@ggzingeest.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As the interventions in these studies are psychotherapies, both participants and care providers cannot be masked from the treatment allocation. To ensure the objectivity of the research measures, the outcome assessors will be blinded to the allocated treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. mr. C.H. Vinkers

Model Details: Participants will be randomized to one of two treatment conditions. In one condition (control group) participants will receive a regular depression treatment that they would usually receive for their depression ('treatment as usual', TAU). In the other condition (intervention group) participants will receive trauma-focused therapy (TFT), additional and parallel to their depression treatment (TAU). In both treatment groups (TAU and TAU+TFT), treatment will be provided during a period of 12 weeks.

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 8, 2021
• Study Start: November 10, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication, no end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

NL (3)