Treatment of PTSD and Addiction

Treating posttraumatic stress disorder in patients with co-occurring substance use disorders: a randomized controlled trial to compare the effectiveness of different types and timings of treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27175

Enrollment

205

Registered

2019-07-22

Start date

2019-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Co-occurring posttraumatic stress disorder and substance use disorder

Interventions

All participants will receive regular SUD treatment plus either one of the following PTSD interventions: Prolonged Exposure, 12 sessions, twice a week

Eye Movement Desensitization and Reprocessing, 12 sessions, twice a week

Imagery Rescripting, 12 sessions, twice a week. For all participants, regular SUD treatment will start shortly after baseline assessment. Participants randomized to simultaneous SUD/PTSD treatment wi

Eligibility

Inclusion criteria

Inclusion criteria: - age 18 years or older; - substance use disorder(s) according to the Diagnostic and Statistical Manual of Mental Disorders 5 criteria (DSM-5), with the primary diagnosis involving one of the following substances: alcohol, cannabis, cocaine (snorting), amphetamines, benzodiazepines, opioids; - posttraumatic stress disorder according to the DSM-5 criteria; - sufficient understanding of the Dutch language.

Exclusion criteria

Exclusion criteria: - acute psychotic disorder; - mental retardation or cognitive impairment (IQ<70); - current physical or sexual abuse or death threats; - current acute suicidal behavior; - life threatening self-mutilation; - homelessness; - involvement in a compensation case or legal procedures concerning admission or stay in the Netherlands; - involvement in legal procedures regarding the index trauma; - engagement in any other current PTSD treatment.

Design outcomes

Primary

Measure	Time frame
Severity of PTSD symptoms as measured with the Clinician Administered PTSD Scale for DSM 5 (CAPS-5).	—

Secondary

Measure	Time frame
Measured by therapist: - Completion of PTSD treatment (yes/no); - Completion of SUD treatment (yes/no); Measured during assessments: - Psychological distress (Brief Symptom Inventory (BSI)); - Alcohol and drug use problems (Alcohol Use Disorder Identification Test (AUDIT) and Drug Use Disorder Identification Test (DUDIT)); - Substance use (MATE-Q-nl module 1); - Interpersonal problems (Inventory of Interpersonal Problems (IIP-32)); - Emotion dysregulation (Difficulties in Emotion Regulation Scale (DERS)); - Trauma-related guilt (Trauma Related Guilt Inventory (TRGI)); - Trauma-related shame (Trauma Related Shame Inventory (TRSI)); - Internalised and externalised anger, and anger control (Zelf Expressie en Controle Vragenlijst (ZECV)); - (Recent) victimization and (recent) perpetration (LEC-5 with minor extension); - Impulsivity and working memory, measured with neurocognitive tasks. Measured at start of each therapy session: - PTSD symptoms (PTSD checklist for DSM-5 (PCL-5); - Substance use in the past days. Economic evaluation: An economic evaluation will be conducted alongside the randomized trial and will be performed according to the intention-to-treat principle. We will evaluate the relationship between costs, as measured with the Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) – and health outcomes of treatments. We will perform both a cost-effectiveness analysis with PTSD symptoms as effect measure and a cost-utility analysis using QALYs, based on the EuroQol 5D (EQ-5D-5L).	—

Measure

Time frame

Measured by therapist: - Completion of PTSD treatment (yes/no); - Completion of SUD treatment (yes/no); Measured during assessments: - Psychological distress (Brief Symptom Inventory (BSI)); - Alcohol and drug use problems (Alcohol Use Disorder Identification Test (AUDIT) and Drug Use Disorder Identification Test (DUDIT)); - Substance use (MATE-Q-nl module 1); - Interpersonal problems (Inventory of Interpersonal Problems (IIP-32)); - Emotion dysregulation (Difficulties in Emotion Regulation Scale (DERS)); - Trauma-related guilt (Trauma Related Guilt Inventory (TRGI)); - Trauma-related shame (Trauma Related Shame Inventory (TRSI)); - Internalised and externalised anger, and anger control (Zelf Expressie en Controle Vragenlijst (ZECV)); - (Recent) victimization and (recent) perpetration (LEC-5 with minor extension); - Impulsivity and working memory, measured with neurocognitive tasks. Measured at start of each therapy session: - PTSD symptoms (PTSD checklist for DSM-5 (PCL-5); - Substance use in the past days. Economic evaluation: An economic evaluation will be conducted alongside the randomized trial and will be performed according to the intention-to-treat principle. We will evaluate the relationship between costs, as measured with the Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) – and health outcomes of treatments. We will perform both a cost-effectiveness analysis with PTSD symptoms as effect measure and a cost-utility analysis using QALYs, based on the EuroQol 5D (EQ-5D-5L).

—

Contacts

Public ContactMarleen de Waal

Arkin

marleen.de.waal@arkin.nl0031205905895

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)