Designing and clinical trial of a therapeutic intervention for codependency disorder among codependent wives of Iranian opioid and/or stimulant users

To compare the effectiveness of the integrated codependency intervention, Community Reinforcement and Family Training (CRAFT), and psychoeducation based on the Matrix protocol on codependency levels and quality of life among spouses of individuals with substance use disorder.

A randomised block clinical trial with three arms of 14 participants each (total 42). To reduce bias, block randomisation was performed using the SealedEnvelope website. After informed consent, participants randomly select a sealed envelope, assigning them to one of the groups. Allocation of envelopes to study centers is done by simple randomization.

Select substance use treatment clinics in Isfahan and Tehran

Minimum age of 18 years, having a spouse undergoing treatment for substance use, no current or past substance use disorder or acute psychosis based on DSM-5 criteria, scoring at least 52.6 on the Spann-Fisher questionnaire, and willingness to participate with informed consent.

1)Integrated codependency intervention consisting of 11 sessions covering case history, motivational interviewing, understanding addiction and maladaptive behaviours, codependent roles, breaking dysfunctional family cycles, managing obsessive thoughts, problem solving, and emotion regulation. 2)Standard CRAFT therapy; 3)Psychoeducation based on the Matrix model. All groups have an equal number and duration of sessions.

Codependency scale in participants

Due to the practical limitations in enrolling all participants in the intervention and control groups simultaneously, we use block randomisation to assign participants. A total of 42 eligible participants who signed the informed consent form will enrol in a clinical trial involving three intervention arms: 1)Integrated Codependency Intervention, 2)Community Reinforcement and Family Training (CRAFT), and 3)Psychoeducational Group Therapy based on the Matrix protocol. Participants were randomly allocated to one of the three groups using block randomisation with blocks of size three, generated by the SealedEnvelope.com online system to minimise the risk of bias. The randomisation list was generated using the website’s simulation tool. Each unique participant ID, along with the corresponding assigned group, will be placed in a separate, sealed, and opaque envelope. After signing the consent form, each eligible participant was asked to randomly draw an envelope, which, once opened, revealed the participant's ID and assigned group. The allocation was then confirmed and documented according to the pre-generated randomization list. Envelope sets were distributed to study centers using simple randomization.

De-identified data collected from study participants will be entered into a secure database. After publication of the study results, these data will be made available upon reasonable request to the corresponding author, provided that all personally identifiable information has been removed to ensure participant confidentiality.

Following the publication of the articles resulting from the study

Access to the data or study documentation may be granted to researchers with relevant or overlapping research interests, provided they submit a reasonable justification for their request.

No specific restrictions apply to the use of the data, provided the source is properly cited.

Requests for data should be directed to the corresponding author of the article(s) resulting from the study.

Data or documentation requests must be submitted in writing via email to the corresponding author of the article(s) resulting from the study. The request should include a clear introduction of the applicant, institutional affiliation, purpose of the request, and specific details regarding the data or documents being sought. Upon receipt, the research team will review the request within 10 business days. If approved, de-identified data will be prepared and shared. The estimated timeframe from submission to data delivery is approximately 2 to 4 weeks, depending on the complexity of the request. Access will only be granted if the intended use aligns with ethical standards and ensures participant confidentiality. Proper citation of the original publication is required in any secondary use of the data.