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Completed

NCT Number: NCT05464121

A Blended Intervention for Adjustment Disorder.

The aim of this study is to evaluate the feasibility (including usability and satisfaction) and preliminary effectiveness of a blended intervention for Adjustment Disorder. This intervention combines a self-applied Internet-based program (TAO) with face-to-face sessions with a therapist via videoconference.

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Key information

Conditions

Adjustment Disorders Mental Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Jaume I

Castellon, Castellón, 12071, Spain

About this study

Adjustment disorder (AjD) is one of the most commonly diagnosed disorders in clinical practice. However, although there is still no evidence-based treatment for this problem, Cognitive Behavioral Therapy (CBT) is the most studied. Internet-based treatments emerge as an alternative to reach more people in need while reducing intervention costs. However, high drop-out rates in this format highlight the need to develop new ways of delivering treatments. The present study aims to test a blended treatment for AjD that combines a self-applied CBT programme online (TAO: Adjustment Disorder Online) with face-to-face sessions with a therapist via videoconference every 10-12 days. Only one treatment group has been included and patients will be evaluated at pre-treatment, post-treatment and follow-up (3 and 12 months).

The study will be conducted following the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot and feasibility studies (Eldridge et al., 2016), the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online TeleHealth guidelines (Eysenbach, 2011), and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Chan et al., 2013a; 2013b).

Specific objectives of the study include: (1) To analyse the feasibility of different recruitment and data collection methods (e.g., how broad or restrictive are the eligibility criteria, how willing are patients to participate, time needed to collect data), (2) To explore reasons for non-participation and drop-outs from treatment, (3) To assess patient satisfaction and acceptance of treatment (both quantitatively and qualitatively), (4) In addition, as a secondary objective to explore the potential effectiveness of the treatment at post-treatment and follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Meeting diagnostic criteria for Adjustment Disorder based on the International Classification of Diseases 11 edition (ICD-11).
  • Exceed the cut-off point of 47.5 on the Adjustment Disorder New Module-20 scale (ADNM-20; Lorenz et al., 2016).
  • Sign an informed consent.
  • Ability to understand and read Spanish.
  • Ability to use a computer and having access to the Internet.
  • Having an e-mail address.

Exclusion criteria

  • Presence of risk of suicide or self-destructive behaviors.
  • Presence of another severe mental disorder (substance abuse or dependence, psychotic disorder, dementia, bipolar disorder or personality disorder).
  • Receiving other psychological treatment during the study for AjD.
  • An increase and/or change in the medication during the study period.

Treatment and study plan

• Blended treatment for AjD combining a self-applied Internet-based program (TAO) with face-to-face sessions via videoconference.

Behavioral

The self-applied Internet-based program called TAO is accessible online from the platform https://psicologiaytecnologia.labpsitec.es. It is organised into 7 sequential modules of approximately 60 minutes. The patient will do a treatment module every 10-12 days, plus an individual session via videoconference with a therapist (approximately 20-30 minutes long). During these sessions, the therapist will explain the main contents of each module, resolve doubts and motivate the patient to continue with the therapy. It takes about 12 weeks to complete the intervention.

TAO is the optimised version of the original intervention protocol for AjD developed by Botella et al. by Botella et al. (2008) and includes the following therapeutic components: psychoeducation, emotion regulation techniques, exposure, problem-solving techniques, Mindfulness, acceptance and elaboration of the stressful event, positive psychology strategies and relapse prevention.

Primary outcomes

  1. Participants' adherence to the intervention.

    Time frame: At post-treatment (approximately 12 weeks from the beginning).

    Drop-outs rates (and reasons), number of modules completed, number of times participants enter treatment, time spent in treatment and whether they do reviews.

  2. Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    This questionnaire consists of two different scales. Both include 6 items with a response scale ranging from 0 (not at all) to 10 (completely). One of the scales refers to the expectations about the treatment and it is administered before starting the treatment once an explanation about it has been carried out. The other scale refers to the patients' opinion once they have finished the intervention.

  3. Opinion Questionnaire about the intervention

    Time frame: At post-treatment (approximately 12 weeks from the beginning).

    It assesses participants' opinion about TAO online program, the videoconference sessions with the therapist and the blended format. The questions refer to the satisfaction and usefulness of these components using a response scale from 0 to 10 and open-ended opinion questions.

  4. Working Alliance Inventory for guided Internet Interventions (WAI-I) adapted from Horvath and Greenberg (1989).

    Time frame: At post-treatment (approximately 12 weeks from the beginning).

    The WAI-I scale assesses the different components of therapeutic alliance according to Bordin (1979). This version is adapted for internet-based treatments and consists of 12 items with a response scale from 1 (never) to 7 (always).

  5. Usability System Scale (SUS; Bangor et al., 2008; Brooke,1996).

    Time frame: At post-treatment (approximately 12 weeks from the beginning).

    This scale assesses the usability of a service or product and the acceptance by the users. It consists of 10 items with a response scale ranging from 1 (strongly disagree) to 5 (strongly agree).

Secondary outcomes

  1. Change in Adjustment Disorder New Module-20 (ADNM-20; Einsle et al., 2010).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    Self-report based on ICD-11 diagnostic criteria for AjD. It includes a list of stressful events and another of symptoms. Patients' symptomatology is evaluated in reference to the stressful event that they consider most interferes with them. It uses a response scale from 1 (never) to 4 (frequently). Higher scores indicate greater symptomatology. Lorenz et al. (2016) suggest that a cut off at 47.5 can differentiate between people with low and high risk of AjD.

  2. Change in the Loss and Stress Inventory (IEP) (Quero et al., 2019).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    The IEP consists of 17 items that assess the intensity with which a situation or person lost as a result of the stressful event interferes with the patient's life. It uses a response scale from 0 (never) to 4 (always).

  3. Change in the Positive and Negative Affect Scale (PANAS trait) (Watson et al., 1988; Díaz-García et al., 2020).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    The PANAS assesses two dimensions of mood (positive affect and negative affect). It consists of 20 items describing different emotions or feelings. The patient must respond to the extent to which he or she usually feels the way each expression, using a response scale from 1 (not at all or hardly at all) to 5 (very much).

  4. Change in the Posttraumatic Growth Inventory (PTGI) (Tadeschi and Calhoun,1996; Weiss et al., 2006).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    This measure includes 21 items that assess positive psychological change following an adverse or traumatic experience. It uses a response scale ranging from 0 (I did not experience this change as a result of the crisis) to 5 (I experienced this change to a great extent).

  5. Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Norman et al., 2006; González-Robles et al., 2018).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    The OASIS measures the frequency and severity of anxiety symptoms, as well as the degree of avoidance and interference. It consists of 5 items with a response scale from 0 to 4. Higher scores indicate greater severity or frequency of symptomatology.

  6. Change in the Overall Depression Severity and Impairment Scale (ODSIS; Norman et al., 2006; Mira et al., 2019).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    The ODSIS measures the frequency and severity of depressive symptoms, as well as the degree of avoidance and interference. It consists of 5 items with a response scale from 0 to 4. One additional item has been included to assess suicide ideation. Higher scores indicate greater severity or frequency of symptomatology.

Other outcomes

  1. Change in efficacy measures after each treatment module.

    Time frame: After each treatment module (i.e. 7 times) for approximately 12 weeks.

    First, patients answer questions about their mood. They are asked to select the face with the emotional expression that best reflects how they are feeling at that moment. Then, they are presented with a list of emotions and must indicate the extent to which they feel each emotion using a scale ranging from "not at all" to "totally". Finally, they are asked how they feel at the end of the module compared to how they felt before they started it. After these questions, changes in self-efficacy, acceptance of the stressful event, openness to future experiences and satisfaction with the module are assessed using a response scale from 0 to 10.

  2. Change in the Purpose-in-Life Test-10 Items (PIL-10) (Crumbaugh and Maholick, 1964; García-Alandete et al., 2013).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    This 10-item instrument assesses different aspects of meaning in life. It uses a response scale from 1 to 7, with higher scores indicating greater meaning of life.

  3. Change in the Quality of Life Inventory (QLI) (Mezzich et al., 1986; Mezzich et al., 2000).

    Time frame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).

    This measure includes 10 items that assess patients' quality of life in different areas and globally. It uses a response scale from 1 (poor) to 10 (excellent).

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Registry information

Official study title

A Blended Intervention for Adjustment Disorder: Feasibility Trial and Preliminary Effectiveness.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2022
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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