Clinical trial NCT05464121: A Blended Intervention for Adjustment Disorder.
Official title: A Blended Intervention for Adjustment Disorder: Feasibility Trial and Preliminary Effectiveness.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adjustment Disorders
Keywords: Adjustment Disorders
Internet-based treatment
Blended intervention
Feasibility
Videoconferencing
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be assessed for eligibility and if they meet the inclusion criteria they will be assigned to the single treatment group (single arm). All patients will receive the same blended intervention that combines the self-applied online TAO program with videoconferencing sessions with a therapist.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants' adherence to the intervention.
timeFrame: At post-treatment (approximately 12 weeks from the beginning).
measure: Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
measure: Opinion Questionnaire about the intervention
timeFrame: At post-treatment (approximately 12 weeks from the beginning).
measure: Working Alliance Inventory for guided Internet Interventions (WAI-I) adapted from Horvath and Greenberg (1989).
timeFrame: At post-treatment (approximately 12 weeks from the beginning).
measure: Usability System Scale (SUS; Bangor et al., 2008; Brooke,1996).
timeFrame: At post-treatment (approximately 12 weeks from the beginning).
Secondary outcomes:
measure: Change in Adjustment Disorder New Module-20 (ADNM-20; Einsle et al., 2010).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
measure: Change in the Loss and Stress Inventory (IEP) (Quero et al., 2019).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
measure: Change in the Positive and Negative Affect Scale (PANAS trait) (Watson et al., 1988; Díaz-García et al., 2020).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
measure: Change in the Posttraumatic Growth Inventory (PTGI) (Tadeschi and Calhoun,1996; Weiss et al., 2006).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
measure: Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Norman et al., 2006; González-Robles et al., 2018).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
measure: Change in the Overall Depression Severity and Impairment Scale (ODSIS; Norman et al., 2006; Mira et al., 2019).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
Other outcomes:
measure: Change in efficacy measures after each treatment module.
timeFrame: After each treatment module (i.e. 7 times) for approximately 12 weeks.
measure: Change in the Purpose-in-Life Test-10 Items (PIL-10) (Crumbaugh and Maholick, 1964; García-Alandete et al., 2013).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
measure: Change in the Quality of Life Inventory (QLI) (Mezzich et al., 1986; Mezzich et al., 2000).
timeFrame: At pre-treatment (before starting the intervention), at post-treatment (approximately 12 weeks from the beginning), and follow-ups (3 and 12 months).
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
affiliation: Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
name: Soledad Quero, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
name: Pim Cuijpers, Ph.D
role: STUDY_DIRECTOR
affiliation: Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
name: Sara Fernández Buendía, Ph.D student
role: STUDY_CHAIR
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