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Psychotherapy for Young Adults With Mild-to-moderate Depression: Does Virtual Reality Increase Its Efficacy (PSYADEP)

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ClinicalTrials.gov Identifier: NCT04321525
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : May 16, 2023
Universitat Oberta de Catalunya
Information provided by (Responsible Party):
Dr. Guillem Feixas, University of Barcelona

Brief Summary:

Cognitive Behavioral Therapy (CBT) is the most prestigious psychological treatment for depression. However, not only do we need to increase its efficacy but also to widen the repertoire of evidence-based psychotherapeutic interventions. The importance of the patient's engagement in treatment is highlighted in the literature as a key factor for a good therapeutic outcome over and above the type of therapy. In this sense, personal construct therapy (PCT), with some promising supporting evidence, is particularly suited to fit the personal values and attitudes of each patient. In contrast to CBT, PCT does not educate patients about depression and give them directions on the changes to be made in their dysfunctional behaviors or cognitions. Rather, PCT explores their coherence with respect to the person's sense of identity, their construction of self and others, and works with the conflicts or dilemmas that appear during this conjoint exploration using the Repertory Grid Technique (RGT). In this project, for the first time, the RGT will be implemented using Virtual Reality (VR). This format could be highly appealing for young people, thus facilitating their involvement in therapy. The efficacy of this innovative application of PCT using VR (PCT-VR) will be compared to usual PCT, and to CBT in a randomized clinical trial. The Beck Depression Inventory-II is the primary outcome measure for calculating both statistical and clinical significance, but other measures will also be used at pre-, post-therapy and six-month follow up. The trial will be done in a natural health context, mostly the usual primary care center of each patient, with those who consult during the active period of the study.

Our research group has been working on both depression and personal construct theory for more than two decades (this includes our previous funded projects), particularly with a dilemma-focused intervention aimed to resolve the cognitive conflicts detected with the RGT. By fostering a technological innovation with VR, it is expected to boost the current efficacy of psychotherapy by increasing the engagement of young people and obtaining better outcomes. If these goals are met, a pathological evolution of the patient with its associated personal, health and social costs could be avoided.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive-behavioral therapy Behavioral: Personal Construct Therapy Behavioral: Personal Construct Therapy with virtual reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychotherapy for Young Adults With Mild-to-moderate Depression: Does Virtual Reality Increase Its Efficacy
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Cognitive-behavioral therapy (CBT)
Individual Cognitive Behavioral Therapy
Behavioral: Cognitive-behavioral therapy
10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
Other Name: Cognitive therapy

Experimental: Personal construct therapy (PCT)
Individual Personal Construct Therapy
Behavioral: Personal Construct Therapy
10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session

Experimental: Personal construct therapy with virtual reality (PCT-VR)
Individual Personal Construct Therapy with an immersive virtual reality app
Behavioral: Personal Construct Therapy with virtual reality
10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session

Primary Outcome Measures :
  1. Change in Beck depression inventory second edition [ Time Frame: BDI-II is administered at the end of therapy (10 weeks), and 6-month follow-up ]
    Beck Depression Inventory, Second Edition (BDI-II; Beck, Steer & Brown, 1996). It is a 21-item self-report instrument to assess the existence and severity of symptoms of depression. Both the original and the Spanish version (Sanz, Perdigón, & Vázquez, 2003) showed good psychometric properties and acceptability.

Secondary Outcome Measures :
  1. Clinical Outcomes in Routine Evaluation-Outcome Measure [ Time Frame: CORE-OM is administered at baseline, and then routinely every session (using short forms versions A and B) until the end of treatment (10 weeks), and 6-month follow-up ]
    Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM; Evans et al, 2002). It is a 34-item self-report questionnaire for the assessment of subjective wellbeing, symptoms or problems, life functioning and risk. It has good psychometric properties (Trujillo et al, 2016) and it has been adapted into Spanish for free distribution (www.ub.edu/terdep/core) . The short version (CORE-SFB) of 18 items will be used for session-to-session monitoring of the therapy process.

  2. - Depression, Anxiety and Stress Scales [ Time Frame: DASS-21 is administered at the end of therapy (10 weeks), and 6-month follow-up ]
    Depression, Anxiety and Stress Scales (DASS-21; Lovibond & Lovibond, 1995). This 21-item version of the DASS comprises 7 items for its three scales (depression, anxiety and stress) which are moderately correlated with each other. The scores for each scale range from 0 to 21. There have been studies of validation with Spanish population finding satisfactory psychometric properties (Bados, Solanas, & Andrés, 2005).

  3. Session Rating Scale 3.0 [ Time Frame: SRS 3.0 is administered routinely after every session, through intervention completion (10 weeks), and 6-month follow-up ]
    Session Rating Scale 3.0 (SRS 3.0; Duncan et al., 2003). It is a brief questionnaire designed to assess therapeutic alliance at the end of the session. It is composed of 4 items that have to be answered through a visual analog scale (VAS) of 10 centimeters. They measure the appreciation of the relationship with the therapist, agreement with the therapist about the goals and issues discussed in the session, agreement with the method or approach of the therapist, and global assessment of the session. The Spanish version obtained good levels of validity and reliability (Moggia, Niño-Robles, Miller, & Feixas, 2018)

  4. Change Interview [ Time Frame: administered at the end of therapy (10 weeks) ]
    Change Interview (Elliott, Slatick and Urman, 2001). This semi-structured interview was created to assess the changes produced throughout therapy, the useful aspects, and the adverse effects of interventions from the patient's perspective. The patient is asked about the (positive) changes he/she has experienced with the intervention, as well as the negative changes if there has been any. Questions are also asked about the attribution of such changes, and their probability of occurrence without intervention. Its functions in this study are to identify both changes that patients are aware of (in their own words) which might go unnoticed with standardized questionnaires and adverse effects (too often neglected in psychotherapy research).

Other Outcome Measures:
  1. Treatment adherence scale [ Time Frame: Administered at the end of therapy (up to 1 year) ]
    The Adherence to protocol scale created in a preliminary study will be used for assessing the adherence of therapists to the protocols of the assigned treatment condition. The higher the score the better the adherence in a scale from zero to ten. Two graduate students blinded to the treatment conditions and trained to use the scale reliably will rate the audiotapes of 10 sessions of CBT, PCT and PCT-VR.

  2. Consumer Reports Effectiveness Scale [ Time Frame: administered at the end of therapy (10 weeks) ]
    Consumer Reports Effectiveness Scale (CRES-4 Feixas, Pucurull, Roca, Paz, García-Grau y Bados, 2012). It consists of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. The total score is intended to reflect the degree of satisfaction with treatment received. To interpret CRES-4 globally, a score is considered that is on a scale ranging from 0 to 300 points. The higher the total score, the greater the effectiveness of the treatment according to the patient.

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All participants will meet diagnostic criteria for mild or moderate depressive episode according to ICD-10 (current version in the Catalan health system), diagnosed using MINI, and a score above 13 and below 29 on the BDI-II questionnaire.

Exclusion Criteria:

  • Patients presenting bipolar or other affective disorders (ICD-10), psychotic symptoms, substance abuse, organic brain dysfunction, acute suicidal ideation or mental retardation will be excluded from the study. The presence of other comorbid conditions (anxiety, eating or personality disorders, etc.) will not be cause for exclusion but they will be assessed and recorded and explored statistically. Finally, those who do not have enough level of competence to communicate in Spanish or Catalan, or patients with substantial visual, hearing and cognitive deficits cannot be included

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321525

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Contact: Guillem Feixas, Ph.D 0034933125100 gfeixas@ub.edu
Contact: Adrian Montesano, Ph.D 0034934505225 amontesano@uoc.edu

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Hospital de Mataró Recruiting
Mataró, Barcelona, Spain, 08304
Contact: José Cañete, MD         
University of Barcelona Not yet recruiting
Barcelona, Catalonia, Spain, 08035
Contact: Guillem Feixas, Ph.D.    +34933125809    gfeixas@ub.edu   
Contact: Adrián Montesano, Ph.D.    +34934505225    amontesano@uoc.edu   
Principal Investigator: Guillem Feixas, Ph.D.         
Principal Investigator: Adrián Montesano, Ph.D.         
Associació Centre Higiene Mental Nou Barris Recruiting
Barcelona, Spain, 08042
Contact: Giusi Rametti         
Sponsors and Collaborators
University of Barcelona
Universitat Oberta de Catalunya
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Principal Investigator: Guillem Feixas, Ph.D University of Barcelona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Guillem Feixas, full professor, University of Barcelona
ClinicalTrials.gov Identifier: NCT04321525    
Other Study ID Numbers: RTI2018-094294-B-I00
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data for all primary and secondary outcomes, after deidentification
Supporting Materials: Study Protocol
Time Frame: Data will be available after six months of study completion
Access Criteria: Researchers who provide a methodologically sound proposal whose proposed use of the data has been approved by an independent review committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders