Evidence-Based Psychological Treatment for Emotional Disorders Attended in Dominican Primary Care Units (PsicAP)

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Treatment for Emotional Disorders in Primary Care Units With Evidence-Based Psychological Techniques and mHealth: A Randomized Controlled Trial

ClinicalTrials.gov ID

NCT04642092

Acronym / sponsor ID

PsicAP / 2018-2019-2A1-96

Conditions

Anxiety Disorders, Depression, Somatic Disorders, Emotional Disorder

Keywords

Cognitive Behavioral Therapy, Primary Care, Emotional Disorders

Study type

Interventional

Recruitment status

Unknown status

Enrolment

300 participants (estimated)

Lead sponsor

Pontificia Universidad Catolica Madre y MaestraUniversity, hospital or other

Collaborators

Ministerio de Educación Superior, Ciencia y Tecnología, Dominican Republic

Study start

9 Aug 2021 (actual)

Primary completion

May 2023 (estimated)

Study completion

May 2023 (estimated)

First posted

24 Nov 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (participant, care provider)

Number of arms

2

Who may qualify

Ages

18 to 79 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change in the score of Patient Health Questionnaire-2

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   On Patient Health Questionnaire-2 (PHQ-2), patients are asked how often, in the last two weeks, they have been bothered by depressed mood and anhedonia. Each response option is scored from 0 to 3. Therefore, total scores of the scale range from 0 to 6. A score of 3 or greater means high possibility of major depressive disorder.

2. Change in the score of Patient Health Questionnaire-4

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   On Patient Health Questionnaire-4 (PHQ-4), subjects are asked how often, in the last two weeks, they have been bothered by core symptoms/signs of depression and anxiety. This test has two subscales: one of them has two items that evaluate depression; the other one, two items that assess anxiety. Each response option is scored from 0 to 3, so total scores for each subscale range from 0 to 6. A score of 3 or greater on the depression subscale represents a high probability of this disease; a score of 3 or greater on the anxiety subscale means that the prevalence of an anxiety disorder is likely.

3. Change in the score of Patient Health Questionnaire-9

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   On Patient Health Questionnaire-9 (PHQ-9), through 9 items, subjects are asked how often, in the last two weeks, they have been bothered by core symptoms of depression. Each response option is scored from 0 to 3, so total scores range from 0 to 27. PHQ-9 scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively.

4. Change in the score of Patient Health Questionnaire-15

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   On Patient Health Questionnaire-15 (PHQ-15), through 15 items, subjects are asked how often, in the last 4 weeks, they have been bothered by somatic symptoms. Each response option is scored from 0 to 2. Therefore, total scores range from 0 to 30. PHQ-15 scores of 5, 10, 15, represent cutpoints for low, medium, and high somatic symptom severity, respectively.

5. Change in the score of Patient Health Questionnaire-PD

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   The Patient Health Questionnaire-Panic Disorder (PHQ-PD) is actually a section of PHQ, which comprises 15 items (questions 3a-d and 4a-d-k are the ones that evaluate PD). There are two answer categories: "no" (0 points) and "yes" (1 point.). Therefore, total scores range from 0 to 15. In Spanish population, the best cutoff score for screening panic disorder in patients is 5.

6. Change in the score of Generalized Anxiety Disorder Test-2

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   On Generalized Anxiety Disorder Test (GAD-2), through two items, subjects are asked how often, in the last two weeks, they have been bothered by core symptoms of anxiety. Each response option of the scale is scored from 0 to 3, so total scores range from 0 to 6. GAD-2 score of 3 represent the best cutoff point for screening generalized anxiety disorder.

7. Change in the score of Generalized Anxiety Disorder Test-7

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   On Generalized Anxiety Disorder Test-7 (GAD-7), through seven items, subjects are asked how often, in the last two weeks, they have been bothered by core symptoms of generalized anxiety disorder. Each response option of the scale is scored from 0 to 3, so total scores range from 0 to 21. Scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively.

8. Change in the score of Sheehan Disability Inventory

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   The Sheehan Disability Inventory (SDS) is a 5-item self-report tool. In the first three items, patients rate their functional impairment in work/school, social life, and family life, by a 10-point visual analog scale in each case. Scores of ≥5 on any of the three scales are associated with significant functional impairment. The last two items evaluate the amount of days lost or unproductive due to the functional impairment.

9. Change in the score of the Brooding subscale from Ruminative Responses Scale (RRS)

   Time frame: An average of 16 months (from baseline to psychological treatment completion).

   The Ruminative Responses Scale (RRS) has 22 items. Patients must indicate what they generally do when they feel down, sad, or depressed, using a 4-point Likert-type scale representing frequency (1=never; 4=always). The brooding subscale is composed by 5 of the 22 items of the whole scale. Therefore, total scores of this subscale range from 5 to 20. Higher scores on this subscale indicate significant levels of brooding.

10. Change in the score of the Penn State Worry Questionnaire (PSWQ)

    Time frame: An average of 16 months (from baseline to psychological treatment completion).

    The Penn State Worry Questionnaire (PSWQ) is a 16-item questionnaire. Items are rated using a 5-point Likert-scale (from 1="not at all typical of me" to 5="very typical of me"). Therefore, total scores range from 16 to 80. Scores of ≥16, ≥40, and ≥60 represent low, moderate, and high worry levels, respectively.

11. Change in the score of Inventory of Cognitive Activity in Anxiety Disorders

    Time frame: An average of 16 months (from baseline to psychological treatment completion).

    Inventory of Cognitive Activity in Anxiety Disorders (IACTA; Inventario de Actividad Cognitiva en los Trastornos de Ansiedad) is an instrument that evaluates certain cognitive activity in patients with different types of anxiety disorders. It has three subscales: panic attack (14 items), agoraphobia (14 items), and social phobia (20 items). Subjects are asked to indicate how often they pay attention to certain cognitive distortions about symptoms related to those disorders, ranging from 0 (almost never) to 4 (almost always). Higher the scores, higher the probability of suffering from a type of anxiety disorder. A cutoff point of 48 on panic attack and agoraphobia subscales was related to the prevalence of panic disorder; a cutoff point of social phobia subscale was related to suffering from social phobia disorder.

12. Change in the score of Questionnaire of Cognitive Distorsions in Emotional Disorders

    Time frame: An average of 16 months (from baseline to psychological treatment completion).

    Questionnaire of Cognitive Distorsions in Emotional Disorders (CDTE; Cuestionario de Distorsiones Cognitivas en los Trastornos Emocionales) is an instrument that evaluates the frequency with which certain cognitive distortions appear. It has 52 items. Each response option of the scale is scored from 0 (almost never) to 4 (almost always). Therefore, total scores range from 0 to 208. Higher scores indicate greater levels of cognitive distortions.

13. Change in the score of Emotion Regulation Questionnaire (ERQ)

    Time frame: An average of 16 months (from baseline to psychological treatment completion).

    Emotion Regulation Questionnaire (ERQ) is a 10-item scale that measures patients' tendency to regulate their emotions in two ways: cognitive reappraisal and expressive suppression. Each response option is scored by a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Therefore, total scores range from 10 to 70. The higher the score, the greater the use of emotion regulation strategies.

14. Change in the score of Metacognitions Questionnaire (MCQ-30)

    Time frame: An average of 16 months (from baseline to psychological treatment completion).

    Metacognitions Questionnaire (MCQ-30) measures individual differences in meta-cognitive beliefs, judgments and monitoring tendencies. It comprises a total of 30 items. Responses to each item are based on a 4-point Likert scale (from 1 = "do not agree" to 4 = "strongly agree"). MCQ-30 scores range from 30 to 120 points. Higher scores indicate greater pathological meta-cognitive activity.

15. Change in the score of World Health Organization Quality of Life - BREF (WHOQOL-BREF)

    Time frame: An average of 16 months (from baseline to psychological treatment completion).

    The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire that evaluates four domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. In addition, there are two items that measure overall QOL and general health. The whole scale is formed by 26 items. Subjects have to answer according to how they have been feeling in the last two weeks. Responses to each item are based on a 5-point Likert scale (from 1 = "not at all" to 5 = "completely"). The raw score ranges of each domain are: 7-35 for physical health, 6-30 for psychological health, 3-15 for social relationships, and 8-40 for environment. Higher scores denote higher quality of life.

16. Change in the score of EuroQol-5 D (EQ-5D)

    Time frame: An average of 16 months (from baseline to psychological treatment completion).

    EuroQoL is an instrument that measure the quality of life related to health. It has two main parts. The first part is a descriptive system in which subjects indicate how they feel, during the current day of the assessment, in the following areas of their lives: movement ability, personal care, daily activities, pain and anxiety/depression. Responses to each item are based on three options: 1 (no problems), 2 (some/moderate problems), 3 (many problems). Higher scores on these items denote worse quality of life. The second part is a visual analog scale in which subjects must indicate how they evaluate their health condition during the current day of the evaluation (from 0=the worst health condition, to 100=the best health condition).

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
• BackgroundCano Vindel A. Bases teóricas y apoyo empírico de la intervención psicológica sobre los desórdenes emocionales en Atención Primaria. Una actualización. Ansiedad y estrés. 2011; 17(2-3): 157-184.
• Derived from this study: PubMed 37226144Garcia-Batista ZE, Cantisano-Guzman LM, Guerra-Pena K, Alvarez A, Moretti L, Cano-Vindel A, Munoz-Navarro R, Medrano LA, Baltra RA. PsicAP transdiagnostic protocol of group cognitive-behavioral training for emotional disorders in Dominican Republic: a randomized controlled trial protocol. BMC Psychiatry. 2023 May 24;23(1):363. doi: 10.1186/s12888-023-04771-3.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

4 sites in 1 country: see every site and its status.