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Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders (TRANSACTIVA)

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ClinicalTrials.gov Identifier: NCT04117464
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Concepción Fernández-Rodríguez, University of Oviedo

Brief Summary:
This study aims to investigate the efficacy of three psychotherapeutic programs in group format: Acceptance and Commitment Therapy (ACT), Behavioral Activation (AC) and Transdiagnostic Cognitive Behavioral Therapy (TD-CBT), for the treatment of emotional disorders. Considering the data of the literature and the results of previous research, it is expected that this clinical investigation shows that transdiagnostic interventions that are tested (AC, ACT, TD-CBT) cause clinical changes in the post-treatment. However, it is expected that in post-treatment and in the short and medium-term follow-up, significant differences will be found between the transdiagnostic therapies examined in all outcome criteria variables; and that the greatest effectiveness and effectiveness be achieved in contextual therapies, in particular, in Behavioral Activation therapy. It is expected that the study design will allow obtaining firm evidence of the active therapeutic ingredients from the analysis of the differential efficacy of each of the psychotherapeutic programs. As a final consequence and based on the results and discussion on transdiagnostic conditions and transtherapeutic elements, it is expected to develop a unified treatment protocol (in group format -as an efficient work format and appropriate to the needs of public health services-) to be easily applied in the field of primary care. It could facilitate access to effective treatment of common mental disorders in public health services.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Behavioral activation therapy Behavioral: Acceptance and Commitment Therapy Behavioral: Cognitive-Behavioral Therapy Other: Wait List Group Not Applicable

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Detailed Description:

This study aims to investigate the efficacy of three psychotherapeutic programs in group format: Acceptance and Commitment Therapy (ACT), Behavioral Activation (AC) and Transdiagnostic Cognitive Behavioral Therapy (TD-CBT), for the treatment of emotional disorders. Considering the data of the literature and the results of previous research, it is expected that this clinical investigation shows that transdiagnostic interventions that are tested (AC, ACT, TD-CBT) cause clinical changes in the post-treatment. However, it is expected that in post-treatment and in the short and medium term follow-up, significant differences will be found between the transdiagnostic therapies examined in all outcome criteria variables; and that the greatest effectiveness and effectiveness be achieved in contextual therapies, in particular, in Behavioral Activation therapy. It is expected that the study design will allow obtaining firm evidence of the active therapeutic ingredients from the analysis of the differential efficacy of each of the psychotherapeutic programs. As a final consequence and based on the results and discussion on transdiagnostic conditions and transtherapeutic elements, it is expected to develop a unified treatment protocol (in group format -as an efficient work format and appropriate to the needs of public health services-) to be easily applied in the field of primary care. It could facilitate access to effective treatment of common mental disorders in public health services.

The present investigation has as general objectives:

  1. Establish the effectiveness, effectiveness and efficiency of Behavioral Activation (AC), Acceptance and Commitment (ACT) and Transdiagnostic Cognitive-Behavioral (TD-CBT) therapy applied in group format for the treatment of emotional disorders in the context of Primary Care.
  2. Analyze the differential utility and adequacy of contextual transdiagnostic therapy (AC; ACT) and cognitive behavioral therapy (TD-CBT) according to clinical conditions of the disorder, characteristics of the subjects and of the therapeutic procedure and the transdiagnostic assumptions that define them.
  3. Develop a unified treatment protocol for emotional disorders for implementation in primary care.

Specific objectives are:

  1. Identify patterns of psychological inflexibility (experiential avoidance; activation and cognitive fusion) and cognitive biases in people with emotional disorders (anxiety and / or depression).
  2. To assess the efficacy, effectiveness and efficiency of three transdiagnostic therapies (AC, ACT, and TD-CBT) applied in group format for the treatment of emotional disorders, analyzing the evolution of the outcome criteria defined in relation to emotional state and functionality of the patients assigned to each experimental treatment condition and in relation to a waiting list condition.
  3. Assess the adequacy and specificity of AC, ACT and TD-CBT in the treatment of emotional disorders according to different conditions: patient's clinical state, characteristics of the context and the therapeutic procedure defined as outcome criteria variables.
  4. Identify the active therapeutic ingredients of the therapies on the results of the efficacy, effectiveness and adequacy of the interventions.
  5. Develop a Unified Treatment Protocol to facilitate the implementation of an efficacious and effective intervention of emotional disorders in public health institutions, especially in the context of Primary Care.
  6. Maintain a website to disseminate information to general population regarding services provided in the context of this research project and to share experiences with other professionals and researchers.

The sample will be composed by patients who obtain a score that indicates clinically significant symptoms according to the Hospital Anxiety and Depression Scale (HADS, Zigmond and Snaith, 1983). All participants have to sign the informed consent after being informed about the objectives and procedure of the study.

Participants that meet inclusion criteria will be randomly assigned to the experimental and control conditions. The programs will be developed in group format (maximum 8 patients / group) and will be implemented consecutively until reaching the required sample size.

Preselected patients will be interviewed by one of the researchers. The investigator explains the objectives and procedures and then participants sign the informed consent document and answer the Hospital Anxiety and Depression Scale (HADS, Zigmond and Snaith, 1983). When the result indicates clinically significant symptoms, participants will be randomly assigned (according to the table of numbers) to one of the different conditions of the investigation: three experimental (ACT; AC; TD-TCC) and a control (WL). Next, participants will be cited for an individual evaluation session in which the study variables will be explored through clinical interview and scales. After the individual evaluation session, experimental groups will receive 8 group psychotherapy sessions specific to each condition. Then, each patient have follow ups at 3, 6, 9 and 12 months after finishing the therapeutic group.

Wait List group will be evaluated after the same period of time of the experimental groups and with the same procedure. Subsequently, participants will be offered the possibility of receiving the intervention that has been shown to be most effective and / or suitable according to their peculiarities.

Therapy was administered by two licensed clinical psychologists. In order to ensure adhesion of clinical psychologists to therapeutic protocols, the intervention sessions were audio-recorded and weekly supervision sessions by the principal investigator of study were held. In addition, regular peer-to-peer coaching and supervision meetings were held to ensure protocol adherence.

Analysis of data:

The descriptive study of the sample and a study of the equivalence of control and experimental groups (with the relevant statistics according to the type of variable) will be carried out.

The investigators will study patients evolution and compare experimental and control groups in all variables using inferential statistics and evaluate the clinical change at experimental groups. For the statistical analysis a database and the statistical program IBM SPSS will be used.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are simple randomized to three experimental conditions (Behavioral activation, Acceptance and commitment therapy and Cognitive-behavior therapy) and a Wait List control group
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Contextual Therapies (Behavioral Activation and Acceptance and Commitment Therapy) and Cognitive Behavioral Therapy (CBT) in Group Format as a Transdiagnostic Intervention in Emotional Disorders.
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Behavioral activation therapy
Behavioral activation therapy was applied following the protocol designed by Martell, Dimidjian & Herman-Dunn (2013).
Behavioral: Behavioral activation therapy
Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Other Name: BA

Experimental: Acceptance and Commitment Therapy
Acceptance and Commitment therapy was applied following the protocol designed by Hayes, Strosahl & Wilson, (2011).
Behavioral: Acceptance and Commitment Therapy
Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Other Name: ACT

Experimental: Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy was applied following the protocol designed by Barlow, Allen and Choate (2004).
Behavioral: Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Other Name: CBT

Wait List Group
Participants at Wait List Group will be evaluated pre-post and 3, 6, 9 and 12 months follow up periods, like experimental groups.
Other: Wait List Group
No psychological intervention
Other Name: Control Group




Primary Outcome Measures :
  1. Change at Depression subscale (7 items of HADS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    frequency and intensity of depression symptoms measured by Hospital Anxiety and Depression Scale (HADS), 7 items of depression subscale

  2. Change at Anxiety subscale (7 items of HADS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    frequency and intensity of anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS), 7 items of anxiety subscale


Secondary Outcome Measures :
  1. Change at Depression scale (BDI-IA-SCA) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    frequency and intensity of depression symptoms measured by Short form of the Beck Depression Inventory based on the cognitive-affective subscale (BDI-IA-SCA)

  2. Change at General Anxiety scale (GAD-7) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    frequency and intensity of anxiety symptoms measured by General Anxiety Disorder Scale (GAD-7)

  3. Change at Psychological Inflexibility scale (AAQ-II) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Change at psychological inflexibility measured by Acceptance & Action Questionnaire (AAQ-II)

  4. Change at Behavioral activation subscale (7 items of BADS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Behavioral activation pattern measured by 7 items of Behavioral Activation for Depression Scale (BADS) activation subscale

  5. Change at Experiential avoidance subscale (8 items of BADS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Experiential avoidance pattern measured by 8 items of Behavioral Activation for Depression Scale (BADS) avoidance subscale

  6. Change at Work impairment subscale (5 items of BADS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Degree of Work impairment measured by 5 items of Behavioral Activation for Depression Scale (BADS) work impairment subscale

  7. Change at Social impairment (5 items of BADS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Degree of Social impairment measured by 5 items of Behavioral Activation for Depression Scale (BADS) social impairment subscale

  8. Change at Cognitive fusion scale (CFQ) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Cognitive fusion pattern measured by Cognitive Fusion Questionnaire (CFQ)

  9. Change at Quality of life Scale (WHOQOL-BREF) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    General Quality of life measured by WHOQOL-BREF questionnaire

  10. Change at Physical Health subscale (7 items of WHOQOL-BREF) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest and Work Capacity measured by 7 items of WHOQOL-BREF questionnaire

  11. Change at Psychological Health subscale (6 items of WHOQOL-BREF) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Bodily image and appearance, Positive and Negative feelings, Self-esteem, Spirituality / Religion / Personal beliefs, Thinking, learning, memory and concentration, measured by 6 items of WHOQOL-BREF questionnaire

  12. Change at Social relationships subscale (3 items of WHOQOL-BREF) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Personal relationships, Social support and Sexual activity measured by 3 items of WHOQOL-BREF questionnaire

  13. Change at Environment subscale (8 items of WHOQOL-BREF) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Financial resources, Participation in and opportunities for recreation / leisure activities, Physical environment (pollution / noise / traffic / climate) measured by 8 items of WHOQOL-BREF questionnaire

  14. Change at Cognitive reappraisal subscale (6 items of ERQ) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Cognitive reappraisal measured by 6 items of Emotion Regulation Questionnaire (ERQ) Reappraisal subscale

  15. Change at Expressive suppression subscale (4 items of ERQ) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    expressive suppression measured by 4 items of Emotion Regulation Questionnaire (ERQ) suppression subscale

  16. Change at Positive environmental reinforcement scale (EROS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Positive environmental reinforcement perceived by the participant in recent weeks, measured by EROS (Environmental Reward Observation Scale)

  17. Patient satisfaction scale (CSQ-8) [ Time Frame: Post-treatment (after last session, after 8 weeks) ]
    Patient satisfaction measured by Client Satisfaction Questionnaire (CSQ-8)


Other Outcome Measures:
  1. Change at perceived anxiety (PVAS) [ Time Frame: At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks) ]
    Anxiety rated by the participant by a Patients Visual analog scale (PVAS)

  2. Change at perceived depression (PVAS) [ Time Frame: At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks) ]
    Depression rated by the participant by a Patients Visual analog scale (PVAS)

  3. Change at behavioral avoidance (PVAS) [ Time Frame: At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks) ]
    Behavioral avoidance rated by the participant by a Patients Visual analog scale (PVAS)

  4. Change at emotional avoidance (PVAS) [ Time Frame: At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks) ]
    Change at relevant activities maintenance by emotional avoidance rated by the participant by a Patients Visual analog scale (PVAS)

  5. Change at cognitive fusion (PVAS) [ Time Frame: At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks) ]
    Cognitive fusion rated by the participant by a Patients Visual analog scale (PVAS)

  6. Change at activation (PVAS) [ Time Frame: At the end of session 1 (after 1 week), session 2 (after 2 weeks), session 3 (after 3 weeks), session 4 (after 4 weeks), session 5 (after 5 weeks), session 6 (after 6 weeks), session 7 (after 7 weeks) and session 8 (after 8 weeks) ]
    Activation rated by the participant by a Patients Visual analog scale (PVAS)

  7. Self-registration techniques to asses patient adherence [ Time Frame: At session 2 (after 2 weeks), at session 3 (after 3 weeks), at session 4 (after 4 weeks), at session 5 (after 5 weeks), at session 6 (after 6 weeks), at session 7 (after 7 weeks) and at session 8 (after 8 weeks) ]
    Self-registers are used during treatment sessions (after 2, 3, 4, 5, 6, 7 and 8 weeks)

  8. Change at anxiety/irritability rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Anxiety rated by the clinician by a Clinician Visual analog scale (CVAS)

  9. Change at depression rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Depression rated by the clinician by a Clinician Visual analog scale (CVAS)

  10. Change at attention to the presente rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Attention to the present rated by the clinician by a Clinician Visual analog scale (CVAS)

  11. Change at experiential avoidance rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Experiential avoidance rated by the clinician by a Clinician Visual analog scale (CVAS)

  12. Change at emotional avoidance rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Change at relevant activities maintenance by emotional avoidance rated by the clinician by a Clinician Visual analog scale (CVAS)

  13. Change at rumination rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Change at relevant activities maintenance by rumination rated by the clinician by a Clinician Visual analog scale (CVAS)

  14. Change at cognitive fusion rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Change at relevant activities maintenance by cognitive fusion rated by the clinician by a Clinician Visual analog scale (CVAS)

  15. Change at behavioral avoidance rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Behavioral avoidance rated by the clinician by a Clinician Visual analog scale (CVAS)

  16. Change at activation rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Activation rated by the clinician by a Clinician Visual analog scale (CVAS)

  17. Change at Avoidance of relevant activities maintained by relatives rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Avoidance of relevant activities maintained by relatives rated by the clinician by a Clinician Visual analog scale (CVAS)

  18. Change at illness behavior maintained by relatives rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    illness Behavior maintained by relatives rated by the clinician by a Clinician Visual analog scale (CVAS)

  19. Change at Healthy behavior promoted by relatives rated by the clinician (CVAS) [ Time Frame: Pre-treatment, Post-treatment (after last session, after 8 weeks) and Follow ups (3, 6, 9 and 12 months) ]
    Healthy behavior promoted by relatives rated by the clinician by a Clinician Visual analog scale (CVAS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anxiety and/or depression (a score above the cutoff point in at least one of HADS subscales)
  • Willingness, availability and motivation to participate in a group therapy of 8 sessions.

Exclusion Criteria:

  • Being under another psychological treatment
  • Physical and / or cognitive deterioration that hinders participation in the therapeutic plan.
  • Serious illness that compromises patient's life and / or chronic cancer pain.

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): NCT04117464


Contacts
Layout table for location contacts
Contact: Concepción Fernández-Rodríguez +34 985 10 32 49 frconcha@uniovi.es
Contact: Rocío Coto-Lesmes 682247998 UO193925@uniovi.es

Locations
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Spain
University of Oviedo Recruiting
Oviedo, Asturias, Spain, 33003
Contact: Concepción Fernández-Rodríguez    +34 985 10 32 49    frconcha@uniovi.es   
Contact: Rocío Coto-Lesmes    682 24 79 98    UO193925@uniovi.es   
Principal Investigator: Rocío Coto-Lesmes         
Sponsors and Collaborators
University of Oviedo
Ministerio de Economía y Competitividad, Spain

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Responsible Party: Concepción Fernández-Rodríguez, Professor, University of Oviedo
ClinicalTrials.gov Identifier: NCT04117464     History of Changes
Other Study ID Numbers: FPU17/01181
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication are going to be share on an official data repository (Mendeley Data)
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Concepción Fernández-Rodríguez, University of Oviedo:
anxiety
depression
behavioral activation therapy
acceptance and commitment therapy
cognitive-behavioral therapy
transdiagnostic
group therapy
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms