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

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

Study Description

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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Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Concepción Fernández-Rodríguez; +34 985 10 32 49; frconcha@uniovi.es

Contact: Rocío Coto-Lesmes; 682247998; UO193925@uniovi.es

Locations

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

More Information

• 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
• 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)

• 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:

Depression; Behavioral Symptoms