University of Oviedo
Oviedo, Principality of Asturias, 33003, Spain
NCT Number: NCT04117464
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Oviedo, Principality of Asturias, 33003, Spain
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:
Specific objectives are:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Other names: BA
Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Other names: ACT
Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
Other names: CBT
No psychological intervention
Other names: Control Group
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
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
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)
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)
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)
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
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
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
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
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)
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
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
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
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
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
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
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
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)
Time frame: Post-treatment (after last session, after 8 weeks)
Patient satisfaction measured by Client Satisfaction Questionnaire (CSQ-8)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
University of Oviedo
Other
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.
Acronym: TRANSACTIVA
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