Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

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.
    

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.
    

Intervention name(s): Behavioral activation therapy; Acceptance and Commitment Therapy; Cognitive-Behavioral Therapy; Wait List Group
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.; Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.; Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.; No psychological intervention
Other intervention name(s): BA; ACT; CBT; Control Group
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
Keywords: anxiety; depression; behavioral activation therapy; acceptance and commitment therapy; cognitive-behavioral therapy; transdiagnostic; group therapy