Depressive and Anxiety Disorders
Conditions
Keywords
Process Based Therapy, effectiveness
Brief summary
Background: Process Based Therapy (PBT) is a novel approach for a more personalized psychotherapy by integrating patient's ecological momentary assessment (EMA) data into treatment planning and focusing on empirically measured maladaptive processes. Previous pilot studies have examined the efficacy and feasibility of PBT in different settings. However, the effectiveness of this approach as well as the influence of providing EMA data on therapist's decision-making as well as treatment planning is yet unexplored. Objective: This study aims to evaluate the effectiveness of PBT in a naturalistic setting as well examine the influence of the provision of EMA data on therapists' decision-making. Methods: Thiry therapists as well as 60 patients will be recruited. Therapists will each treat two patients which are randomly allocated to either an intervention group receiving PBT or an active control group receiving routine psychotherapy. Treatment outcomes will be measured pre and post treatment as well as a 6-month follow-up. Therapists' decision making will be measured before training in PBT as well as during the treatment process using think aloud protocols (TAP) as well as quantitative measurements for decision making styles and self efficacy in decision making. Discussion: This study could add insights into the ongoing research about the efficacy and effectiveness of PBT as well as provide insights into therapists' treatment decisions. While PBT holds theoretical promise for a more personalized and effective treatment, empirical data is still needed to assess its theoretical merit, which this study could provide. Expanding on the thus far scarce literature on decision-making in the therapeutic process, valuable information about processes guiding therapists' treatment decisions could be gained.
Interventions
OTHERProcess Based Psychotherapy (PBT)
Intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.
OTHERRoutine practice
Intervention planning as usual.
DRUGPsychiatric medication kept constant over study duration
Psychiatric medication is kept constant during the trial. Participants are not required to take medication. If participants enlisting in the trial are on medication however, they will be asked to keep medication constant over the study duration
Sponsors
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A primary ICD-11 diagnosis of a depressive or anxiety disorder * Age 18-65 years * Sufficient knowledge of the German language * Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period
Exclusion criteria
* Increased suicidality * Substance abuse or dependency * diagnosis of a cluster A or B (DSM-5) personality disorder * pervasive developmental disorder, psychotic disorder, eating disorder, bipolar disorder, or severe physical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive and anxiety symptom severity | Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up. | To assess Psychopathological Stress , the Depression Anxiety Stress Scale 21 (DASS-21) is used. The DASS-21 is a validated and reliable 21 item self-report instrument for the measurement of depressive and anxiety symptoms. Additionally, stress as a negative affective state is measured on an additional subscale. The scale ranges from 1-4 with higher mean values reflecting higher symptom severity in the respective subscale as well as an overall score of Psychopathological Stress. |
| Positive Mental Health and Quality of Life | Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up. | Positive mental health and quality of Life will be measured using the positive mental health scale (PMH). The PMH is a validated nine-item self-report scale for the measurement of the presence of positive mental health. Scores range form 1-4 with higher mean scores reflecting a more positive mental health. |
| Therapist Decision Making | Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22). | Therapist Decision Making regarding treatment planning will be measured using think-aloud protocols (TAP). The think-aloud method is usually used to measure decision making in cognitive tasks such as problem solving, where participants are instructed to "think-aloud" meaning to verbalize their thoughts during a cognitive task. In this study, therapists will be instructed to verbalize their treatment planning at nine measurement points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client satisfaction | Assessed at post-treatment (week 28). | Patient satisfaction at the end of treatment, measured with the Client Satisfaction Questionnaire (CSQ). The CSQ uses 8 items with a range of 1-4 with higher mean values reflecting higher satisfaction with the recieved treatment. |
| Patient and Therapist Attitude Towards EMA-Assessment | Assessed at intermediate (week 6) and post-treatment (week 28) (PAUEN). Assessed at intermediate (week 6) and every four weeks in Treatment Phase (Weeks 10, 14, 18 and 22) (TAUEN) | the therapist attitudes toward the utility of the EMA and networks scale (TAUEN) and the patient attitudes toward the utility of the EMA and networks scale (PAUEN) are modified versions of the Therapist and Client Attitudes Measures. minimum value= 8, maximum value= 40, higher scores mean a higher attitude toward EMA and networks regarding their utility. |
| Therapist Treatment Evaluation | Assessed at intermediate (week 6) and every four weeks in the treatment phase (Weeks 10, 14, 18 and 22). | The Treatment Evaluation Inventory will be used to assess therapists' perceptions of treatment. It consists of 14 statements that are evaluated on a 7-point Likert scale, with response options spanning from -3 (strongly disagree) to +3 (strongly agree). A higher mean score reflects a higher attitude towards the given treatment (e.g. PBT or routine care) |
| Self-Efficacy | Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up. | Perceived general self-efficacy, meaning an optimistic self-belief that one can perform difficult or novel tasks or cope with adversity is measured by the General Self-Efficacy Scale (GSE). The GSE is a 10-item self-report questionnaire with a validated one factor structure. The GSE ranges from 1-4 with a higher mean score reflecting higher self-efficacy. |
| Decisional Self-Efficacy | Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate), assessed at post-treatment (week 28) and assessed at a six-month follow-up. | Decision making self-efficacy is measured using the Decision Self-Efficacy Scale. The DSE is an 11-item self-report instrument measuring self-efficacy in the domain of treatment decisions. The DSE ranges from 0-4 with higher mean scores reflecting a higher confidence and self-efficacy in treatment decisions. |
| Therapeutic Alliance | Assessed after randomization (Day 1), after completion of the EMA baseline phase (6-Week intermediate) and assessed at post-treatment (week 28). | Therapeutic Alliance is measured at patient level using the Working Alliance Inventory Short Revised Patient Version (WAI-SR-P). The WAI-SR-P measures therapeutic alliance from the patient's perspective using 12 items as a self report ranging from 1-5 with higher mean scores reflecting a stronger and more positive working alliance as perceived by the patient. |
| Therapist Decision Making Style | Assessed pre-training in PBT (Day 0), at Day 1 of treatment, after diagnosis (Day 2), after a hypothetical model is developed (Day 3), after EMA-Assessment is complete (Week-6) and every four weeks during the treatment phase (Weeks 10, 14, 18 and 22). | Therapists' Decision Making Styles will be measured using the therapist decision making questionnaire (TDMQ). The TDMQ is a self-report scale measuring therapists' decision-making style using 23 items on a scale from 1 to 5. Higher mean scores on a specific subscale reflect a decision style that puts a higher emphasis on the sources of information belonging to that specific decision making style. |
Countries
Germany
Contacts
CONTACTUlrich Stangier, PhD
PRINCIPAL_INVESTIGATORUlrich Stangier, PhD
Goethe Universität Frankfurt
Outcome results
None listed