EFFECT-BACK: Tackling Back Pain - Effects of Exposure Therapy and Cognitive Behavioural Therapy for Chronic Back Pain
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: University of Kaiserslautern-Landau

Amendment EFFECT-BACK 
 
 
 
 
 
 
09.05.2025 
 
 
 
 
1. Title 
„BACK-2-EFFECT“: A 2-Year Follow-up of EFFects of Exposure and Cognitive-behavioural 
Therapy for chronic BACK pain 
 
2. Justification of amendment 
The current study investigates the comparative effectiveness of cognitive behavioral therapy 
and exposure therapy in the treatment of chronic back pain and focuses on the clinically 
significant improvement in pain-related impairment from baseline to 6-month follow-up. 
The aim of the 2-year catamnesis is to examine the sustainability of the treatment effects. For 
this purpose, a follow-up project was applied for and approved by the German Research 
Foundation (DFG). Changes and additions to the study protocol are listed below: 
 
3. Changes in the study protocol  
Following approval of a cost-neutral extension, the recruitment period was extended to 32 
months and the total duration of the study to 48 months. 
As part of a follow-up project, a 2-year catamnesis will also be carried out, resulting in a 
duration of 68 months for the main project and follow-up project (Figure 1).  
 
Figure 1: Time flow 
 
 
Figure 2 shows the study design supplemented by the new survey time point. There is no 
change in the form of intervention or dose. 
 
Year 
2022 
2023 
2024 
2025 
2026  
2027 
Quarter 
1 2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
 
Main study 
 
Initiation of sites 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention and 
follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Database 
cleaning and 
analyses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Publication 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2- Jahres FU 
 
Assessments  
2-year  
follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Database 
cleaning 
and analyses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Publication 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2 
 
 
Figure 2: Study design 
 
Data collection: 
The same data will be collected as at the follow-up time T2, only two questionnaires will no 
longer be collected (Partnership Questionnaire-Short Version (PFB-K, (Kliem et al., 2012)) 
and Inventory for the Assessment of Negative Effects of Psychotherapy (INEP, (Ladwig et 
al., 2014)); instead, open questions on side effects will be used. A qualitative survey of the 
study patients on the positive and negative change processes and ideas for treatment 
improvements has already been developed and is running in parallel with the follow-up 
examinations. 
 
Course of the study: 
Assessment at visit 18 (follow-up, T2) is repeated two years after the end of the intervention 
(visit 14) (Figure 3). The study can be conducted in person on site with the study participants 
or online using a data protection-compliant tool (see point 5. Data protection). 
 
Outcome and statistical analyses:  
The primary and secondary outcome criteria were expanded by the (clinically significant) 
change from baseline to 2-year follow-up, the statistical evaluation methods were retained. 
 
 
 
 
 
 
 
 
 
 

 
3 
 
 
STUDIENABSCHNITT 
 
 
Enr
olm
ent 
Randomization and Baseline 
T0 
Intervention 
Post 
Treatment 
T1 
Booster 
sessions 
Follow 
Up  
T2 
2-Year-
Follow 
Up 
T3 
Visit 
V1 
V2 
V3 
V4 
V5 - V14 
V15 
V16 / V17 
V18 
V19 
Screening 
X 
X 
 
 
 
 
 
 
 
Informed consent  
 
X 
 
 
 
 
 
 
X 
Inclusion and 
Exclusion criteria 
 
X 
 
 
 
 
 
 
 
Anamnesis and 
Demographics 
 
 
 
X 
 
 
 
 
 
Module „S“ DSF* 
 
X 
 
 
 
 
 
X 
X 
GEEE 
 
 
X 
 
X (V10) 
 
 
 
 
Randomization 
 
 
 
X 
 
 
 
 
 
INTERVENTION
: 
 
 
 
 
 
 
 
 
 
CBT 
 
 
 
 
X 
 
X 
 
 
EXP 
 
 
 
 
X 
 
X 
 
 
ASSESSMENTS: 
 
 
 
 
 
 
 
 
 
Accompanying 
treatments 
 
 
 
X 
X 
X 
X 
X 
X 
Pain 
medication** 
 
 
 
X 
X 
X 
X 
X 
X 
QBPDS 
 
X 
 
 
 
X 
 
X 
X 
Mini DIPS 
 
 
 
X 
 
 
 
 
 
LPFS-BF and 
PID5BF+M 
 
X 
 
 
 
 
 
 
 
PDI 
 
 
X 
 
X 
X 
X 
X 
X 
DSF*** 
 
 
X 
 
X 
X 
X 
X 
X 
FESV**** 
 
 
X 
 
 
X 
 
X 
X 
HADS 
 
 
X 
 
 
X 
 
X 
X 
PCS 
 
 
X 
 
 
X 
 
X 
X 
PHODA- SeV 
 
 
X 
 
 
X 
 
X 
X 
PASS-20 
 
 
X 
 
 
X 
 
X 
X 
BAT-BACK 
 
 
X 
 
 
X 
 
X 
X 
PIPS 
 
 
X 
 
 
X 
 
X 
X 
PFB-K 
 
 
X 
 
 
X 
 
X 
 
Qualitative survey 
on side effects, 
accompanying 
interventions and 
change processes. 
 
 
 
 
 
 
 
 
X 
WAI-SR 
 
 
 
 
X (V7, V10, V13) 
 
X 
 
 
REV***** 
 
 
 
 
X (V8-V14) 
 
 
 
 

 
4 
 
INEP 
 
 
 
 
X (V7, V10, V13) 
 
X 
 
 
Side effects 
checklist 
 
 
 
 
X (V7, V10, V13) 
 
X 
 
 
Figure 3: Visit plan 
* Module on the socio-legal situation, absenteeism ** including adjuvant pain medication (antidepressants) 
*** adapted scales on pain intensity and experienced impairment **** Coping scale ***** only in EXP condition 
4.  Amendment of the study information and declaration of consent 
An amendment to the existing study information and consent form was prepared, in which the 
extended catamnesis period, the data collected here and all aspects associated with further 
participation (duration, scope, objectives) are explained in detail.  Study participants have 
indicated in the written consent for the main object whether they may be contacted again in 
the event of a follow-up study. If consent is given, the study participants will be contacted at 
the 6-month follow-up or thereafter and informed consent to participate in the 2-year 
catamnesis will be obtained. All information collected is subject to the applicable data 
protection regulations. 
5. Data protection and Data security 
The collection and storage of the new data is pseudonymized under the study ID assigned for 
Visit 2. The data protection regulations in accordance with the DSGVO will be fully complied 
with. The existing security measures will be expanded and adapted to the new data collection 
modalities (e.g. online) so that the integrity and confidentiality of the data are guaranteed at all 
times. An online tool with video transmission can be used to carry out the survey. For this 
purpose, we use the services of Arztkonsultation ak GmbH, Schusterstraße 3, 19055 
Schwerin. Video transmissions via Arztkonsultation are end-to-end encrypted. This means that 
no one other than the participating persons can view the content of the transmission.  
6. Risk and benefits 
The additional examinations are associated with minimal burden for the study participants. No 
new measures will be collected. The extended follow-up enables a more in-depth analysis of 
the long-term effects, which can contribute to better scientific knowledge and potentially 
optimized treatment strategies. 
7. Study registration 
The study has been registered in the following public registry: U.S. NIH ClinicalTrials.gov 
Registration number: NCT05294081. The data were supplemented by the collection of the 2-
year catamnesis. The study coordinator at the lead study center is responsible for registering 
in the registry and maintaining the registry data. 
References 
 
Kliem, S., Job, A.-K., Kröger, C., Bodenmann, G., Stöbel-Richter, Y., Hahlweg, K., & Brähler, E. (2012). 
Entwicklung und Normierung einer Kurzform des Partnerschaftsfragebogens (PFB-K) an einer 
repräsentativen deutschen Stichprobe. Zeitschrift für Klinische Psychologie und Psychotherapie, 41(2), 
81–89. https://doi.org/10.1026/1616-3443/a000135 

 
5 
 
Ladwig, I., Rief, W., & Nestoriuc, Y. (2014). Welche Risiken und Nebenwirkungen hat Psychotherapie? - 
Entwicklung des Inventars zur Erfassung Negativer Effekte von Psychotherapie (INEP). 
Verhaltenstherapie, 24(4), 252–263. https://doi.org/10.1159/000367928